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A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults

Primary Purpose

Influenza, Human

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Flu mRNA
Control 1
Control 2
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 - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: A male or female between and including 18 and 50 years of age in Phase 1 and between and including 18 and 85 years of age (YA: 18-64; OA: 65-85) in Phase 2 at the time of the study intervention administration. Healthy participants or medically stable participants as established by medical history, clinical examination and safety laboratory assessments. Participants with chronic medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment. Body mass index (BMI) >=18 kilograms per meter square (kg/m^2) and less than or equal to (<=) 35 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 Only in Phase 1: Any clinically significant* hematological, biochemical, urinalysis or (hemoglobin A1c) HbA1c laboratory abnormality. *The investigator should use the clinical judgment to decide which abnormalities are clinically significant. Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1. Current or past malignancy, unless completely resolved without clinically significant 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). However, in Phase 2, HIV-infected individuals may be enrolled if participants have been stable on antiretroviral therapy for the past 6 consecutive months, i.e., their treatment has not been modified, their cluster of differentiation 4 (CD4) cell count is >=200/cubic millimeter (mm^3) and their viral load has been undetectable (i.e., HIV-RNA less than (<) 50 copies/milliliter [mL]) (based on medical records, no laboratory testing required). History of myocarditis or pericarditis less than or equal to 10 years prior to vaccine administration, including a history of myocarditis or pericarditis following vaccination with an mRNA coronavirus disease 2019 (COVID-19) vaccine. Participants with history of hypersensitivity or severe allergic reaction to any previous vaccine or hypersensitivity likely to be exacerbated by any component of the study intervention (including latex, polyethylene glycol, egg protein and aminoglycoside antibiotics). History of, or uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell's palsy, with the exception of febrile seizures during childhood. Any history of dementia or any medical condition that moderately or severely impairs cognition. 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. Prior/Concomitant therapy Administration of an influenza vaccine (including any of the study investigational vaccines) within 180 days before enrollment or planned administration within 28 days (Day 29) after the study intervention administration. Administration of a vaccine not foreseen by the study protocol in the period starting 28 days (Day -28) before the study intervention administration, or planned administration within 28 days (Day 29) after the study intervention administration*. *In case emergency mass vaccination for an unforeseen public health threat is recommended and/or 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 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 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), 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 milligrams (mg)/day. Inhaled, topical and intraarticular steroids are allowed. Other exclusions 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 intervention (drug/invasive medical device). Pregnant or lactating female. Bedridden participants. Female planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period. Alcoholism or substance use disorder within the past 24 months based on the presence of 2 or more of the following abuse criteria: hazardous use, social/interpersonal problems related to use, neglect of major roles to use, withdrawal, tolerance, use of larger amounts or longer, repeated attempts to quit or control use, much time spent using, physical or psychological problems related to use, activities given up to use, craving. 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 Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK investigational Site

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 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Experimental

Experimental

Experimental

Active Comparator

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Flu mRNA_1_1 Group

Flu mRNA_1_2 Group

Flu mRNA_1_3 Group

Flu mRNA_1_4 Group

Flu mRNA_1_5 Group

Flu mRNA_1_6 Group

Flu mRNA_1_7 Group

Flu mRNA_1_8 Group

Flu mRNA_1_9 Group

Flu mRNA_1_10 Group

Flu mRNA_1_11 Group

Flu mRNA_1_12 Group

Control Group

Formulation 1 based on Phase 1 data - YA Group

Formulation 2 based on Phase 1 data - YA Group

Formulation 3 based on Phase 1 data - YA Group

Control YA Group

Formulation 4 based on Phase 1 data -OA Group

Formulation 5 based on Phase 1 data -OA Group

Formulation 6 based on Phase 1 data -OA Group

Control OA Group

Arm Description

Eligible Younger Adults (YA) participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 1 administered in Phase 1, at Day 1.

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 2 administered in Phase 1, at Day 1.

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 3 administered in Phase 1, at Day 1.

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 4 administered in Phase 1, at Day 1.

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 5 administered in Phase 1, at Day 1.

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 6 administered in Phase 1, at Day 1.

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 7 administered in Phase 1, at Day 1.

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 8 administered in Phase 1, at Day 1.

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 9 administered in Phase 1, at Day 1.

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 10 administered in Phase 1, at Day 1.

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 11 administered in Phase 1, at Day 1.

Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 12 administered in Phase 1, at Day 1.

Eligible YA participants receive a single dose of Control 1 administered in Phase 1, at Day 1.

Eligible YA participants receive a single dose of selected formulation 1 based on Phase 1 of Flu mRNA - study intervention administered in Phase 2, at Day 1.

Eligible YA participants receive a single dose of selected formulation 2 based on Phase 1 of Flu mRNA - study intervention administered in Phase 2, at Day 1.

Eligible YA participants receive single dose of selected formulation 3 based on Phase 1 of Flu mRNA - study intervention administered in Phase 2, at Day 1.

Eligible YA participants receive single dose of Control 1 vaccine administered in Phase 2, at Day 1

Eligible OA participants receive a single dose of selected formulation 4 based on Phase 1 of Flu mRNA - study intervention administered in Phase 2, at Day 1.

Eligible OA participants receive single dose of selected formulation 5 based on Phase 1 of Flu mRNA - study intervention administered in Phase 2, at Day 1.

Eligible OA participants receive single dose of selected formulation 6 based on Phase 1 of Flu mRNA - study intervention administered in Phase 2, at Day 1.

Eligible OA participants receive a single dose of Control 2 vaccine administered in Phase 2, at Day 1.

Outcomes

Primary Outcome Measures

Percentage 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).
Percentage 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 greater than or equal to (>=) 38 degree Celsius (°C)/100.4 degree Fahrenheit (°F) regardless the location of measurement. The route for measuring temperature can be oral, axillary or tympanic.
Percentage of participants reporting unsolicited adverse events (AEs)
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs.
Percentage 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 persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product.
Percentage 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).
Percentage of participants reporting medically attended events (MAEs)
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization).
Percentage of participants reporting a shift from a non-clinically significant laboratory value on Day 1 (pre-dose) to a clinically significant abnormal laboratory value on Day 8 (post-dose) and/or Day 29 (post-dose) for hematology and clinical chemistry
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 titer (GMT) of antigen 1 antibody titer
Geometric mean increase (GMI) of antigen 1 antibody titer
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.
Percentage of participants with antigen 1 seroconversion rate (SCR)
Percentage of participants with antigen 1 titer >= cut off value
GMT of antigen 2 antibody titer
GMI of antigen 2 antibody titer
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.
Percentage of participants with antigen 2 SCR

Secondary Outcome Measures

GMT of antigen 1 antibody titer
GMI of antigen 1 antibody titer
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.
GMI of antigen 1 antibody titer
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.
Percentage of participants with antigen 1 titer >= cut off value
GMT of antigen 2 antibody titer
GMI of antigen 2 antibody titer
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.
GMI of antigen 2 antibody titer
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.

Full Information

First Posted
April 11, 2023
Last Updated
July 14, 2023
Sponsor
GlaxoSmithKline
Collaborators
CureVac
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1. Study Identification

Unique Protocol Identification Number
NCT05823974
Brief Title
A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults
Official Title
A Phase 1/2, Randomized, Dose-finding/Dose-confirmation Study to Evaluate the Reactogenicity, Safety and Immunogenicity of mRNA-based Multivalent Seasonal Influenza Vaccine Candidates Administered in Healthy Younger and Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
July 5, 2024 (Anticipated)
Study Completion Date
July 5, 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
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to find and confirm the dose and asses the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A) candidates administered in healthy younger 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, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Phase 2 of this study will be observer blind.
Allocation
Randomized
Enrollment
293 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flu mRNA_1_1 Group
Arm Type
Experimental
Arm Description
Eligible Younger Adults (YA) participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 1 administered in Phase 1, at Day 1.
Arm Title
Flu mRNA_1_2 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 2 administered in Phase 1, at Day 1.
Arm Title
Flu mRNA_1_3 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 3 administered in Phase 1, at Day 1.
Arm Title
Flu mRNA_1_4 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 4 administered in Phase 1, at Day 1.
Arm Title
Flu mRNA_1_5 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 5 administered in Phase 1, at Day 1.
Arm Title
Flu mRNA_1_6 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 6 administered in Phase 1, at Day 1.
Arm Title
Flu mRNA_1_7 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 7 administered in Phase 1, at Day 1.
Arm Title
Flu mRNA_1_8 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 8 administered in Phase 1, at Day 1.
Arm Title
Flu mRNA_1_9 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 9 administered in Phase 1, at Day 1.
Arm Title
Flu mRNA_1_10 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 10 administered in Phase 1, at Day 1.
Arm Title
Flu mRNA_1_11 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 11 administered in Phase 1, at Day 1.
Arm Title
Flu mRNA_1_12 Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 12 administered in Phase 1, at Day 1.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Eligible YA participants receive a single dose of Control 1 administered in Phase 1, at Day 1.
Arm Title
Formulation 1 based on Phase 1 data - YA Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive a single dose of selected formulation 1 based on Phase 1 of Flu mRNA - study intervention administered in Phase 2, at Day 1.
Arm Title
Formulation 2 based on Phase 1 data - YA Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive a single dose of selected formulation 2 based on Phase 1 of Flu mRNA - study intervention administered in Phase 2, at Day 1.
Arm Title
Formulation 3 based on Phase 1 data - YA Group
Arm Type
Experimental
Arm Description
Eligible YA participants receive single dose of selected formulation 3 based on Phase 1 of Flu mRNA - study intervention administered in Phase 2, at Day 1.
Arm Title
Control YA Group
Arm Type
Active Comparator
Arm Description
Eligible YA participants receive single dose of Control 1 vaccine administered in Phase 2, at Day 1
Arm Title
Formulation 4 based on Phase 1 data -OA Group
Arm Type
Experimental
Arm Description
Eligible OA participants receive a single dose of selected formulation 4 based on Phase 1 of Flu mRNA - study intervention administered in Phase 2, at Day 1.
Arm Title
Formulation 5 based on Phase 1 data -OA Group
Arm Type
Experimental
Arm Description
Eligible OA participants receive single dose of selected formulation 5 based on Phase 1 of Flu mRNA - study intervention administered in Phase 2, at Day 1.
Arm Title
Formulation 6 based on Phase 1 data -OA Group
Arm Type
Experimental
Arm Description
Eligible OA participants receive single dose of selected formulation 6 based on Phase 1 of Flu mRNA - study intervention administered in Phase 2, at Day 1.
Arm Title
Control OA Group
Arm Type
Active Comparator
Arm Description
Eligible OA participants receive a single dose of Control 2 vaccine administered in Phase 2, at Day 1.
Intervention Type
Biological
Intervention Name(s)
Flu mRNA
Other Intervention Name(s)
GSK4382276A
Intervention Description
Different formulations of Flu mRNA (GSK4382276A) study intervention is administered intramuscularly in the non-dominant upper deltoid to YA and OA participants in Phase 1 and Phase 2, at Day 1.
Intervention Type
Combination Product
Intervention Name(s)
Control 1
Intervention Description
Control 1 vaccine is administered intramuscularly in the non-dominant upper deltoid to participants in Control group from Phase 1, at Day 1 and to participants in Control YA group from Phase 2, at Day 1.
Intervention Type
Combination Product
Intervention Name(s)
Control 2
Intervention Description
Control 2 vaccine is administered intramuscularly in the non-dominant upper deltoid to participants in Control OA group from Phase 2, at Day 1.
Primary Outcome Measure Information:
Title
Percentage 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
Percentage 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 greater than or equal to (>=) 38 degree Celsius (°C)/100.4 degree Fahrenheit (°F) regardless the location of measurement. The route for measuring temperature can be oral, axillary or tympanic.
Time Frame
From Day 1 to Day 7
Title
Percentage of participants reporting unsolicited adverse events (AEs)
Description
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs.
Time Frame
From Day 1 to Day 28
Title
Percentage 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 persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product.
Time Frame
From Day 1 to Day 183
Title
Percentage 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
Percentage of participants reporting medically attended events (MAEs)
Description
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization).
Time Frame
From Day 1 to Day 183
Title
Percentage of participants reporting a shift from a non-clinically significant laboratory value on Day 1 (pre-dose) to a clinically significant abnormal laboratory value on Day 8 (post-dose) and/or Day 29 (post-dose) for hematology and clinical chemistry
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) and/or Day 29 (post-dose)
Title
Geometric mean titer (GMT) of antigen 1 antibody titer
Time Frame
At Day 29
Title
Geometric mean increase (GMI) of antigen 1 antibody titer
Description
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.
Time Frame
From Day 1 to Day 29
Title
Percentage of participants with antigen 1 seroconversion rate (SCR)
Time Frame
From Day 1 to Day 29
Title
Percentage of participants with antigen 1 titer >= cut off value
Time Frame
At Day 1 and Day 29
Title
GMT of antigen 2 antibody titer
Time Frame
At Day 29
Title
GMI of antigen 2 antibody titer
Description
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.
Time Frame
From Day 1 to Day 29
Title
Percentage of participants with antigen 2 SCR
Time Frame
From Day 1 to Day 29
Secondary Outcome Measure Information:
Title
GMT of antigen 1 antibody titer
Time Frame
At Day 92 and Day 183
Title
GMI of antigen 1 antibody titer
Description
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.
Time Frame
From Day 1 to Day 92
Title
GMI of antigen 1 antibody titer
Description
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.
Time Frame
From Day 1 to Day 183
Title
Percentage of participants with antigen 1 titer >= cut off value
Time Frame
At Day 183
Title
GMT of antigen 2 antibody titer
Time Frame
At Day 92 and Day 183
Title
GMI of antigen 2 antibody titer
Description
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.
Time Frame
From Day 1 to Day 92
Title
GMI of antigen 2 antibody titer
Description
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer.
Time Frame
From Day 1 to Day 183

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A male or female between and including 18 and 50 years of age in Phase 1 and between and including 18 and 85 years of age (YA: 18-64; OA: 65-85) in Phase 2 at the time of the study intervention administration. Healthy participants or medically stable participants as established by medical history, clinical examination and safety laboratory assessments. Participants with chronic medical conditions with or without specific treatment are allowed to participate in this study if considered by the investigator as medically stable. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrollment. Body mass index (BMI) >=18 kilograms per meter square (kg/m^2) and less than or equal to (<=) 35 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 Only in Phase 1: Any clinically significant* hematological, biochemical, urinalysis or (hemoglobin A1c) HbA1c laboratory abnormality. *The investigator should use the clinical judgment to decide which abnormalities are clinically significant. Participant tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1. Current or past malignancy, unless completely resolved without clinically significant 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). However, in Phase 2, HIV-infected individuals may be enrolled if participants have been stable on antiretroviral therapy for the past 6 consecutive months, i.e., their treatment has not been modified, their cluster of differentiation 4 (CD4) cell count is >=200/cubic millimeter (mm^3) and their viral load has been undetectable (i.e., HIV-RNA less than (<) 50 copies/milliliter [mL]) (based on medical records, no laboratory testing required). History of myocarditis or pericarditis less than or equal to 10 years prior to vaccine administration, including a history of myocarditis or pericarditis following vaccination with an mRNA coronavirus disease 2019 (COVID-19) vaccine. Participants with history of hypersensitivity or severe allergic reaction to any previous vaccine or hypersensitivity likely to be exacerbated by any component of the study intervention (including latex, polyethylene glycol, egg protein and aminoglycoside antibiotics). History of, or uncontrolled neurological disorders or seizures, including Guillain-Barré syndrome and Bell's palsy, with the exception of febrile seizures during childhood. Any history of dementia or any medical condition that moderately or severely impairs cognition. 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. Prior/Concomitant therapy Administration of an influenza vaccine (including any of the study investigational vaccines) within 180 days before enrollment or planned administration within 28 days (Day 29) after the study intervention administration. Administration of a vaccine not foreseen by the study protocol in the period starting 28 days (Day -28) before the study intervention administration, or planned administration within 28 days (Day 29) after the study intervention administration*. *In case emergency mass vaccination for an unforeseen public health threat is recommended and/or 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 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 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), 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 milligrams (mg)/day. Inhaled, topical and intraarticular steroids are allowed. Other exclusions 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 intervention (drug/invasive medical device). Pregnant or lactating female. Bedridden participants. Female planning to become pregnant or planning to discontinue contraceptive precautions within the 1-month post-dosing period. Alcoholism or substance use disorder within the past 24 months based on the presence of 2 or more of the following abuse criteria: hazardous use, social/interpersonal problems related to use, neglect of major roles to use, withdrawal, tolerance, use of larger amounts or longer, repeated attempts to quit or control use, much time spent using, physical or psychological problems related to use, activities given up to use, craving. 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.
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
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
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
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
GSK Investigational Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
GSK Investigational Site
City
Wilrijk
State/Province
Antwerp
ZIP/Postal Code
2610
Country
Belgium
Facility Name
GSK investigational Site
City
Ghent
State/Province
Flemish
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD Sharing Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD Sharing Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
IPD Sharing URL
https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Learn more about this trial

A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults

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