324
Participants
Start Date
August 9, 2022
Primary Completion Date
March 26, 2024
Study Completion Date
March 26, 2024
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
GSK Investigational Site, Edegem
GSK Investigational Site, Ghent
GSK Investigational Site, Madrid
GSK Investigational Site, Madrid
GSK Investigational Site, Madrid
GSK Investigational Site, Halifax
GSK Investigational Site, Sherbrooke
Lead Sponsor
Collaborators (1)
CureVac
INDUSTRY
GlaxoSmithKline
INDUSTRY