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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

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.

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

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. 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

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

NCT ID

NCT04886596

First Posted

April 29, 2021

Last Updated

July 14, 2023

Sponsor

GlaxoSmithKline

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

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

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

Description

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

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

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

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

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

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

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

Description

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

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

Description

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

Description

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

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

Description

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

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

Description

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

Description

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

Description

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

Description

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

Description

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

Description

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

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

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

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

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

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

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

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

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

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

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

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

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

Time Frame

Title

Number of Participants With Related SAEs and Fatal SAEs

Description

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

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

Respiratory Syncytial Virus Infections

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial