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A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults

Primary Purpose

Influenza, Human

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GSK4382276A Dose level 1
GSK4382276A Dose level 2
GSK4382276A Dose level 3
GSK4382276A Dose level 4
GSK4382276A Dose level 6
GSK4382276A Dose level 7
GSK4382276A Dose level 8
GSK4382276A Dose level 9
GSK4382276A Dose level 10
GSK4382276A Dose level 11
FDQ21A-NH
FDQ22A-NH
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring Influenza, Safety, Reactogenicity, Immunogenicity, mRNA vaccine, Healthy younger adults, Healthy older adults

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A male or female between and including 18 and 45 years of age (YAs) or between and including 60 and 80 years of age (OAs) at the time of the study intervention administration. The age of sentinel participants in OA category will be limited to maximum 70 years.
  • Healthy or medically stable participants as established by medical history, safety laboratory assessments and clinical examination.
  • Body mass index ≥ 18 kg/m^2 and ≤ 32 kg/m^2.
  • Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol
  • Written informed consent obtained from the participant prior to performing any study-specific procedure.
  • Female participants of non-childbearing potential may be enrolled in the study.
  • Female participants of childbearing potential may be enrolled in the study if the participant:

    • has practiced adequate contraception for 28 days prior to study intervention administration, and
    • has a negative pregnancy test on the day of study intervention administration, and
    • has agreed to continue adequate contraception for at least 1 month after study intervention administration.

Exclusion Criteria:

Medical conditions

  • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or review of the participant's medical record.
  • Any clinically significant* hematological coagulation or urine analysis laboratory abnormality.

    * The investigator should use his/her clinical judgement to decide which abnormalities are clinically significant.

  • Current or past malignancy, unless completely resolved without sequelae for >5 years.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, 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 study intervention (including latex, poly-ethylene-glycol, egg protein and aminoglycoside antibiotics).
  • Recurrent history or uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell's palsy, with the exception of febrile seizures during childhood.
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
  • Significant exposure to persons with influenza or laboratory-confirmed SARS-CoV-2 within 7 days prior to Visit 1 (Day 1) and for whom a SARS-CoV-2 PCR test has not (yet) been confirmed as negative.

Prior/Concomitant therapy

  • Administration of seasonal influenza vaccine within 180 days before enrollment or planned administration up to Visit 4 (Day 29).
  • Administration of a vaccine not foreseen by the study protocol in the period starting 28 days before the study intervention administration, or planned administration within 28 days after the study intervention administration*, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of the type of vaccine).

    *In case emergency mass vaccination for an unforeseen public health threat is organized by public health authorities outside the routine immunization program, the time period described above can be reduced to 7 days, if necessary, for that mass vaccination vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.

  • Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention during the period beginning 30 days before the study intervention administration, or their planned use during the study period.
  • Administration of long-acting immune-modifying drugs within 90 days before enrollment or planned use 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 study intervention administration, or planned administration during the study period. Administration of monoclonal antibodies specifically directed against the spike protein of SARS-CoV-2 virus, for treatment of COVID-19 disease is allowed.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the study intervention administration. For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day. Inhaled, topical and intraarticular steroids are allowed.

Other exclusions

  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period.
  • History of abusive alcohol and/or drug consumption in the past 5 years.
  • Any study personnel or their immediate dependents, family, or household members.
  • Participants with extensive tattoos covering deltoid region on both arms that would preclude the assessment of local reactogenicity.

Sites / Locations

  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational Site
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Experimental

Active Comparator

Arm Label

YA GSK4382276A Dose level 1 Group

YA GSK4382276A Dose level 2 Group

YA GSK4382276A Dose level 3 Group

YA GSK4382276A Dose level 4 Group

YA GSK4382276A Dose level 6 Group

YA GSK4382276A Dose level 7 Group

YA GSK4382276A Dose level 8 Group

YA GSK4382276A Dose level 9 Group

YA GSK4382276A Dose level 10 Group

YA GSK4382276A Dose level 11 Group

YA Control 1 Group

YA Control 2 Group

OA GSK4382276A Group

OA Control Group

Arm Description

Eligible young adults (YA) participants receive dose level 1 of GSK4382276A study intervention administered at Day 1.

Eligible young adults (YA) participants receive dose level 2 of GSK4382276A study intervention administered at Day 1.

Eligible young adults (YA) participants receive dose level 3 GSK4382276A study intervention administered at Day 1.

Eligible young adults (YA) participants receive dose level 4 of GSK4382276A study intervention administered at Day 1.

Eligible YA participants receive dose level 6 of GSK4382276A study intervention administered at Day 1.

Eligible YA participants receive dose level 7 of GSK4382276A study intervention administered at Day 1.

Eligible YA participants receive dose level 8 of GSK4382276A study intervention administered at Day 1.

Eligible YA participants receive dose level 9 of GSK4382276A study intervention administered at Day 1.

Eligible YA participants receive dose level 10 of GSK4382276A study intervention administered at Day 1.

Eligible YA participants receive dose level 11 of GSK4382276A study intervention administered at Day 1.

Eligible YA participants receive single dose of FDQ21A-NH administered at Day 1.

Eligible YA participants receive single dose of FDQ22A-NH administered at Day 1.

Eligible OA participants receive single dose of GSK4382276A study intervention at 1 dose level selected from the first 3 dose levels in YAs, administered at Day 1.

Eligible OA participants receive single dose of FDQ21A-NH administered at Day 1.

Outcomes

Primary Outcome Measures

Number of participants reporting each solicited administration site event
The following administration site events will be solicited: pain, redness, swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm).
Number of participants reporting each solicited systemic event
The following systemic events will be solicited: fever, headache, myalgia, arthralgia, fatigue, chills. Fever is defined as temperature ≥38°C/100.4°F regardless the location of measurement. The preferred location for measuring temperature is axillary.
Number of participants reporting unsolicited adverse events (AEs)
An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Number of participants reporting serious adverse events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or is an abnormal pregnancy outcome.
Number of participants reporting adverse events of special interest (AESIs)
The following events are considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs).
Number of participants reporting a shift from non-clinically significant laboratory value on Day 1 to clinically significant abnormal laboratory value on Day 8 or on Day 29 for hematology, clinical chemistry, coagulation and urine analysis
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition.
Geometric mean titers (GMT) of anti-vaccine antibody titers
GMT of anti-vaccine antibody titers
Geometric mean increase (GMI) of anti-vaccine antibody titers
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titer over the Day 1 anti-vaccine antibody titer.
Anti-vaccine antibody titers seroconversion rate (SCR)
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer < 1:10 and a post-dose anti-vaccine antibody titer ≥ 1:40 or a pre-dose anti-vaccine antibody titer ≥ 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer.
Anti-vaccine antibody seroprotection rate (SPR)
SPR is defined as the percentage of dosed participants with an anti-vaccine antibody titer ≥ 1:40.

Secondary Outcome Measures

GMT of anti-vaccine antibody titer.
GMI of anti-vaccine antibody titer
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titer over the Day 1 anti-vaccine antibody titer.
GMI of anti-vaccine antibody titer
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titer over the Day 1 anti-vaccine antibody titer.
Anti-vaccine antibody titer SPR
SPR is defined as the percentage of dosed participants with an anti-vaccine antibody titer ≥ 1:40.

Full Information

First Posted
June 28, 2022
Last Updated
August 11, 2023
Sponsor
GlaxoSmithKline
Collaborators
CureVac
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1. Study Identification

Unique Protocol Identification Number
NCT05446740
Brief Title
A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults
Official Title
A Phase 1 Randomized, Observer-blind, Dose-escalation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an mRNA-based Monovalent Influenza Vaccine Candidate in Healthy Younger and Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
April 12, 2024 (Anticipated)
Study Completion Date
April 12, 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this first-time-in-human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based monovalent vaccine (GSK4382276A) candidate against influenza in healthy younger adults (YA) and older adults (OA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
Keywords
Influenza, Safety, Reactogenicity, Immunogenicity, mRNA vaccine, Healthy younger adults, Healthy older adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study will be observer-blind with regards to the study intervention and open-label with regards to the dose level for participants and investigators and open-label for the sponsor. For dose cohorts 6, 7, 10 and 11 the study will be single-blind.
Allocation
Randomized
Enrollment
324 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
YA GSK4382276A Dose level 1 Group
Arm Type
Experimental
Arm Description
Eligible young adults (YA) participants receive dose level 1 of GSK4382276A study intervention administered at Day 1.
Arm Title
YA GSK4382276A Dose level 2 Group
Arm Type
Experimental
Arm Description
Eligible young adults (YA) participants receive dose level 2 of GSK4382276A study intervention administered at Day 1.
Arm Title
YA GSK4382276A Dose level 3 Group
Arm Type
Experimental
Arm Description
Eligible young adults (YA) participants receive dose level 3 GSK4382276A study intervention administered at Day 1.
Arm Title
YA GSK4382276A Dose level 4 Group
Arm Type
Experimental
Arm Description
Eligible young adults (YA) participants receive dose level 4 of GSK4382276A study intervention administered at Day 1.
Arm Title
YA GSK4382276A Dose level 6 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive dose level 6 of GSK4382276A study intervention administered at Day 1.
Arm Title
YA GSK4382276A Dose level 7 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive dose level 7 of GSK4382276A study intervention administered at Day 1.
Arm Title
YA GSK4382276A Dose level 8 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive dose level 8 of GSK4382276A study intervention administered at Day 1.
Arm Title
YA GSK4382276A Dose level 9 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive dose level 9 of GSK4382276A study intervention administered at Day 1.
Arm Title
YA GSK4382276A Dose level 10 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive dose level 10 of GSK4382276A study intervention administered at Day 1.
Arm Title
YA GSK4382276A Dose level 11 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive dose level 11 of GSK4382276A study intervention administered at Day 1.
Arm Title
YA Control 1 Group
Arm Type
Active Comparator
Arm Description
Eligible YA participants receive single dose of FDQ21A-NH administered at Day 1.
Arm Title
YA Control 2 Group
Arm Type
Active Comparator
Arm Description
Eligible YA participants receive single dose of FDQ22A-NH administered at Day 1.
Arm Title
OA GSK4382276A Group
Arm Type
Experimental
Arm Description
Eligible OA participants receive single dose of GSK4382276A study intervention at 1 dose level selected from the first 3 dose levels in YAs, administered at Day 1.
Arm Title
OA Control Group
Arm Type
Active Comparator
Arm Description
Eligible OA participants receive single dose of FDQ21A-NH administered at Day 1.
Intervention Type
Biological
Intervention Name(s)
GSK4382276A Dose level 1
Other Intervention Name(s)
Flu mRNA
Intervention Description
Dose level 1 of GSK4382276A is administered intramuscularly in the upper deltoid region of the non-dominant arm to participants in YA GSK4382276A Dose level 1 and OA GSK4382276A Selected Dose level from YA groups, at Day 1. Potential intermediate dose levels may be evaluated, with the total number of dose levels per age group not exceeding 5.
Intervention Type
Biological
Intervention Name(s)
GSK4382276A Dose level 2
Intervention Description
Dose level 2 of GSK4382276A is administered intramuscularly in the upper deltoid region of the non-dominant arm to participants in YA GSK4382276A Dose level 2 and OA GSK4382276A Selected Dose level from YA groups, at Day 1. Potential intermediate dose levels may be evaluated, with the total number of dose levels per age group not exceeding 5.
Intervention Type
Biological
Intervention Name(s)
GSK4382276A Dose level 3
Intervention Description
Dose level 3 of GSK4382276A is administered intramuscularly in the upper deltoid region of the non-dominant arm to participants in YA GSK4382276A Dose level 3 and OA GSK4382276A Selected Dose level from YA groups, at Day 1. Potential intermediate dose levels may be evaluated, with the total number of dose levels per age group not exceeding 5.
Intervention Type
Biological
Intervention Name(s)
GSK4382276A Dose level 4
Intervention Description
Dose level 4 of GSK4382276A is administered intramuscularly in the upper deltoid region of the non-dominant arm to participants in YA GSK4382276A level 4 and OA GSK4382276A Dose level 4 groups, at Day 1. Potential intermediate dose levels may be evaluated, with the total number of dose levels per age group not exceeding 5.
Intervention Type
Biological
Intervention Name(s)
GSK4382276A Dose level 6
Intervention Description
Dose level 6 of GSK4382276A is administered intramuscularly in the upper deltoid region of the non-dominant arm to participants in YA GSK4382276A level 6 group, at Day 1.
Intervention Type
Biological
Intervention Name(s)
GSK4382276A Dose level 7
Intervention Description
Dose level 7 of GSK4382276A is administered intramuscularly in the upper deltoid region of the non-dominant arm to participants in YA GSK4382276A level 7 group, at Day 1.
Intervention Type
Biological
Intervention Name(s)
GSK4382276A Dose level 8
Intervention Description
Dose level 8 of GSK4382276A is administered intramuscularly in the upper deltoid region of the non-dominant arm to participants in YA GSK4382276A level 8 group, at Day 1. Potential intermediate dose levels may be evaluated with the total number of dose levels not exceeding 10 in YA and 1 in OA.
Intervention Type
Biological
Intervention Name(s)
GSK4382276A Dose level 9
Intervention Description
Dose level 9 of GSK4382276A is administered intramuscularly in the upper deltoid region of the non-dominant arm to participants in YA GSK4382276A level 9 group, at Day 1. Potential intermediate dose levels may be evaluated with the total number of dose levels not exceeding 10 in YA and 1 in OA.
Intervention Type
Biological
Intervention Name(s)
GSK4382276A Dose level 10
Intervention Description
Dose level 10 of GSK4382276A is administered intramuscularly in the upper deltoid region of the non-dominant arm to participants in YA GSK4382276A level 10 group, at Day 1.
Intervention Type
Biological
Intervention Name(s)
GSK4382276A Dose level 11
Intervention Description
Dose level 11 of GSK4382276A is administered intramuscularly in the upper deltoid region of the non-dominant arm to participants in YA GSK4382276A level 11 group, at Day 1.
Intervention Type
Combination Product
Intervention Name(s)
FDQ21A-NH
Intervention Description
Single dose of FDQ21A-NH is administered intramuscularly in the upper deltoid region of the non-dominant arm to participants in YA Control 1 and OA Control groups, at Day 1.
Intervention Type
Combination Product
Intervention Name(s)
FDQ22A-NH
Intervention Description
Single dose of FDQ21A-NH is administered intramuscularly in the upper deltoid region of the non-dominant arm to participants in YA Control 2, at Day 1.
Primary Outcome Measure Information:
Title
Number of participants reporting each solicited administration site event
Description
The following administration site events will be solicited: pain, redness, swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm).
Time Frame
From Day 1 to Day 7
Title
Number of participants reporting each solicited systemic event
Description
The following systemic events will be solicited: fever, headache, myalgia, arthralgia, fatigue, chills. Fever is defined as temperature ≥38°C/100.4°F regardless the location of measurement. The preferred location for measuring temperature is axillary.
Time Frame
From Day 1 to Day 7
Title
Number of participants reporting unsolicited adverse events (AEs)
Description
An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Time Frame
From Day 1 to Day 28
Title
Number of participants reporting serious adverse events (SAEs)
Description
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or is an abnormal pregnancy outcome.
Time Frame
From Day 1 to Day 183
Title
Number of participants reporting adverse events of special interest (AESIs)
Description
The following events are considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs).
Time Frame
From Day 1 to Day 183
Title
Number of participants reporting a shift from non-clinically significant laboratory value on Day 1 to clinically significant abnormal laboratory value on Day 8 or on Day 29 for hematology, clinical chemistry, coagulation and urine analysis
Description
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition.
Time Frame
From Day 1 (pre-dose) to Day 8 (post-dose) or to Day 29 (post-dose)
Title
Geometric mean titers (GMT) of anti-vaccine antibody titers
Time Frame
At Day 1
Title
GMT of anti-vaccine antibody titers
Time Frame
At Day 22
Title
Geometric mean increase (GMI) of anti-vaccine antibody titers
Description
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titer over the Day 1 anti-vaccine antibody titer.
Time Frame
From Day 1 to Day 22
Title
Anti-vaccine antibody titers seroconversion rate (SCR)
Description
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer < 1:10 and a post-dose anti-vaccine antibody titer ≥ 1:40 or a pre-dose anti-vaccine antibody titer ≥ 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer.
Time Frame
From Day 1 to Day 22
Title
Anti-vaccine antibody seroprotection rate (SPR)
Description
SPR is defined as the percentage of dosed participants with an anti-vaccine antibody titer ≥ 1:40.
Time Frame
At Day 22
Secondary Outcome Measure Information:
Title
GMT of anti-vaccine antibody titer.
Time Frame
At Day 62 and Day 183
Title
GMI of anti-vaccine antibody titer
Description
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titer over the Day 1 anti-vaccine antibody titer.
Time Frame
From Day 1 to Day 62
Title
GMI of anti-vaccine antibody titer
Description
GMI is defined as the geometric mean of the ratios of the post-dose anti-vaccine antibody titer over the Day 1 anti-vaccine antibody titer.
Time Frame
From Day 1 to Day 183
Title
Anti-vaccine antibody titer SPR
Description
SPR is defined as the percentage of dosed participants with an anti-vaccine antibody titer ≥ 1:40.
Time Frame
At Day 62 and Day 183

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A male or female between and including 18 and 45 years of age (YAs) or between and including 60 and 80 years of age (OAs) at the time of the study intervention administration. The age of sentinel participants in OA category will be limited to maximum 70 years. Healthy or medically stable participants as established by medical history, safety laboratory assessments and clinical examination. Body mass index ≥ 18 kg/m^2 and ≤ 32 kg/m^2. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Written informed consent obtained from the participant prior to performing any study-specific procedure. Female participants of non-childbearing potential may be enrolled in the study. Female participants of childbearing potential may be enrolled in the study if the participant: has practiced adequate contraception for 28 days prior to study intervention administration, and has a negative pregnancy test on the day of study intervention administration, and has agreed to continue adequate contraception for at least 1 month after study intervention administration. Exclusion Criteria: Medical conditions Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or review of the participant's medical record. Any clinically significant* hematological coagulation or urine analysis laboratory abnormality. * The investigator should use his/her clinical judgement to decide which abnormalities are clinically significant. Current or past malignancy, unless completely resolved without sequelae for >5 years. Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, 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 study intervention (including latex, poly-ethylene-glycol, egg protein and aminoglycoside antibiotics). Recurrent history or uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell's palsy, with the exception of febrile seizures during childhood. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Significant exposure to persons with influenza or laboratory-confirmed SARS-CoV-2 within 7 days prior to Visit 1 (Day 1) and for whom a SARS-CoV-2 PCR test has not (yet) been confirmed as negative. Prior/Concomitant therapy Administration of seasonal influenza vaccine within 180 days before enrollment or planned administration up to Visit 4 (Day 29). Administration of a vaccine not foreseen by the study protocol in the period starting 28 days before the study intervention administration, or planned administration within 28 days after the study intervention administration*, with the exception of vaccines authorized or approved for the prevention of COVID-19 (regardless of the type of vaccine). *In case emergency mass vaccination for an unforeseen public health threat is organized by public health authorities outside the routine immunization program, the time period described above can be reduced to 7 days, if necessary, for that mass vaccination vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly. Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention during the period beginning 30 days before the study intervention administration, or their planned use during the study period. Administration of long-acting immune-modifying drugs within 90 days before enrollment or planned use 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 study intervention administration, or planned administration during the study period. Administration of monoclonal antibodies specifically directed against the spike protein of SARS-CoV-2 virus, for treatment of COVID-19 disease is allowed. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the study intervention administration. For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day. Inhaled, topical and intraarticular steroids are allowed. Previous enrolment in this study. Other exclusions Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period. History of abusive alcohol and/or drug consumption in the past 5 years. Any study personnel or their immediate dependents, family, or household members. Participants with extensive tattoos covering deltoid region on both arms that would preclude the assessment of local reactogenicity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
Facility Name
GSK Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3J 3G9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
Facility Name
GSK Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Individual Site Status
Completed
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
Facility Name
GSK Investigational Site
City
Majadahonda (Madrid)
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com

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, a 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

A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults

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