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Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
RSVPreF3 OA vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Syncytial Virus Infections focused on measuring Respiratory syncytial virus, Lower respiratory tract disease, Efficacy study, Adults aged 60 years and above

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A male or female ≥ 60 YOA at the time of first vaccination, who live in the community (community dwelling participants) or in a long-term care facility (LTCF) (LTCF participants).
  • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

Note: In case of physical incapacity that would preclude the self-completion of the diary cards and/or questionnaires, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home or in the LTCF). However, at no time, the site staff or caregiver will evaluate the participant's health status while answering diaries and/or questionnaires or make decisions on behalf of the participant

  • Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure.
  • Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable

Exclusion Criteria:

Medical conditions

  • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required).
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Hypersensitivity to latex.
  • Serious or unstable chronic illness.
  • Any history of dementia or any medical condition that moderately or severely impairs cognition.

Note: If deemed necessary for clinical evaluation, the investigator can use tools such as Mini-Mental State Exam (MMSE), Mini-Cog or Montreal Cognitive Assessment (MoCA) to determine cognition levels of the participant.

  • Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol.
  • Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.

Prior/Concomitant therapy

  • Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the first study vaccine administration, or planned use during the study period.
  • Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study vaccine administration, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study vaccination.
  • Previous vaccination with an RSV vaccine.
  • Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
  • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first study vaccine or planned administration during the study period.
  • Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first study vaccine administration or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.

Prior/Concurrent clinical study experience

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device).

Other exclusions

  • History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
  • Bedridden participants.
  • Planned move during the study period that will prohibit participating in the trial until study end. This includes:

    • Planned move during the study period to another LTCF that will prohibit participation in the trial until study end.
    • Planned move from the community to a LTCF that will prohibit participation in the trial until study end.
  • Participation of any study personnel or their immediate dependants, family, or household members.
  • Planned leave or holiday of 4 consecutive weeks or more during the RSV seasons* covered by the study, that would prohibit the reporting of ARI cases and attendance to ARI visit.

    • RSV seasons are from October to April in NH and from March to September in SH.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RSVPreF3 Group

Placebo Group

Arm Description

Participants in this group received a single dose the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants will be re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine every subsequent year; participants in the other receiving a dose of placebo every subsequent year.

Participants in this group received 1 dose of placebo at Day 1 and will receive an additional dose of placebo every subsequent year.

Outcomes

Primary Outcome Measures

Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine
First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD during the first season was assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of at least one RSV-positive swab detected by RT-PCR.

Secondary Outcome Measures

Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
Efficacy of a single dose of the RSVPreF3 OA vaccine will be assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine will be assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.
Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
Efficacy of a single dose of the RSVPreF3 OA vaccine was assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition. Results for the entire study period will be updated at the final results disclosure stage.
Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine will be assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.
Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Other Respiratory Pathogens Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
Efficacy of a single dose of the RSVPreF3 OA vaccine will be assessed against LRTD episode caused by other respiratory pathogens over 3 seasons according to the case definition. A LRTD caused by other respiratory pathogens is characterized by at least one positive swab for other respiratory pathogens detected by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.
Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Other Respiratory Pathogens Over 3 Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine will be assessed against LRTD episode caused by other respiratory pathogens over 3 seasons according to the case definition. A LRTD caused by other respiratory pathogens is characterized by at least one positive swab for other respiratory pathogens detected by RT-PCR. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.
Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses was assessed against RSV A and/or B confirmed LRTD episode according to the case definition, in the following age categories: ≥65 YOA, ≥70 YOA and ≥80 YOA. Results for LRTD by age will be updated at the final results disclosure stage.
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses will be assessed against RSV A and/or B confirmed LRTD episode according to the case definition, by RSV season as follows: VE after each season includes the first occurrence of episodes reported from at least one-month post vaccination at first season, and for the next seasons, excluding analysis of participants who already reported a case in the previous season. The RSV season may be extended based on epidemiology data. Results for LRTD by Season will be updated at the final results disclosure stage.
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses will be assessed against RSV A and/or B confirmed LRTD episode according to the case definition, by years after vaccination as follows: VE at each year includes the first occurrence of episodes reported from at least one month post vaccination at first year, and for the next years, excluding analysis of participants who already reported a case in the previous year. Results for LRTD by year will be updated during final result posting stage.
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated LRTD episode by baseline comorbidities (such as COPD, asthma, any chronic respiratory or pulmonary disease, diabetes mellitus type 1 or 2, chronic heart failure and advanced liver or renal disease) and according to Charlson Comorbidity Index. Low/medium Risk = Participants with co-morbidity score at baseline less than or equal to 3 (Charlson Index); High Risk = Participants with co-morbidity score at baseline greater than 3 (Charlson Index). Results for LRTD by baseline comorbidities will be updated at the final results disclosure stage.
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and /or B associated LRTD episode according to the case definition, by baseline frailty status of frail, pre-frail and fit. Frail = Participants with a walking speed <0.4m/s or who were not able to perform the test; Pre-Frail = Participants with a walking speed between 0.4-0.99 m/s; Fit = Participants with a walking speed >=1 m/s. Results for LRTD by baseline frailty status will be updated at the final results disclosure stage.
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated severe LRTD episode. An RT-PCR confirmed case of RSV-associated severe LRTD is characterized by presence of lower respiratory signs or an LRTD episode assessed as severe by the investigator (case definition 1) or presence of an LRTD with need for oxygen supplementation or need for positive airway pressure therapy or need for other types of mechanical ventilation (case definition 2) and with at least one RSV positive swab detected by RT-PCR. Results for severe LRTD will be updated at the final results disclosure stage.
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Acute Respiratory Illness (ARI) Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV confirmed A and/or B associated ARI episode. A case of RT-PCR confirmed RSV-associated ARI is characterized by the presence of respiratory symptoms/signs for at least 24 hours OR respiratory symptom/sign + systemic symptom/sign for at least 24 hours with at least one RSV-positive swab detected by RT-PCR. Results for RSV A and/or B Associated ARI will be updated at the final results disclosure stage.
Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses will be assessed against any ARI and any LRTD. Results for the entire study period will be updated at the final results disclosure stage.
Number of Hospitalizations Due to Respiratory Diseases or Due to a Complication Related to Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
A diagnosis of respiratory disease include: acute respiratory illnesses, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system. Results for the entire study period will be updated at the final results disclosure stage.
Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
RSV infection was confirmed by RT-PCR. Results for this outcome measure is not disclosed at this stage in order to maintain blinding within the ongoing trial. Data will be added at the final results posting stage.
Number of Complications Related to ARI and RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
RSV infection is confirmed by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.
Maximum Influenza Patient- Reported Outcome (Flu-PRO) Chest Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
The Health Related -Quality of life (HR-QOL) score is measured by Flu-PRO questionnaire. The Flu-PRO is a 32 items daily diary, which assesses influenza signs across 6 body systems- Nose, throat, eyes, chest/respiratory, gastrointestinal and body/systemic. The FLU-PRO total score is computed as the mean score across all 32 items, with the total scores ranging from 0 (symptom free) to 4 (very severe symptoms). Results for the entire study period will be updated at the final results disclosure stage.
Least Square Mean Flu-PRO Total Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Individual questions are assessed on the 5-point response categories and Flu-PRO total score is tabulated. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.
EuroQol 5-dimension Health Questionnaire (EQ-5D) Utility Score for Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
The EQ-5D is a general health utility questionnaire with health states, defined through 5 dimensions- mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. The health states indicated in these 5 dimensions are converted and presented as a single mean index value as recommended by EuroQol group. Values range from 0 (worst) to 1 (full health). Results for the entire study period will be updated at the final results disclosure stage.
Short Form-12 (SF-12) Physical Functioning Score for Participants With RT-PCR Confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
SF-12 is a health survey with 12 questions, covering 8 domains- physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Summary scores are computed from these domains for the physical and mental component. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. Results for the entire study period will be updated at the final results disclosure stage.
Duration of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes
The duration in days of RT-PCR confirmed RSV ARI and LRTD episodes will be described. Results for the entire study period will be updated at the final results disclosure stage.
Number of Participants With Each Reported Symptom/Sign of RT-PCR Confirmed RSV A and/or B ARI Episodes
RSV infection is confirmed by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.
Number of Participants With Each Reported Symptom/Sign of RT-PCR Confirmed RSV A and/or B LRTD Episodes
RSV infection is confirmed by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.
Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity
RSV A and/or B ARI and LRTD episodes assessed as 'severe' by the investigator. Severe is defined as "An ARI/LRTD episode which prevents normal, everyday activities. Such an event would, for example, prevent attendance at work and would necessitate the administration of corrective therapy". Number of subjects with Severe ARI and Severe LRTD episodes has not been disclosed at this stage in order to maintain blinding within the ongoing trial. It will be added at the final results posting stage. Results for the entire study period will be updated at the final results disclosure stage
RSVPreF3 Specific Immunoglobulin G (IgG) Antibody Concentrations
The RSV IgG antibody concentrations are measures as Geometric Mean Concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).
RSVPreF3 Specific Immunoglobulin G (IgG) Antibody Concentrations
The RSV IgG antibody concentrations are measures as Geometric Mean Concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
RSV A Neutralizing Antibody Titers
RSV A neutralizing antibodies are given as Geometric Mean Titers (GMTs) and expressed as Estimated Dilution 60 (ED60).
RSV A Neutralizing Antibody Titers
RSV A neutralizing antibodies are given as Geometric Mean Titers (GMTs) and expressed as Estimated Dilution 60 (ED60). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
RSV B Neutralizing Antibody Titers
RSV B neutralizing antibodies are given as GMTs.
RSV B Neutralizing Antibody Titers
RSV B neutralizing antibodies are given as GMTs. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events
Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. Grade 3 AE = an AE which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling. Number of participants with grade 3 AEs has not been disclosed at this stage in order to maintain blinding within the ongoing trial. Those will be added at the final results posting stage.
Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events
Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. Grade 3 AE = an AE which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events
Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. Grade 3 AE = an AE which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events
The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic). Number of subjects with Grade 3 Fever and Grade 3 Headache has not been disclosed at this stage in order to maintain blinding within the ongoing trial. It will be added at the final results posting stage.
Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events
The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events
The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Number of Days With Solicited Administration Site Adverse Events
Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. The assessed administration site events include pain, erythema and swelling.
Number of Days With Solicited Administration Site Adverse Events
Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. The assessed administration site events include pain, erythema and swelling. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Number of Days With Solicited Administration Site Adverse Events
Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. The assessed administration site events include pain, erythema and swelling. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Number of Days With Solicited Systemic Adverse Events
The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic).
Number of Days With Solicited Systemic Adverse Events
The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Number of Days With Solicited Systemic Adverse Events
The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Number of Participants With Any Unsolicited AEs
An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Number of Participants With Any Unsolicited AEs
An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Number of Participants With Any Unsolicited AEs
An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Number of Participants With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Results for the entire study period will be updated at the final results disclosure stage.
Number of Participants With Potential Immune Mediated Diseases (pIMDs)
pIMDs are a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Results for the entire study period will be updated at the final results disclosure stage.
Number of Participants With Related SAEs and Fatal SAEs
Related SAEs and fatal SAEs that occur throughout the study are assessed. Related SAEs= Any SAE related to investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator. Fatal SAEs= Any SAEs leading to deaths. Results for the entire study period will be updated at the final results disclosure stage.
Number of Participants With Related pIMDs
pIMDs are a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related pIMD = pIMD assessed by the investigator as related to the study vaccination. Results for the entire study period will be updated at the final results disclosure stage.

Full Information

First Posted
April 29, 2021
Last Updated
July 14, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT04886596
Brief Title
Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
Official Title
A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 25, 2021 (Actual)
Primary Completion Date
April 11, 2022 (Actual)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.
Detailed Description
Dose 1 Period will be conducted in 2 parts: Part 1: Participants in RSVPreF3 groups will receive lots 1, 2 and 3 of the investigational vaccine before Season 1. Part 2: Will be initiated when the vaccine lots in part 1 are exhausted at the study sites and participants in RSVPreF3 group will receive lot 4 of the investigational vaccine before Season 1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
Respiratory syncytial virus, Lower respiratory tract disease, Efficacy study, Adults aged 60 years and above

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This is an observer blind study.
Allocation
Randomized
Enrollment
26665 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RSVPreF3 Group
Arm Type
Experimental
Arm Description
Participants in this group received a single dose the RSVPreF3 OA vaccine at Day 1. Before the second vaccination participants will be re-randomized into 2 groups: participants in one receiving an additional dose of RSVPreF3 OA vaccine every subsequent year; participants in the other receiving a dose of placebo every subsequent year.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Participants in this group received 1 dose of placebo at Day 1 and will receive an additional dose of placebo every subsequent year.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered intramuscularly into the deltoid of the non-dominant arm at day 1 and before each subsequent RSV season to the Placebo Group, and before each subsequent RSV season to the participants of the RSVPreF3 Group, that are re-randomized to the RSV_1dose group.
Intervention Type
Biological
Intervention Name(s)
RSVPreF3 OA vaccine
Intervention Description
RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at Day 1 in the RSVPreF3 group, and before each subsequent RSV season to the participants of the RSVPreF3 group, that are re-randomized to the RSV_annual group.
Primary Outcome Measure Information:
Title
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine
Description
First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD during the first season was assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of at least one RSV-positive swab detected by RT-PCR.
Time Frame
From Day 15 post-vaccination up to end of season 1 in the Northern Hemisphere (NH) [assessed approximately 6.7 months per participant]
Secondary Outcome Measure Information:
Title
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
Description
Efficacy of a single dose of the RSVPreF3 OA vaccine will be assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame
From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the Northern Hemishpere (NH) (assessed approximately over 2 and 3 years in NH, and 1.5-2 and 2.5-3 years in Southern Hemisphere [SH])
Title
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD Over Several Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
Description
Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine will be assessed against RSV A and/or B confirmed LRTD over several seasons according to the case definition. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.
Time Frame
From Day 15 post first vaccination up to end of season 2 and up to end of season 3 in the Northern Hemisphere (NH) (assessed approximately over 2 and 3 years in NH, and 1.5-2 and 2.5-3 years in Southern Hemisphere [SH])
Title
Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
Description
Efficacy of a single dose of the RSVPreF3 OA vaccine was assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame
From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (assessed approximately over 3 years in the NH and 2.5-3 years in Southern Hemisphere [SH])
Title
Number of Participants With First Episode of RT-PCR Confirmed RSV Subtype A and Subtype B LRTD Over 3 Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
Description
Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine will be assessed against LRTD episode caused by RSV A and B subtype over 3 seasons according to the case definition. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.
Time Frame
From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])
Title
Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Other Respiratory Pathogens Over 3 Seasons Following a Single Dose of the RSVPreF3 OA Vaccine
Description
Efficacy of a single dose of the RSVPreF3 OA vaccine will be assessed against LRTD episode caused by other respiratory pathogens over 3 seasons according to the case definition. A LRTD caused by other respiratory pathogens is characterized by at least one positive swab for other respiratory pathogens detected by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame
From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])
Title
Number of Participants With First Episode of RT-PCR Confirmed LRTD Caused by Other Respiratory Pathogens Over 3 Seasons Following Annual Revaccination Doses of the RSVPreF3 OA Vaccine
Description
Efficacy of annual revaccination doses of the RSVPreF3 OA vaccine will be assessed against LRTD episode caused by other respiratory pathogens over 3 seasons according to the case definition. A LRTD caused by other respiratory pathogens is characterized by at least one positive swab for other respiratory pathogens detected by RT-PCR. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.
Time Frame
From Day 15 post first vaccination up to end of season 3 in the Northern Hemisphere (NH) (approximately 3 years for NH and 2.5-3 years for Southern Hemisphere [SH])
Title
Number of Participants With First Episode of RT-PCR Confirmed RSV A and /or B Associated LRTD, by Age Categories Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses was assessed against RSV A and/or B confirmed LRTD episode according to the case definition, in the following age categories: ≥65 YOA, ≥70 YOA and ≥80 YOA. Results for LRTD by age will be updated at the final results disclosure stage.
Time Frame
From Day 15 post first dose to the first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Title
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by RSV Season Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses will be assessed against RSV A and/or B confirmed LRTD episode according to the case definition, by RSV season as follows: VE after each season includes the first occurrence of episodes reported from at least one-month post vaccination at first season, and for the next seasons, excluding analysis of participants who already reported a case in the previous season. The RSV season may be extended based on epidemiology data. Results for LRTD by Season will be updated at the final results disclosure stage.
Time Frame
From Day 15 post first-vaccination or start of the RSV season to the first occurrence of RSV-confirmed LRTD at each RSV season (assessed approximately over 7 months at each season
Title
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Year Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses will be assessed against RSV A and/or B confirmed LRTD episode according to the case definition, by years after vaccination as follows: VE at each year includes the first occurrence of episodes reported from at least one month post vaccination at first year, and for the next years, excluding analysis of participants who already reported a case in the previous year. Results for LRTD by year will be updated during final result posting stage.
Time Frame
From Day 15 post first and each revaccination dose up to next dose or end of study (assessed approximately over a year after each vaccination)
Title
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Comorbidities Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated LRTD episode by baseline comorbidities (such as COPD, asthma, any chronic respiratory or pulmonary disease, diabetes mellitus type 1 or 2, chronic heart failure and advanced liver or renal disease) and according to Charlson Comorbidity Index. Low/medium Risk = Participants with co-morbidity score at baseline less than or equal to 3 (Charlson Index); High Risk = Participants with co-morbidity score at baseline greater than 3 (Charlson Index). Results for LRTD by baseline comorbidities will be updated at the final results disclosure stage.
Time Frame
From Day 15 post first and each revaccination dose to first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Title
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated LRTD by Baseline Frailty Status Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and /or B associated LRTD episode according to the case definition, by baseline frailty status of frail, pre-frail and fit. Frail = Participants with a walking speed <0.4m/s or who were not able to perform the test; Pre-Frail = Participants with a walking speed between 0.4-0.99 m/s; Fit = Participants with a walking speed >=1 m/s. Results for LRTD by baseline frailty status will be updated at the final results disclosure stage.
Time Frame
From Day 15 post first and each revaccination dose to first occurrence of RSV LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Title
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Severe LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV A and/or B associated severe LRTD episode. An RT-PCR confirmed case of RSV-associated severe LRTD is characterized by presence of lower respiratory signs or an LRTD episode assessed as severe by the investigator (case definition 1) or presence of an LRTD with need for oxygen supplementation or need for positive airway pressure therapy or need for other types of mechanical ventilation (case definition 2) and with at least one RSV positive swab detected by RT-PCR. Results for severe LRTD will be updated at the final results disclosure stage.
Time Frame
From Day 15 post first and each revaccination dose to the first occurrence of RSV severe LRTD (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Title
Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Acute Respiratory Illness (ARI) Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses is assessed against RSV confirmed A and/or B associated ARI episode. A case of RT-PCR confirmed RSV-associated ARI is characterized by the presence of respiratory symptoms/signs for at least 24 hours OR respiratory symptom/sign + systemic symptom/sign for at least 24 hours with at least one RSV-positive swab detected by RT-PCR. Results for RSV A and/or B Associated ARI will be updated at the final results disclosure stage.
Time Frame
From Day 15 post first and each revaccination dose to first occurrence of RSV ARI (assessed approximately over 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Title
Number of Participants With First Episode of Any ARI or Any LRTD Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description
Efficacy of a single dose of the RSVPreF3 OA vaccine and annual revaccination doses will be assessed against any ARI and any LRTD. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame
From Day 15 post first vaccination up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
Title
Number of Hospitalizations Due to Respiratory Diseases or Due to a Complication Related to Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description
A diagnosis of respiratory disease include: acute respiratory illnesses, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame
From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
Title
Number of Hospitalizations Due to RSV-confirmed Respiratory Diseases or Due to Complication Related to RSV-confirmed Respiratory Diseases, During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description
RSV infection was confirmed by RT-PCR. Results for this outcome measure is not disclosed at this stage in order to maintain blinding within the ongoing trial. Data will be added at the final results posting stage.
Time Frame
From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
Title
Number of Complications Related to ARI and RSV-confirmed ARI During the RSV Seasons Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description
RSV infection is confirmed by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame
From start of the first RSV season up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
Title
Maximum Influenza Patient- Reported Outcome (Flu-PRO) Chest Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description
The Health Related -Quality of life (HR-QOL) score is measured by Flu-PRO questionnaire. The Flu-PRO is a 32 items daily diary, which assesses influenza signs across 6 body systems- Nose, throat, eyes, chest/respiratory, gastrointestinal and body/systemic. The FLU-PRO total score is computed as the mean score across all 32 items, with the total scores ranging from 0 (symptom free) to 4 (very severe symptoms). Results for the entire study period will be updated at the final results disclosure stage.
Time Frame
During the first 7 days from the onset of ARI symptoms (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
Title
Least Square Mean Flu-PRO Total Score for the Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description
Individual questions are assessed on the 5-point response categories and Flu-PRO total score is tabulated. Participants in RSVPreF3 groups will be randomized before Season 2 into 2 sub-groups (RSV_annual group and RSV_1dose group). Results for RSV_annual group and RSV_1dose group of subsequent seasons will be updated during final posting.
Time Frame
During the first 7 days from the onset of ARI symptoms (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
Title
EuroQol 5-dimension Health Questionnaire (EQ-5D) Utility Score for Participants With RT-PCR-confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description
The EQ-5D is a general health utility questionnaire with health states, defined through 5 dimensions- mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. The health states indicated in these 5 dimensions are converted and presented as a single mean index value as recommended by EuroQol group. Values range from 0 (worst) to 1 (full health). Results for the entire study period will be updated at the final results disclosure stage.
Time Frame
At the ARI visit (assessed from 2 weeks post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
Title
Short Form-12 (SF-12) Physical Functioning Score for Participants With RT-PCR Confirmed RSV A and/or B-associated ARI Following a Single Dose of the RSVPreF3 OA Vaccine and Following Annual Revaccination Doses
Description
SF-12 is a health survey with 12 questions, covering 8 domains- physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Summary scores are computed from these domains for the physical and mental component. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame
At the ARI visit (assessed from one-month post first vaccination dose until end of study- approximately 3 years in NH and 2.5-3 years in SH)
Title
Duration of RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes
Description
The duration in days of RT-PCR confirmed RSV ARI and LRTD episodes will be described. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame
Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Title
Number of Participants With Each Reported Symptom/Sign of RT-PCR Confirmed RSV A and/or B ARI Episodes
Description
RSV infection is confirmed by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame
Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Title
Number of Participants With Each Reported Symptom/Sign of RT-PCR Confirmed RSV A and/or B LRTD Episodes
Description
RSV infection is confirmed by RT-PCR. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame
Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Title
Number of Participants With RT-PCR Confirmed RSV A and/or B ARI and LRTD Episodes According to Severity
Description
RSV A and/or B ARI and LRTD episodes assessed as 'severe' by the investigator. Severe is defined as "An ARI/LRTD episode which prevents normal, everyday activities. Such an event would, for example, prevent attendance at work and would necessitate the administration of corrective therapy". Number of subjects with Severe ARI and Severe LRTD episodes has not been disclosed at this stage in order to maintain blinding within the ongoing trial. It will be added at the final results posting stage. Results for the entire study period will be updated at the final results disclosure stage
Time Frame
Assessed during the study period (approximately 3 years in the Northern Hemisphere [NH] and 2.5-3 years in Southern Hemisphere [SH])
Title
RSVPreF3 Specific Immunoglobulin G (IgG) Antibody Concentrations
Description
The RSV IgG antibody concentrations are measures as Geometric Mean Concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).
Time Frame
At Day 1 (Pre-Dose 1) and Day 31
Title
RSVPreF3 Specific Immunoglobulin G (IgG) Antibody Concentrations
Description
The RSV IgG antibody concentrations are measures as Geometric Mean Concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame
Pre-season 2 (approximately 10-17 months post day 1 in NH; 12-21 months post day 1 in SH) and pre-season 3 (approximately 24-27 months post day 1, only in NH)
Title
RSV A Neutralizing Antibody Titers
Description
RSV A neutralizing antibodies are given as Geometric Mean Titers (GMTs) and expressed as Estimated Dilution 60 (ED60).
Time Frame
At Day 1 (Pre-Dose 1) and Day 31
Title
RSV A Neutralizing Antibody Titers
Description
RSV A neutralizing antibodies are given as Geometric Mean Titers (GMTs) and expressed as Estimated Dilution 60 (ED60). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame
Pre-season 2 (approximately 10-17 months post day 1 in NH; 12-21 months post day 1 in SH) and pre-season 3 (approximately 24-27 months post day 1, only in NH)
Title
RSV B Neutralizing Antibody Titers
Description
RSV B neutralizing antibodies are given as GMTs.
Time Frame
At Day 1 (Pre-Dose 1) and Day 31
Title
RSV B Neutralizing Antibody Titers
Description
RSV B neutralizing antibodies are given as GMTs. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame
Pre-season 2 (approximately 10-17 months post day 1 in NH; 12-21 months post day 1 in SH) and pre-season 3 (approximately 24-27 months post day 1, only in NH)
Title
Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events
Description
Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. Grade 3 AE = an AE which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling. Number of participants with grade 3 AEs has not been disclosed at this stage in order to maintain blinding within the ongoing trial. Those will be added at the final results posting stage.
Time Frame
During the 4-day follow up period after first vaccination (vaccine administered on Day 1)
Title
Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events
Description
Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. Grade 3 AE = an AE which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame
During the 4-day follow up period after second vaccination (vaccine administered pre-season 2)
Title
Number of Participants With Any, Grade 3 Solicited Administration Site Adverse Events
Description
Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. Grade 3 AE = an AE which prevented normal, everyday activities. The assessed administration site events include pain, erythema and swelling. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame
During the 4-day follow up period after the third vaccination (administered pre-season 3-only applicable for participants in Northern Hemisphere [NH]))
Title
Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events
Description
The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic). Number of subjects with Grade 3 Fever and Grade 3 Headache has not been disclosed at this stage in order to maintain blinding within the ongoing trial. It will be added at the final results posting stage.
Time Frame
During the 4-day follow up period after first vaccination (vaccine administered on Day 1)
Title
Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events
Description
The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame
During the 4-day follow up period after second vaccination (vaccine or placebo administered pre-season 2)
Title
Number of Participants With Any, Grade 3 Solicited Systemic Adverse Events
Description
The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame
During the 4-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere)
Title
Number of Days With Solicited Administration Site Adverse Events
Description
Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. The assessed administration site events include pain, erythema and swelling.
Time Frame
During the 4-day follow up period after first vaccination (vaccine or placebo administered on Day 1)
Title
Number of Days With Solicited Administration Site Adverse Events
Description
Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. The assessed administration site events include pain, erythema and swelling. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame
During the 4-day follow up period after second vaccination (vaccine administered pre-season 2)
Title
Number of Days With Solicited Administration Site Adverse Events
Description
Any solicited event is defined as the occurrence of any solicited adverse event (AE) regardless of intensity grade. The assessed administration site events include pain, erythema and swelling. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame
During the 4-day follow up period after third vaccination (vaccine administered pre-season 3-only applicable for participants in Northern Hemisphere [NH]))
Title
Number of Days With Solicited Systemic Adverse Events
Description
The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic).
Time Frame
During the 4-day follow up period after first vaccination (vaccine or placebo administered on Day 1)
Title
Number of Days With Solicited Systemic Adverse Events
Description
The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame
During the 4-day follow up period after second vaccination (vaccine or placebo administered pre-season 2)
Title
Number of Days With Solicited Systemic Adverse Events
Description
The assessed solicited systemic events include fever, headache, fatigue, myalgia and arthralgia. Fever is defined as a temperature ≥ 38.0°C/100.4°F by any route (oral/ axillary/tympanic). The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame
During the 4-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere [NH])
Title
Number of Participants With Any Unsolicited AEs
Description
An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame
During the 30-day follow up period after first vaccination (vaccine or placebo administered on Day 1)
Title
Number of Participants With Any Unsolicited AEs
Description
An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame
During the 30-day follow up period after second vaccination (vaccine administered pre-season 2)
Title
Number of Participants With Any Unsolicited AEs
Description
An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. The results for subsequent seasons will be updated during final posting.
Time Frame
During the 30-day follow up period after third vaccination (vaccine or placebo administered pre-season 3-only applicable for participants in Northern Hemisphere [NH])
Title
Number of Participants With Serious Adverse Events (SAEs)
Description
An SAE is defined as any untoward medical occurrence that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame
From the day of the vaccination up to 6 months after each vaccination (vaccine or placebo administered on Day 1, pre-season 2 and pre-season 3-only applicable for participants in Northern Hemisphere [NH])
Title
Number of Participants With Potential Immune Mediated Diseases (pIMDs)
Description
pIMDs are a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. The study is ongoing at the time of the results posting and only season 1 in Northern hemisphere (NH) data are available. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame
From the day of the vaccination up to 6 months after each vaccination (vaccine or placebo administered on Day 1, pre-season 2 and pre-season 3-only applicable for participants in Northern Hemisphere [NH])
Title
Number of Participants With Related SAEs and Fatal SAEs
Description
Related SAEs and fatal SAEs that occur throughout the study are assessed. Related SAEs= Any SAE related to investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator. Fatal SAEs= Any SAEs leading to deaths. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame
From Day 1 up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])
Title
Number of Participants With Related pIMDs
Description
pIMDs are a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related pIMD = pIMD assessed by the investigator as related to the study vaccination. Results for the entire study period will be updated at the final results disclosure stage.
Time Frame
From Day 1 up to study end (approximately 3 years for Northern Hemisphere [NH] and 2.5-3 years for Southern Hemisphere [SH])

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A male or female ≥ 60 YOA at the time of first vaccination, who live in the community (community dwelling participants) or in a long-term care facility (LTCF) (LTCF participants). Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Note: In case of physical incapacity that would preclude the self-completion of the diary cards and/or questionnaires, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home or in the LTCF). However, at no time, the site staff or caregiver will evaluate the participant's health status while answering diaries and/or questionnaires or make decisions on behalf of the participant Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure. Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable Exclusion Criteria: Medical conditions Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination (no laboratory testing required). History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. Hypersensitivity to latex. Serious or unstable chronic illness. Any history of dementia or any medical condition that moderately or severely impairs cognition. Note: If deemed necessary for clinical evaluation, the investigator can use tools such as Mini-Mental State Exam (MMSE), Mini-Cog or Montreal Cognitive Assessment (MoCA) to determine cognition levels of the participant. Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. Prior/Concomitant therapy Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the first study vaccine administration, or planned use during the study period. Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study vaccine administration, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study vaccination. Previous vaccination with an RSV vaccine. Administration of long-acting immune-modifying drugs or planned administration at any time during the study period. Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first study vaccine or planned administration during the study period. Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first study vaccine administration or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed. Prior/Concurrent clinical study experience • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device). Other exclusions History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures. Bedridden participants. Planned move during the study period that will prohibit participating in the trial until study end. This includes: Planned move during the study period to another LTCF that will prohibit participation in the trial until study end. Planned move from the community to a LTCF that will prohibit participation in the trial until study end. Participation of any study personnel or their immediate dependants, family, or household members. Planned leave or holiday of 4 consecutive weeks or more during the RSV seasons* covered by the study, that would prohibit the reporting of ARI cases and attendance to ARI visit. RSV seasons are from October to April in NH and from March to September in SH.
Facility Information:
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
GSK Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
GSK Investigational Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
GSK Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
GSK Investigational Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
GSK Investigational Site
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
GSK Investigational Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
GSK Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
GSK Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
GSK Investigational Site
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
GSK Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32934
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
GSK Investigational Site
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
GSK Investigational Site
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
GSK Investigational Site
City
Weeki Wachee
State/Province
Florida
ZIP/Postal Code
34607
Country
United States
Facility Name
GSK Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
GSK Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
GSK Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
GSK Investigational Site
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46544
Country
United States
Facility Name
GSK Investigational Site
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
GSK Investigational Site
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
GSK Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
GSK Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
GSK Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
GSK Investigational Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Facility Name
GSK Investigational Site
City
Richfield
State/Province
Minnesota
ZIP/Postal Code
55423
Country
United States
Facility Name
GSK Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
GSK Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
GSK Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
GSK Investigational Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
GSK Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
GSK Investigational Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
GSK Investigational Site
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
GSK Investigational Site
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
GSK Investigational Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
GSK Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
GSK Investigational Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
GSK Investigational Site
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
GSK Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
GSK Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
GSK Investigational Site
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16508
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
GSK Investigational Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
GSK Investigational Site
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
GSK Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37912
Country
United States
Facility Name
GSK Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
GSK Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
GSK Investigational Site
City
Keller
State/Province
Texas
ZIP/Postal Code
76248
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
GSK Investigational Site
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
GSK Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
GSK Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
GSK Investigational Site
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
GSK Investigational Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
GSK Investigational Site
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
GSK Investigational Site
City
Morayfield
State/Province
Queensland
ZIP/Postal Code
4506
Country
Australia
Facility Name
GSK Investigational Site
City
Taringa
State/Province
Queensland
ZIP/Postal Code
4068
Country
Australia
Facility Name
GSK Investigational Site
City
Tarragindi
State/Province
Queensland
ZIP/Postal Code
4121
Country
Australia
Facility Name
GSK Investigational Site
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
GSK Investigational Site
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
GSK Investigational Site
City
Spearwood
State/Province
Western Australia
ZIP/Postal Code
6163
Country
Australia
Facility Name
GSK Investigational Site
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
GSK Investigational Site
City
Alken
ZIP/Postal Code
3570
Country
Belgium
Facility Name
GSK Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
GSK Investigational Site
City
Erpent
ZIP/Postal Code
5101
Country
Belgium
Facility Name
GSK Investigational Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
GSK Investigational Site
City
Gozée
ZIP/Postal Code
6534
Country
Belgium
Facility Name
GSK Investigational Site
City
Gribomont
ZIP/Postal Code
6887
Country
Belgium
Facility Name
GSK Investigational Site
City
Halen
ZIP/Postal Code
3544
Country
Belgium
Facility Name
GSK Investigational Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
GSK Investigational Site
City
Ieper
ZIP/Postal Code
8900
Country
Belgium
Facility Name
GSK Investigational Site
City
Kluisbergen
ZIP/Postal Code
9690
Country
Belgium
Facility Name
GSK Investigational Site
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Facility Name
GSK Investigational Site
City
Stoumont
ZIP/Postal Code
4987
Country
Belgium
Facility Name
GSK Investigational Site
City
Tremelo
ZIP/Postal Code
3120
Country
Belgium
Facility Name
GSK Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5A 4L8
Country
Canada
Facility Name
GSK Investigational Site
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W4
Country
Canada
Facility Name
GSK Investigational Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3S 2N6
Country
Canada
Facility Name
GSK Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2T1
Country
Canada
Facility Name
GSK Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3M9
Country
Canada
Facility Name
GSK Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 4A1
Country
Canada
Facility Name
GSK Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3J 3G9
Country
Canada
Facility Name
GSK Investigational Site
City
Truro
State/Province
Nova Scotia
ZIP/Postal Code
B2N 1L2
Country
Canada
Facility Name
GSK Investigational Site
City
Greater Sudbury
State/Province
Ontario
ZIP/Postal Code
P3C 1X3
Country
Canada
Facility Name
GSK Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
GSK Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
GSK Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W 4L6
Country
Canada
Facility Name
GSK Investigational Site
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7Y8
Country
Canada
Facility Name
GSK Investigational Site
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
GSK Investigational Site
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
GSK Investigational Site
City
Québec City
State/Province
Quebec
ZIP/Postal Code
G1E 7G9
Country
Canada
Facility Name
GSK Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1J 2G2
Country
Canada
Facility Name
GSK Investigational Site
City
St. Charles-Borromee
State/Province
Quebec
ZIP/Postal Code
J6E 2B4
Country
Canada
Facility Name
GSK Investigational Site
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
GSK Investigational Site
City
Paide
ZIP/Postal Code
72713
Country
Estonia
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
10128
Country
Estonia
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
13619
Country
Estonia
Facility Name
GSK Investigational Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
GSK Investigational Site
City
Espoo
ZIP/Postal Code
02230
Country
Finland
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00930
Country
Finland
Facility Name
GSK Investigational Site
City
Jarvenpaa
ZIP/Postal Code
04400
Country
Finland
Facility Name
GSK Investigational Site
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
GSK Investigational Site
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
GSK Investigational Site
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
GSK Investigational Site
City
Seinajoki
ZIP/Postal Code
60100
Country
Finland
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
GSK Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
GSK Investigational Site
City
Wangen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
88239
Country
Germany
Facility Name
GSK Investigational Site
City
Weinheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69469
Country
Germany
Facility Name
GSK Investigational Site
City
Dachau
State/Province
Bayern
ZIP/Postal Code
85221
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80339
Country
Germany
Facility Name
GSK Investigational Site
City
Wallerfing
State/Province
Bayern
ZIP/Postal Code
94574
Country
Germany
Facility Name
GSK Investigational Site
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97070
Country
Germany
Facility Name
GSK Investigational Site
City
Floersheim
State/Province
Hessen
ZIP/Postal Code
65439
Country
Germany
Facility Name
GSK Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60313
Country
Germany
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30159
Country
Germany
Facility Name
GSK Investigational Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45355
Country
Germany
Facility Name
GSK Investigational Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45359
Country
Germany
Facility Name
GSK Investigational Site
City
Goch
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47574
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
51069
Country
Germany
Facility Name
GSK Investigational Site
City
Witten
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58455
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55116
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01279
Country
Germany
Facility Name
GSK Investigational Site
City
Freiberg
State/Province
Sachsen
ZIP/Postal Code
09599
Country
Germany
Facility Name
GSK Investigational Site
City
Freital
State/Province
Sachsen
ZIP/Postal Code
01705
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04347
Country
Germany
Facility Name
GSK Investigational Site
City
Schmiedeberg
State/Province
Sachsen
ZIP/Postal Code
01762
Country
Germany
Facility Name
GSK Investigational Site
City
Schenefeld
State/Province
Schleswig-Holstein
ZIP/Postal Code
22869
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
GSK Investigational Site
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
GSK Investigational Site
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
GSK Investigational Site
City
Cona (FE)
State/Province
Emilia-Romagna
ZIP/Postal Code
44124
Country
Italy
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
GSK Investigational Site
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Facility Name
GSK Investigational Site
City
Alessandria
State/Province
Piemonte
ZIP/Postal Code
15100
Country
Italy
Facility Name
GSK Investigational Site
City
Vercelli
State/Province
Piemonte
ZIP/Postal Code
13100
Country
Italy
Facility Name
GSK Investigational Site
City
Bari
State/Province
Puglia
ZIP/Postal Code
70121
Country
Italy
Facility Name
GSK Investigational Site
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90127
Country
Italy
Facility Name
GSK Investigational Site
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Facility Name
GSK Investigational Site
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
GSK Investigational Site
City
Belluno
State/Province
Veneto
ZIP/Postal Code
32100
Country
Italy
Facility Name
GSK Investigational Site
City
Negrar
State/Province
Veneto
ZIP/Postal Code
37024
Country
Italy
Facility Name
GSK Investigational Site
City
Chieri (TO)
ZIP/Postal Code
10023
Country
Italy
Facility Name
GSK Investigational Site
City
Chiba
ZIP/Postal Code
292-0805
Country
Japan
Facility Name
GSK Investigational Site
City
Hiroshima
ZIP/Postal Code
732-0053
Country
Japan
Facility Name
GSK Investigational Site
City
Ibaraki
ZIP/Postal Code
306-0041
Country
Japan
Facility Name
GSK Investigational Site
City
Kumamoto
ZIP/Postal Code
860-0863
Country
Japan
Facility Name
GSK Investigational Site
City
Okinawa
ZIP/Postal Code
901-2393
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
350-1122
Country
Japan
Facility Name
GSK Investigational Site
City
Shizuoka
ZIP/Postal Code
421-0193
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
121-0815
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
160-0017
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
165-0031
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
169-0072
Country
Japan
Facility Name
GSK Investigational Site
City
Yamagata
ZIP/Postal Code
990-0834
Country
Japan
Facility Name
GSK Investigational Site
City
Yamaguchi
ZIP/Postal Code
750-0061
Country
Japan
Facility Name
GSK Investigational Site
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Gyeonggi-do
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Gyeonggi
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Jeonju-si, Jeollabuk-do
ZIP/Postal Code
54907
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
07441
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Mexico City
State/Province
Ciudad De Mexico
ZIP/Postal Code
01120
Country
Mexico
Facility Name
GSK Investigational Site
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37530
Country
Mexico
Facility Name
GSK Investigational Site
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64570
Country
Mexico
Facility Name
GSK Investigational Site
City
Queretaro
State/Province
Querétaro
ZIP/Postal Code
76070
Country
Mexico
Facility Name
GSK Investigational Site
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97070
Country
Mexico
Facility Name
GSK Investigational Site
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Facility Name
GSK Investigational Site
City
Mexico City
ZIP/Postal Code
03100
Country
Mexico
Facility Name
GSK Investigational Site
City
Mexico City
ZIP/Postal Code
06760
Country
Mexico
Facility Name
GSK Investigational Site
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
GSK Investigational Site
City
San Luis Potosí
ZIP/Postal Code
78209
Country
Mexico
Facility Name
GSK Investigational Site
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
GSK Investigational Site
City
Havelock North
ZIP/Postal Code
4130
Country
New Zealand
Facility Name
GSK Investigational Site
City
Paraparaumu
ZIP/Postal Code
5032
Country
New Zealand
Facility Name
GSK Investigational Site
City
Tauranga
ZIP/Postal Code
3001
Country
New Zealand
Facility Name
GSK Investigational Site
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
GSK Investigational Site
City
Czestochowa
ZIP/Postal Code
42202
Country
Poland
Facility Name
GSK Investigational Site
City
Elblg
ZIP/Postal Code
82-300
Country
Poland
Facility Name
GSK Investigational Site
City
Gdansk
ZIP/Postal Code
80-382
Country
Poland
Facility Name
GSK Investigational Site
City
Gdynia
ZIP/Postal Code
81-537
Country
Poland
Facility Name
GSK Investigational Site
City
Katowice
ZIP/Postal Code
40-040
Country
Poland
Facility Name
GSK Investigational Site
City
Katowice
ZIP/Postal Code
40-282
Country
Poland
Facility Name
GSK Investigational Site
City
Katowice
ZIP/Postal Code
40-648
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
GSK Investigational Site
City
Lodz
ZIP/Postal Code
90-127
Country
Poland
Facility Name
GSK Investigational Site
City
Lodz
ZIP/Postal Code
91-363
Country
Poland
Facility Name
GSK Investigational Site
City
Piaseczno
ZIP/Postal Code
05-500
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
60-702
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
00-892
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
02-672
Country
Poland
Facility Name
GSK Investigational Site
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Facility Name
GSK Investigational Site
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
GSK Investigational Site
City
Wrocław
ZIP/Postal Code
50-381
Country
Poland
Facility Name
GSK Investigational Site
City
Barnaul
ZIP/Postal Code
656043
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620137
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Gatchina
ZIP/Postal Code
188300
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
196158
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St.Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
GSK Investigational Site
City
St.Petersburg
ZIP/Postal Code
196143
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Boksburg
State/Province
Gauteng
ZIP/Postal Code
1459
Country
South Africa
Facility Name
GSK Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1632
Country
South Africa
Facility Name
GSK Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1818
Country
South Africa
Facility Name
GSK Investigational Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2113
Country
South Africa
Facility Name
GSK Investigational Site
City
Moloto South
State/Province
Gauteng
ZIP/Postal Code
1022
Country
South Africa
Facility Name
GSK Investigational Site
City
Middelburg
State/Province
Mpumalanga
ZIP/Postal Code
1055
Country
South Africa
Facility Name
GSK Investigational Site
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
GSK Investigational Site
City
Mowbray
ZIP/Postal Code
7700
Country
South Africa
Facility Name
GSK Investigational Site
City
Alcorcón (Madrid)
ZIP/Postal Code
28922
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
Facility Name
GSK Investigational Site
City
Centelles (Barcelona)
ZIP/Postal Code
08540
Country
Spain
Facility Name
GSK Investigational Site
City
Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
GSK Investigational Site
City
La Roca del Vallès
ZIP/Postal Code
08430
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28029
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
GSK Investigational Site
City
Majadahonda (Madrid)
ZIP/Postal Code
28222
Country
Spain
Facility Name
GSK Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
GSK Investigational Site
City
Vic
ZIP/Postal Code
08500
Country
Spain
Facility Name
GSK Investigational Site
City
Peterborough
State/Province
Cambridgeshire
ZIP/Postal Code
PE8 6PL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Orpington
State/Province
Kent
ZIP/Postal Code
BR5 3QG
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bellshill
State/Province
Lanarkshire
ZIP/Postal Code
ML4 3NJ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Buckshaw Village, Chorley
State/Province
Lancashire
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Thetford
State/Province
Norfolk
ZIP/Postal Code
IP24 2HY
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Corby
State/Province
Northamptonshire
ZIP/Postal Code
NN17 2UR
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Leamington Spa
State/Province
Warwickshire
ZIP/Postal Code
CV32 4RA
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bradford on Avon
State/Province
Wiltshire
ZIP/Postal Code
BA15 1DQ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bebington
ZIP/Postal Code
CH63 9JP
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Belfast
ZIP/Postal Code
BT7 2EB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Eynsham
ZIP/Postal Code
OX29 4QB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Gwaelod-y-Garth, Cardiff
ZIP/Postal Code
CF15 9SS
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Hexham
ZIP/Postal Code
NE46 1QJ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Oxford
ZIP/Postal Code
OX4 1XB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Stockton On Tees
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Witney
ZIP/Postal Code
OX28 6JS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Learn more about this trial

Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

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