A Phase 3 Study to Investigate the Safety, Tolerability, and Immunogenicity of Revaccinating Pregnant Participants During Subsequent Pregnancies and Persistence of Immunity of a Single Dose of a Bivalent Respiratory Syncytial Virus (RSV) Vaccine.
A Phase 3 Study to Investigate the Safety, Tolerability, and Immunogenicity of Revaccinating Pregnant Participants During Subsequent Pregnancies and Persistence of Immunity of a Single Dose of a Bivalent Respiratory Syncytial Virus (RSV) Vaccine.
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:
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.
Pregnant Participants-Cohort 1 and Cohort 2 Key Inclusion Criteria
Key Exclusion Criteria
Infant Participants
Nonpregnant Participants-Cohort 3 Key Inclusion Criteria
Key Exclusion Criteria
ClinicalTrials.gov_Inquiries@pfizer.com1-800-718-1021
Birmingham, Alabama 35233, United States
Birmingham, Alabama 35233, United States
Los Angeles, California 90095, United States
Los Angeles, California 90095, United States
Palo Alto, California 94304, United States
Houston, Texas 77204, United States
Salt Lake City, Utah 84108, United States
Salt Lake City, Utah 84112, United States
Seattle, Washington 98195, United States
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ABP, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
Johannesburg, Gauteng 1864, South Africa
Cape Town, Western Cape 7700, South Africa