RSV-MAT-004
Research type
Research Study
Full title
A Phase II, randomised, observer-blind, placebo controlled multi-country study to assess the safety, reactogenicity and immunogenicity of a single intramuscular dose of GSK Biologicals’ investigational RSV Maternal unadjuvanted vaccine (GSK3888550A), in healthy pregnant women aged 18 to 40 years and infants born to vaccinated mothers
IRAS ID
272527
Contact name
Asma Khalil
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2019-001991-12
Duration of Study in the UK
1 years, 6 months, 3 days
Research summary
Respiratory Syncytial Virus (RSV) is a germ that can cause infections of the airways. Whilst most infections of RSV present as a simple cold, in young babies RSV can cause difficulty in breathing and can be dangerous. RSV infection is one of the most common reasons for young babies to be admitted to hospital.
For protection against RSV, babies depend on antibodies given to them from their mothers during pregnancy. A vaccine is one way to increase the antibodies in pregnant women.
This study, funded by GlaxoSmithKline, will assess the safety of the RSV vaccine in pregnant women and their babies. It will look at: how well the vaccine can boost antibodies in pregnant women; how well the antibodies are passed from the pregnant woman to their babies; and how long the antibodies stay in the babies’ blood.
This is the first study in which pregnant women will receive this vaccine. Only women aged 18 to 40 years, with uncomplicated pregnancies will be included. Participants will be put into one of 3 study groups: small dose; large dose; or placebo (a dummy vaccine). All will receive a single injection into the muscle between weeks 28 and 33 of pregnancy, and will be followed for 6 months after delivery. Babies will be followed for 12 months after birth.
Mothers will have: about 9 planned visits; a general and obstetrical examination; their body temperature measured; blood and urine collected; and completion of an eDiary.
Babies will have: about 5 planned visits; a physical examination; blood collected from the umbilical cord and arm.
Safety will be monitored for mothers and babies. They may also have extra visits for cold-like illnesses, where nasal swabs will be collected.
The study will include 150 subjects worldwide. Four hospitals in the UK will take part.REC name
London - Brent Research Ethics Committee
REC reference
19/LO/1790
Date of REC Opinion
5 Feb 2020
REC opinion
Further Information Favourable Opinion