This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose given during a previous pregnancy by examining the blood of nonpregnant participants who had the vaccine before.
This study will include pregnant participants and their unborn babies (Cohort 1 and Cohort 2) and non-pregnant participants (Cohort 3), as described below: * Cohort 1- Pregnant participants who had previously received RSVpreF as part of a Pfizer clinical trial and have antibody data available from that trial will get a second dose of RSVpreF. * Cohort 2- Pregnant participants who received the RSVpreF in a previous pregnancy, either through commercial means with Abrysvo® or as part of a Pfizer clinical trial, will be randomly chosen to get either one dose of the RSVpreF or one dose of a placebo. This applies to those who do not have antibody data available from the earlier trial. For both groups of pregnant participants, the study will look at how safe and well-tolerated the vaccine is during pregnancy, as well as how the body responds to it. Infants will be monitored for six months after birth to check safety and antibodies level. • Cohort 3- Nonpregnant participants who received RSVpreF during a previous pregnancy as part of an earlier clinical trial will have blood samples taken to see how well their immune response has persisted over time. Participants will not receive any vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
550
Percentage of pregnant participants reporting local reactions
Pain at the injection site, redness, and swelling
Time frame: From Day 1 Through at least Day 7 after Vaccination
Percentage of pregnant participants reporting systemic events
Fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain
Time frame: From Day 1 Through at least Day 7 after Vaccination
Percentage of pregnant participants reporting adverse events
Time frame: From Day 1 through 4 weeks after vaccination
Percentage of pregnant participants reporting serious adverse events
Time frame: From Day 1 throughout the study
In infant participants born to pregnant participants receiving a second dose of the study intervention, the percentage of participants reporting adverse events.
Time frame: From birth through 1 month of age
In infant participants born to pregnant participants receiving a second dose of the study intervention, the percentage of participants reporting serious adverse events and newly diagnosed medical conditions.
Time frame: From birth through 6 months of age.
Proportion of participants achieving neutralizing antibody to RSV A and RSV B at birth
Time frame: At birth
Proportion of participants achieving neutralizing antibody to RSV A and RSV B at 3 months and 6 months
Time frame: At 3 months and 6 months
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Center for Research in Women's Health
Birmingham, Alabama, United States
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RECRUITINGUniversity of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, United States
RECRUITINGUniversity of Alabama at Birmingham Women & Infants Center
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