RSV-F-004 - RSV Vaccine in Healthy Pregnant Women and their Infants
Research type
Research Study
Full title
A Phase I/II, randomised, observer-blind, controlled multi-country study to assess the safety, reactogenicity and immunogenicity of a single intramuscular dose of GSK Biologicals’ investigational RSV vaccine (GSK3003891A), in healthy pregnant women aged 18 to 40 years and infants born to vaccinated mothers
IRAS ID
217857
Contact name
Asma Khalil
Contact email
Sponsor organisation
GlaxoSmithKline UK Ltd
Eudract number
2016-002733-30
Duration of Study in the UK
3 years, 7 months, 10 days
Research summary
RSV Vaccine in Healthy Pregnant Women and their Infants.
Respiratory Syncytial Virus (RSV) is a germ that can cause infections of the airways. Whilst most infections just 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 hospital admissions in babies with an estimated 3 out of 100 babies under 6 months of age requiring hospitalisation.
It is hoped that by vaccinating pregnant women with an RSV vaccine, the antibodies that the mother will produce will protect the baby against RSV in the first few months after birth.
This study, funded by GlaxoSmithKline, will assess the safety of the RSV vaccine in pregnant women and their babies. It will also look at the immune response following vaccination and how well the antibodies are passed from the pregnant women to their unborn babies, and how long the antibodies stay in the babies’ blood.
This is the first study that pregnant women will receive this vaccine. Therefore, only women aged 18 to 40 years, with uncomplicated pregnancies will be included. Subjects will be vaccinated in between weeks 28 and 33 and will be followed up to 6 months after delivery. The infants will be followed for 2 years. Potential RSV infection will be monitored in the mothers and infants throughout the study.
The study will enrol 500 subjects worldwide with three hospital centres in the UK. Subjects have a 60% chance of receiving the RSV vaccine (300 subjects will receive one of three doses of the RSV vaccine and 200 subjects will receive placebo). The study will recruit in two steps: Step 1 will recruit 75 patients, Step 2 will recruit 425 patients. The data from Step 1 will be analysed prior to Step 2 starting.
REC name
London - Central Research Ethics Committee
REC reference
17/LO/0301
Date of REC Opinion
28 Feb 2017
REC opinion
Favourable Opinion