Multivalent Group B Streptococcus Vaccine in Healthy Women and Infants
Research type
Research Study
Full title
A phase 1/2, randomized, placebo-controlled, observer-blinded trial to evaluate the safety, tolerability, and immunogenicity of a multivalent group b streptococcus vaccine in healthy nonpregnant women and pregnant women 18 to 40 years of age and their infants
IRAS ID
294701
Contact name
Raphael Simon
Contact email
Sponsor organisation
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eudract number
2020-005074-96
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 26 days
Research summary
Group B streptococcus (GBS) is the most common cause of serious bacterial infections in young babies and of meningitis in infants in the UK and a significant cause of infant morbidity and mortality globally.
Vaccination of pregnant women has been used globally in the prevention of neonatal tetanus and more recently for prevention of pertussis in young infants, and to protect women and their infants against influenza. Pfizer is developing a 6-valent capsular polysaccharide (CPS) conjugate vaccine (group B streptococcus 6-valent polysaccharide conjugate vaccine [GBS6]) aimed at the prevention of group B streptococcal disease due to 6 types of GBS in young infants by active immunisation of pregnant women. This Phase 1/2, randomised, placebo-controlled, observer-blinded study will be the first evaluation of the investigational GBS6 in pregnant women.
The study is split into 3 stages. The UK will take part in stage 3 only. This application form will be based on stage 3, and only refer briefly to stage 1 and 2.
REC name
London - Brent Research Ethics Committee
REC reference
21/LO/0240
Date of REC Opinion
2 Jun 2021
REC opinion
Further Information Favourable Opinion