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.
Eligibility
Sex
ALL
Min age
0 Years
Max age
—
Healthy volunteers
Accepted
Pregnant Participants-Cohort 1 and Cohort 2 Key Inclusion Criteria
* Women aged 18 to 49 who are pregnant, between 24 and 36 weeks along, and expecting one baby without known risks for complications can participate.
* Had the RSVpreF or Abrysvo vaccine during a previous pregnancy.
* Had an ultrasound scan at 18 weeks or later during their current pregnancy, with no major fetal problems detected.
* Based on their medical history, physical check-up, and the doctor's judgment, they are found suitable to join the study.
* Agrees to let their baby take part in the study and gives their permission.
* Able to sign a consent form, agreeing to follow the rules and conditions of the study.
Key Exclusion Criteria
* Received any approved or experimental RSV vaccine since their previous pregnancy.
* Has a pre-pregnancy body mass index (BMI) over 40 kg/m2.
* History of a severe bad reaction to a vaccine or a serious allergic reaction (like anaphylaxis) to any ingredient in the study vaccine or a similar vaccine.
* Current pregnancy problems or issues at the time of giving consent.
* Previous pregnancy issues or problems at the time of giving consent.
* Women who are breastfeeding at the time of enrollment
Infant Participants
* Proof that the parent(s) or legal guardian(s) has signed and dated a consent form.
* Parent(s) or legal guardian(s) must agree to attend scheduled visits and follow the study plan, including laboratory tests and other procedures.
Nonpregnant Participants-Cohort 3 Key Inclusion Criteria
* Have already received one dose of the RSVpreF vaccine during their previous pregnancy as part of the Pfizer clinical trial, and the results from that time can be used for this study.
* Able to sign a consent form, agreeing to follow the rules and requirements of the study.
Key Exclusion Criteria
* Received any approved or experimental RSV vaccine after participating in the Pfizer clinical trial.
* Taking part in other studies with new drugs within 28 days before giving consent or during the study period.
Primary outcome measure(s)
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
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
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.
Proportion of participants achieving neutralizing antibody to RSV A and RSV B at birth — At birth
Trial sites (96)
Facility
City
Region
Status
Center for Research in Women's Health
Birmingham
Alabama
Recruiting
Children's of Alabama
Birmingham
Alabama
Recruiting
University of Alabama at Birmingham - School of Medicine
Birmingham
Alabama
Recruiting
University of Alabama at Birmingham Women & Infants Center
Birmingham
Alabama
Recruiting
USA Health Children's and Women's Hospital
Mobile
Alabama
Recruiting
USA Health Strada Patient Care Center
Mobile
Alabama
Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles
California
Recruiting
Ronald Reagan UCLA Medical Center (inpatient hospital)
Los Angeles
California
Recruiting
Ronald Reagan UCLA Medical Center
Los Angeles
California
Recruiting
UCLA (outpatient clinic)
Los Angeles
California
Recruiting
UCLA Clinical and Translational Research Center (research clinic)
Los Angeles
California
Recruiting
UCLA
Los Angeles
California
Recruiting
Lucile Packard Children's Hospital-Labor and Delivery Unit
Palo Alto
California
Recruiting
Stanford Obstetrics Clinic
Palo Alto
California
Recruiting
Stanford University Medical Center
Palo Alto
California
Recruiting
Stanford University
Palo Alto
California
Recruiting
Anschutz Health Sciences Building (AHSB)
Aurora
Colorado
Recruiting
Children's Hospital Colorado
Aurora
Colorado
Recruiting
CU Research Pharmacy
Aurora
Colorado
Recruiting
University of Colorado AO1 UCH
Aurora
Colorado
Recruiting
University of Colorado Hospital Inpatient Pavilion
Aurora
Colorado
Recruiting
University of Colorado Hospital Outpatient Pavilion
Aurora
Colorado
Recruiting
University of Colorado Research II Building
Aurora
Colorado
Recruiting
Citadelle Clinical Research
North Miami Beach
Florida
Recruiting
Emerald Coast OBGYN Clinical Research
Panama City
Florida
Recruiting
Emerald Coast Pediatrics
Panama City
Florida
Recruiting
HCA Florida Gulf Coast Hospital
Panama City
Florida
Recruiting
Advanced Specialty Research
Boise
Idaho
Recruiting
Saint Alphonsus Regional Medical Center
Boise
Idaho
Recruiting
St. Luke's Boise Medical Center
Boise
Idaho
Recruiting
Clinical Research Prime
Idaho Falls
Idaho
Recruiting
Saint Alphonsus Medical Center
Nampa
Idaho
Recruiting
St. Luke's Nampa Medical Center
Nampa
Idaho
Recruiting
Accellacare - McFarland
Ames
Iowa
Recruiting
Mary Greeley Medical Center
Ames
Iowa
Recruiting
McFarland Clinic, PC
Ames
Iowa
Recruiting
University of Kansas Medical Center
Kansas City
Kansas
Recruiting
Velocity Clinical Research - New Orleans
New Orleans
Louisiana
Recruiting
Boston Medical Center
Boston
Massachusetts
Recruiting
Velocity Clinical Research, Gulfport
Gulfport
Mississippi
Recruiting
+ 56 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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