A Phase 1/2, Randomized, Controlled, Observer-blind, Multicentre Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of GSK Biologicals' Investigational Respiratory Syncytial Virus (RSV)/Human Metapneumovirus (hMPV) Combination and Investigational hMPV Vaccines When Administered Intramuscularly According to a Single Dose Schedule in Younger Adults ≥18 to ≤49 Years and Older Adults Aged ≥60 to ≤80 Years

GlaxoSmithKline

Summary

The aim of this study is to evaluate the safety, reactogenicity, and immune response of the different formulations of the investigational RSV/hMPV combination vaccine and investigational hMPV vaccine in younger and older adults.

Eligibility

Age range: 18–80 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Written informed consent obtained from the participant prior to performance of any study-specific procedure. * Participants who can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, ability to access and utilize a phone or other electronic communications). * Body Mass Index (BMI) between 18 kg/m\^2 and 33 kg/m\^2, inclusive. Specific inclusion criteria for OA * A male or female between and including, 60 to…

Interventions

Biological
RSV/hMPV_V low dose vaccine
RSV/hMPV\_V low dose vaccine administered intramuscularly.
Biological
RSV/hMPV_V medium dose vaccine
RSV/hMPV\_V medium dose vaccine administered intramuscularly.
Biological
RSV/hMPV_V high dose vaccine
RSV/hMPV\_V high dose vaccine administered intramuscularly.
Biological
RSV/hMPV_W low dose vaccine
RSV/hMPV\_W low dose vaccine administered intramuscularly.
Biological
RSV/hMPV_W medium dose vaccine
RSV/hMPV\_W medium dose vaccine administered intramuscularly.
Biological
RSV/hMPV_W high dose vaccine
RSV/hMPV\_W high dose vaccine administered intramuscularly.
Biological
RSV/hMPV_X low dose vaccine
RSV/hMPV\_X low dose vaccine administered intramuscularly.
Biological
RSV/hMPV_X medium dose vaccine
RSV/hMPV\_X medium dose vaccine administered intramuscularly.
Biological
RSV/hMPV_X high dose vaccine
RSV/hMPV\_X high dose vaccine administered intramuscularly.
Biological
hMPV_Y low dose vaccine
hMPV\_Y low dose vaccine administered intramuscularly.
Biological
hMPV_Y medium dose vaccine
hMPV\_Y medium dose vaccine administered intramuscularly.
Biological
hMPV_Y high dose vaccine
hMPV\_Y high dose vaccine administered intramuscularly.
Biological
hMPV_Z low dose vaccine
hMPV\_Z low dose vaccine administered intramuscularly.
Biological
hMPV_Z medium dose vaccine
hMPV\_Z medium dose vaccine administered intramuscularly.
Biological
hMPV_Z high dose vaccine
hMPV\_Z high dose vaccine administered intramuscularly.
Biological
Control vaccine
Control vaccine administered intramuscularly.
Combination Product
Placebo
Placebo administered intramuscularly.

Summary

Eligibility

Interventions

Locations (4)