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
Open to recruitment
Aim of the study
This phase 3 study aims to further understand the safety, tolerability and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in healthy pregnant women.
The role of this placebo-controlled study is to provide more robust information on the vaccine immune response in pregnancy, as well as safety reporting and the potential transfer of maternal antibodies to infants.
Inclusion and exclusion criteria
Healthy women over 18 years old who are pregnant and expecting one child can participate. Participants should be about 24-34 weeks (6-8 months) pregnant when they receive the study injection and should not have been previously diagnosed with COVID-19.
What participating in the study involves?
Each participant enrolled in the study will initially receive either two doses of the vaccine or a placebo 21 days apart. All participants will be unblinded one-month post pregnancy, and those who were given the placebo jab (a salt water solution that does not contain any active ingredients) will receive the Pfizer-BioNTech COVID-19 vaccine.
Research participants will be required to answer questionnaires about their health, provide blood samples, complete an e-diary and will receive extra monitoring while on the study, compared to those who receive a vaccine through the rollout.
If enrolled, you will have 4 planned visits at the study site before your baby is born and 2 visits after your baby is born.
- The first 2 visits are when you receive the study vaccine or placebo through an injection in your arm. These visits are about 3 weeks apart.
- After you receive your injections, you will be asked to record any changes to your health and have follow up visits.
- At the one month follow up visit after your baby is born, you will learn if you received the placebo or the active study vaccine (called unblinding) while you were pregnant. Participants who received the placebo will then receive their first dose of the active study vaccine.
- Your time in the study will last for about 7-10 months, and your baby will also have a follow-up visit when they are about 6 months old.