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

PHASE1CompletedINTERVENTIONAL
Enrollment

324

Participants

Timeline

Start Date

August 9, 2022

Primary Completion Date

March 26, 2024

Study Completion Date

March 26, 2024

Conditions
Influenza, Human
Interventions
BIOLOGICAL

GSK4382276A Dose level 1

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.

BIOLOGICAL

GSK4382276A Dose level 2

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.

BIOLOGICAL

GSK4382276A Dose level 3

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.

BIOLOGICAL

GSK4382276A Dose level 4

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.

BIOLOGICAL

GSK4382276A Dose level 6

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.

BIOLOGICAL

GSK4382276A Dose level 7

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.

BIOLOGICAL

GSK4382276A Dose level 8

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.

BIOLOGICAL

GSK4382276A Dose level 9

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.

BIOLOGICAL

GSK4382276A Dose level 10

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.

BIOLOGICAL

GSK4382276A Dose level 11

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.

COMBINATION_PRODUCT

FDQ21A-NH

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.

COMBINATION_PRODUCT

FDQ22A-NH

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.

Trial Locations (7)

2650

GSK Investigational Site, Edegem

9000

GSK Investigational Site, Ghent

28006

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28222

GSK Investigational Site, Madrid

B3J 3G9

GSK Investigational Site, Halifax

J1L 0H8

GSK Investigational Site, Sherbrooke

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

CureVac

INDUSTRY

lead

GlaxoSmithKline

INDUSTRY

NCT05446740 - A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults | Biotech Hunter | Biotech Hunter