GEMINI D8610C00001
Research type
Research Study
Full title
A Phase 3, Global, Randomized, Modified Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of IVX-A12, a Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (hMPV) Virus-Like Particle (VLP) Vaccine, in Adults 60 Years of Age and Older
IRAS ID
1010431
Contact name
n/a n/a
Contact email
Sponsor organisation
Astra Zeneca AB
Research summary
This a Phase 3 study to learn more about the safety, immune response and efficacy of the investigational vaccine called IVX-A12. IVX-A12 is being developed to prevent disease caused by two respiratory viruses, called respiratory syncytial virus (RSV) and human metapneumovirus (hMPV), in adults who are at least 60 years old.
RSV and the closely related hMPV are two viral pathogens (germs) that are present throughout the year but are seen more frequently during the colder seasons. A person’s immune system becomes less effective at fighting infections as they get older, which means respiratory illnesses can more often lead to hospitalisation or even death. RSV and hMPV contribute to a large number of hospitalisations for viral lung infections particularly in older adults. This study will look to investigate a potential combination vaccine for the protection against respiratory diseases caused by RSV and hMPV.
IVX-A12 will be compared with placebo, a substance that does not contain any medicinal/active ingredients. IVX-A12 and placebo will be given as an injection (jab).
The patient will be in the study for approximately 24 months (2 years) following administration of the first dose of VX-A12 or placebo. About 30,000 people globally will take part in this study.
This study is conducted by Icosavax, a company that discovers and makes vaccines and other healthcare products.
REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0650
Date of REC Opinion
18 Oct 2024
REC opinion
Further Information Favourable Opinion