A Phase 3 Randomized Double- Or Observer-Blinded Placebo-Controlled Trial to Evaluate the Efficacy and Safety of a Respiratory Syncytial Versus (RSV) Prefusion F Subunit Vaccine in Infants Born To Women Vaccinated During Pregnancy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Respiratory Distress Of Newborn, Unspecified
  • Age: Between 18 years - 49 years
  • Gender: Female
  • Other Inclusion Criteria:
    1. Healthy women between 18 and 49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.
    2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    3. Receiving prenatal standard of care
    4. Had an ultrasound examination performed at =18 weeks of pregnancy with no significant fetal abnormalities observed, b
    5. Determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study.
    6. Documented negative HIV antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization (Visit 1).
    7. Intention to deliver at a hospital or birthing facility where study procedures can be obtained.
    8. Expected to be available for the duration of the study and can be contacted by telephone during study participation.
    9. Participant is willing to give informed consent for herself and for her infant to participate in the study.

You may not be eligible for this study if the following are true:

    1. Body mass index (BMI) of >40 kg/m2 at the time of the first obstetric visit during the current pregnancy.
    2. Bleeding diathesis or condition associated with prolonged bleeding
    3. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any related vaccine
    4. Current pregnancy resulting from in vitro fertilization.
    5. Current pregnancy complications or abnormalities
    6. Prior pregnancy complications or abnormalities at the time of consent, based on the investigator’s judgment, that will increase the risk associated with the participation in and completion of the study,
    7. Major illness of the maternal participant or conditions of the fetus that, in the investigator’s judgment, will substantially increase the risk
    8. Congenital or acquired immunodeficiency disorder, or rheumatologic disorder or other illness
    9. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation
    10. Current alcohol abuse or illicit drug use

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.