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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 0 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Blinding only applies to Cohort 2 of the study.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
RSVpreF
  • Biological: RSVpreF
    Single Dose
Placebo Comparator
Placebo
  • Biological: Placebo
    Single Dose

Recruiting Locations

Center for Research in Women's Health
Birmingham, Alabama 35233

Children's of Alabama
Birmingham, Alabama 35233

University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama 35233

University of Alabama at Birmingham Women & Infants Center
Birmingham, Alabama 35233

USA Health Children's and Women's Hospital
Mobile, Alabama 36604

USA Health Strada Patient Care Center
Mobile, Alabama 36604

Ronald Reagan UCLA Medical Center
Los Angeles, California 90024

Ronald Reagan UCLA Medical Center (inpatient hospital)
Los Angeles, California 90095

Ronald Reagan UCLA Medical Center
Los Angeles, California 90095

UCLA (outpatient clinic)
Los Angeles, California 90095

UCLA Clinical and Translational Research Center (research clinic)
Los Angeles, California 90095

UCLA
Los Angeles, California 90095

Lucile Packard Children's Hospital-Labor and Delivery Unit
Palo Alto, California 94304

Stanford Obstetrics Clinic
Palo Alto, California 94304

Stanford University Medical Center
Palo Alto, California 94304

Stanford University
Palo Alto, California 94304

Anschutz Health Sciences Building (AHSB)
Aurora, Colorado 80045

Children's Hospital Colorado
Aurora, Colorado 80045

CU Research Pharmacy
Aurora, Colorado 80045

University of Colorado AO1 UCH
Aurora, Colorado 80045

University of Colorado Hospital Inpatient Pavilion
Aurora, Colorado 80045

University of Colorado Hospital Outpatient Pavilion
Aurora, Colorado 80045

University of Colorado Research II Building
Aurora, Colorado 80045

Citadelle Clinical Research
North Miami Beach, Florida 33162

Emerald Coast OBGYN Clinical Research
Panama City, Florida 32405

Emerald Coast Pediatrics
Panama City, Florida 32405

HCA Florida Gulf Coast Hospital
Panama City, Florida 32405

Emerald Coast Pediatrics
Panama City Beach, Florida 32407

Advanced Specialty Research
Boise, Idaho 83702

Saint Alphonsus Regional Medical Center
Boise, Idaho 83706

St. Luke's Boise Medical Center
Boise, Idaho 83712

Clinical Research Prime
Idaho Falls, Idaho 83404

Saint Alphonsus Medical Center
Nampa, Idaho 83687

St. Luke's Nampa Medical Center
Nampa, Idaho 83687

Accellacare - McFarland
Ames, Iowa 50010

Mary Greeley Medical Center
Ames, Iowa 50010

McFarland Clinic, PC
Ames, Iowa 50010

University of Kansas Medical Center
Kansas City, Kansas 66160

Velocity Clinical Research, Lafayette
Lafayette, Louisiana 70508

Velocity Clinical Research - New Orleans
New Orleans, Louisiana 70119

Boston Medical Center
Boston, Massachusetts 02118

Velocity Clinical Research, Gulfport
Gulfport, Mississippi 39503

Boeson Research GTF
Great Falls, Montana 59405

OBGYN Associates
Great Falls, Montana 59405

Boeson Research KAL
Kalispell, Montana 59901

Heart & Hands Midwifery
Kalispell, Montana 59901

Boeson Research MSO
Missoula, Montana 59804

Origin Health
Missoula, Montana 59804

Velocity Clinical Research, Grand Island
Grand Island, Nebraska 68803

Velocity Clinical Research, Norfolk
Norfolk, Nebraska 68701

Presbyterian Hospital
Albuquerque, New Mexico 87107

UNM Hospital
Albuquerque, New Mexico 87107

Velocity Clinical Research, Albuquerque
Albuquerque, New Mexico 87107

Lovelace Women's Hospital
Albuquerque, New Mexico 87109

Duke University - Main Hospital and Clinics
Durham, North Carolina 27705

Duke University - Main Hospital and Clinics
Durham, North Carolina 27710

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229

Prisma Health-Upstate
Greenville, South Carolina 29605

Prisma Health
Greenville, South Carolina 29605

Memorial Hermann Memorial City Hospital
Houston, Texas 77024

The University of Texas Health Science Center at Houston
Houston, Texas 77204

Helios Clinical Research - WEA
Weatherford, Texas 76086

Medical City Weatherford
Weatherford, Texas 76086

Weatherford OB/GYN Associates
Weatherford, Texas 76086

University of Utah
Salt Lake City, Utah 84112

University of Utah Clinical Neuroscience Center
Salt Lake City, Utah 84132

University of Utah Hospital
Salt Lake City, Utah 84132

University of Utah
Salt Lake City, Utah 84132

Sentara Leigh Hospital
Norfolk, Virginia 23502

The Group For Women - Kempsville Office
Norfolk, Virginia 23502

Tidewater Physicians for Women
Norfolk, Virginia 23502

WomensCare Center
Norfolk, Virginia 23502

Virginia Physicians For Women (VPFW)
North Chesterfield, Virginia 23235

Clinical Research Partners, LLC
Richmond, Virginia 23226

Infusion Solutions, LLC
Richmond, Virginia 23226

Seattle Children's Research Institute
Seattle, Washington 98101

Seattle Children's Hospital
Seattle, Washington 98105

University of Washington - Northwest
Seattle, Washington 98133

University of Washington Medical Center - Montlake
Seattle, Washington 98195

More Details

NCT ID
NCT06866405
Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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