RSV Vaccine in Pregnancy
Research type
Research Study
Full title
A PHASE 3, RANDOMIZED, OBSERVER-BLIND, PLACEBO-CONTROLLED, GROUP-SEQUENTIAL STUDY TO DETERMINE THE IMMUNOGENICITY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) F NANOPARTICLE VACCINE WITH ALUMINUM IN HEALTHY THIRD-TRIMESTER PREGNANT WOMEN; AND SAFETY AND EFFICACY OF MATERNALLY TRANSFERRED ANTIBODIES IN PREVENTING RSV DISEASE IN THEIR INFANTS
IRAS ID
208946
Contact name
Paul Heath
Contact email
Sponsor organisation
Novavax, Inc.
Eudract number
2016-002302-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Respiratory syncytial virus (RSV) is a virus causing lung disease. This can be particularly serious in babies and can lead to hospital admission and occasionally death. One strategy to protect very young infants is to vaccinate women when they are pregnant which results in an increased amount of antibody being transferred to the infant through the placenta providing protection from the moment of birth. This strategy has been effectively used in the case of tetanus, influenza and pertussis (whooping cough).
This phase 3 randomised, observer-blind, placebo controlled study is being conducted to assess the efficacy and the safety of a new vaccine against RSV disease in infants. This is a multi-national study sponsored by Novavax and is planned to take place in 4 UK sites.
This study will recruit pregnant women between 28 and 36 weeks gestation who will be asked to consent for themselves and their baby. The participant will be randomly assigned (assigned by chance) to one of two groups to receive either the active vaccine or a placebo (a medication with no active ingredients). Following this, women will be asked to complete a symptom diary daily for seven days.
The study will last between 7 and 9 months for women (depending on their gestation at enrolment and delivery) and for 12 months for the infants. Women will be physically examined at the beginning of the study and if there are any concerns thereafter. Babies will have regular physical examinations. The study also involves blood tests: about 5 for women and up to 2 for infants, with additional cord sample at delivery. Women will be phoned weekly to screen for symptoms of RSV infection in them or their infants and will, where necessary, be reviewed by a member of the study team who may sample their upper airway secretions.REC name
London - Central Research Ethics Committee
REC reference
16/LO/1322
Date of REC Opinion
6 Sep 2016
REC opinion
Further Information Favourable Opinion