A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose
- Registration Number
- NCT06866405
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 550
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RSVpreF RSVpreF - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Percentage of pregnant participants reporting local reactions From Day 1 Through at least Day 7 after Vaccination Pain at the injection site, redness, and swelling
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. From birth through 6 months of age. Percentage of pregnant participants reporting systemic events From Day 1 Through at least Day 7 after Vaccination Fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain
Percentage of pregnant participants reporting adverse events From Day 1 through 4 weeks after vaccination Percentage of pregnant participants reporting serious adverse events 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. From birth through 1 month of age Proportion of participants achieving neutralizing antibody to RSV A and RSV B at birth At birth
- Secondary Outcome Measures
Name Time Method Proportion of participants achieving neutralizing antibody to RSV A and RSV B at 3 months and 6 months At 3 months and 6 months
Related Research Topics
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Trial Locations
- Locations (23)
Advanced Specialty Research
🇺🇸Boise, Idaho, United States
Saint Alphonsus Regional Medical Center
🇺🇸Boise, Idaho, United States
Velocity Clinical Research - New Orleans
🇺🇸New Orleans, Louisiana, United States
Velocity Clinical Research, Gulfport
🇺🇸Gulfport, Mississippi, United States
OBGYN Associates
🇺🇸Great Falls, Montana, United States
UNM Hospital
🇺🇸Albuquerque, New Mexico, United States
Lovelace Women's Hospital
🇺🇸Albuquerque, New Mexico, United States
St. Luke's Boise Medical Center
🇺🇸Boise, Idaho, United States
Velocity Clinical Research, Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Virginia Physicians For Women (VPFW)
🇺🇸North Chesterfield, Virginia, United States
Saint Alphonsus Medical Center
🇺🇸Nampa, Idaho, United States
Boeson Research Laboratory
🇺🇸Missoula, Montana, United States
Presbyterian Hospital
🇺🇸Albuquerque, New Mexico, United States
Clinical Research Partners, LLC
🇺🇸Richmond, Virginia, United States
St. Luke's Nampa Medical Center
🇺🇸Nampa, Idaho, United States
Boeson Research KAL
🇺🇸Kalispell, Montana, United States
Velocity Clinical Research, Grand Island
🇺🇸Grand Island, Nebraska, United States
Velocity Clinical Research, Norfolk
🇺🇸Norfolk, Nebraska, United States
Infusion Solutions, LLC
🇺🇸Richmond, Virginia, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Boeson Research GTF
🇺🇸Great Falls, Montana, United States
Heart & Hands Midwifery
🇺🇸Kalispell, Montana, United States
Boeson Research MSO
🇺🇸Missoula, Montana, United States