Phase
Condition
Respiratory Syncytial Virus (Rsv)
Respiratory Syncytial Virus (Rsv) Infection
Treatment
Placebo
RSVpreF
Clinical Study ID
All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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.
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
Study Description
Connect with a study center
Lucile Packard Children's Hospital
Palo Alto, California 94304
United StatesSite Not Available
Lucile Packard Children's Hospital-Labor and Delivery Unit
Palo Alto, California 94304
United StatesSite Not Available
Stanford University
Palo Alto, California 94304
United StatesSite Not Available
Stanford University Medical Center
Palo Alto, California 94304
United StatesSite Not Available
Emerald Coast OBGYN Clinical Research
Panama City, Florida 32405
United StatesSite Not Available
Emerald Coast Pediatrics
Panama City, Florida 32405
United StatesSite Not Available
HCA Florida Gulf Coast Hospital
Panama City, Florida 32405
United StatesSite Not Available
Emerald Coast Pediatrics
Panama City Beach, Florida 32407
United StatesSite Not Available
Advanced Specialty Research
Boise, Idaho 83702
United StatesActive - Recruiting
Saint Alphonsus Regional Medical Center
Boise, Idaho 83706
United StatesActive - Recruiting
St. Luke's Boise Medical Center
Boise, Idaho 83712
United StatesActive - Recruiting
Clinical Research Prime
Idaho Falls, Idaho 83404
United StatesActive - Recruiting
Saint Alphonsus Medical Center
Nampa, Idaho 83687
United StatesActive - Recruiting
St. Luke's Nampa Medical Center
Nampa, Idaho 83687
United StatesActive - Recruiting
Velocity Clinical Research, Lafayette
Lafayette, Louisiana 70508
United StatesSite Not Available
Velocity Clinical Research - New Orleans
New Orleans, Louisiana 70119
United StatesActive - Recruiting
Boston Medical Center
Boston, Massachusetts 02118
United StatesSite Not Available
Velocity Clinical Research, Gulfport
Gulfport, Mississippi 39503
United StatesSite Not Available
Boeson Research GTF
Great Falls, Montana 59405
United StatesActive - Recruiting
OBGYN Associates
Great Falls, Montana 59405
United StatesActive - Recruiting
Boeson Research KAL
Kalispell, Montana 59901
United StatesActive - Recruiting
Heart & Hands Midwifery
Kalispell, Montana 59901
United StatesActive - Recruiting
Boeson Research Laboratory
Missoula, Montana 59804
United StatesSite Not Available
Boeson Research MSO
Missoula, Montana 59804
United StatesActive - Recruiting
Origin Health
Missoula, Montana 59804
United StatesActive - Recruiting
Velocity Clinical Research, Grand Island
Grand Island, Nebraska 68803
United StatesActive - Recruiting
Velocity Clinical Research, Norfolk
Norfolk, Nebraska 68701
United StatesActive - Recruiting
Lovelace Women's Hospital
Albuquerque, New Mexico 87109
United StatesActive - Recruiting
Presbyterian Hospital
Albuquerque, New Mexico 87107
United StatesActive - Recruiting
UNM Hospital
Albuquerque, New Mexico 87107
United StatesActive - Recruiting
Velocity Clinical Research, Albuquerque
Albuquerque, New Mexico 87107
United StatesActive - Recruiting
Memorial Hermann Memorial City Hospital
Houston, Texas 77024
United StatesActive - Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas 77204
United StatesActive - Recruiting
Sentara Leigh Hospital
Norfolk, Virginia 23502
United StatesActive - Recruiting
The Group For Women - Kempsville Office
Norfolk, Virginia 23502
United StatesActive - Recruiting
Tidewater Physicians for Women
Norfolk, Virginia 23502
United StatesActive - Recruiting
WomensCare Center
Norfolk, Virginia 23502
United StatesActive - Recruiting
Virginia Physicians For Women (VPFW)
North Chesterfield, Virginia 23235
United StatesActive - Recruiting
Clinical Research Partners, LLC
Richmond, Virginia 23226
United StatesActive - Recruiting
Infusion Solutions, LLC
Richmond, Virginia 23226
United StatesActive - Recruiting
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