SARS-COV-2(BNT162b2) VACCINE AGAINST COVID-19 IN HEALTH PREGNANT WOMEN [COVID-19] [UPH]
Research type
Research Study
Full title
A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN HEALTHY PREGNANT WOMEN 18 YEARS OF AGE AND OLDER
IRAS ID
295903
Contact name
Christine Jones
Contact email
Sponsor organisation
BioNTech SE
Eudract number
2020-005444-35
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The Coronavirus (COVID-19) is a new respiratory disease that has rapidly spread around the world. COVID-19 is a worldwide pandemic and has effected all ages, gender and race. The Sponsor has decided to do this study to see the effects of the COVID-19 investigational vaccine on pregnant women. The study will be open to healthy women over the age of 18 years old who are expecting healthy babies. There will be 4000 healthy women and their unborn babies taking part in this study worldwide. This study is hugely important to the public as COVID-19 has had a massive impact on the world. It is hoped that with the vaccine this will help eliminate the virus. Pregnant women and their babies would be at a greater risk of COVID-19 however with the help of a vaccine this could prevent them getting the virus and thus getting very sick.
The vaccine helps your body produce antibodies to help fight off COVID-19. This is a randomized study. There is two groups, one group will receive 2 doses of the COVID-19 vaccine and the other group will receive 2 doses of the placebo. Once the study is over the participant will be informed of whether they received the placebo or vaccine. If they received the placebo they will be offered the vaccine. The participants will be in the study for 7 to 10 months. The length of time will depend if the participant was given the placebo or vaccine when taking part in the study. The participant’s baby will also be in the study for 6 months (to have a 6 month checkup). All women will have 6 study visits in total. (4 before the baby is born and 2 after).
In the UK public hospitals will be conducting the study.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
21/YH/0071
Date of REC Opinion
16 Apr 2021
REC opinion
Further Information Favourable Opinion