A study of investigational RSV/hMPV combination and investigational hMPV vaccines in older adults
Research type
Research Study
Full title
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
IRAS ID
1013499
Contact name
n/a n/a
Contact email
Sponsor organisation
GlaxoSmithKline Biologicals SA
Eudract number
2025-524456-58
Clinicaltrials.gov Identifier
Research summary
This first-time-in-human (FTiH) clinical study, funded by GlaxoSmithKline Biologicals SA, is testing new vaccines against Respiratory Syncytial Virus (RSV) and/or Human Metapneumovirus (hMPV), two common respiratory viruses. These viruses can cause severe lung infections, particularly in older adults and people with chronic medical conditions, and currently, there is no hMPV vaccine available.
The study aims to evaluate the vaccines' safety, side effects (reactogenicity), and their ability to trigger an immune response (immunogenicity). Participants, including younger adults (18-49) and older adults (60-80), will receive a single injection of either an investigational vaccine, an RSV vaccine or a placebo (an inactive dummy treatment). Treatments are assigned randomly, and the study is "observer-blind," meaning participants and some site staff won’t know which treatment is being administered, to ensure uninfluenced study conduct.
Participant involvement includes a single injection, followed by study visits and contacts for up to 24 months. This involves medical check-ups, blood samples for analysis, and recording symptoms in an electronic diary (eDiary). While immediate personal health benefits from the new vaccines are not guaranteed, participants receive health monitoring and contribute crucial information for developing future preventive treatments. Since this is the first time these vaccines are being administered to humans, common vaccine side effects like injection site pain, fatigue, headache, and muscle aches might occur, but there is currently not enough information available to fully predict all potential adverse events (side effects).
The research is recruiting in multiple international centres, including the UK.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
26/SC/0092
Date of REC Opinion
9 Jul 2026
REC opinion
Further Information Favourable Opinion