A study of outcomes and events of interest in pregnant women, neonates and infants and of RSV surveillancePEPNI

Healthy pregnant women 18-45years of age who are ≥ 24 0/7 weeks GA at screening and ≤ 27 6/7 weeks GA at Visit 1, as established by ultrasound examination and/or last menstrual period (LMP) date

• Women with pre-pregnancy body mass index (BMI) ≥18.5 and ≤ 39.9 kg/m2.
• Women whose pregnancy is considered low risk, based on medical history, obstetric history, and clinical findings during the current pregnancy
• Women who had no significant findings (such as abnormal fetal morphology, amniotic fluid levels, placenta, or umbilical cord) observed during a Level 2 ultrasound (fetal morphology assessment).
• Human Immunodeficiency Virus (HIV) uninfected women who have been tested within the past year and have documented HIV negative test results.
• Individuals who give written or witnessed/thumb printed informed consent after the study has been explained according to local regulatory requirements.

Both mother and father should consent if local regulations/guidelines require it.

• Individuals who consent to have cord blood collected at delivery for the purpose of the study;
• Individuals who plan to reside in the study area for at least one year after delivery.
• Individuals who are in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
• Individuals who, in the opinion of the investigator can and will comprehend and comply with all study procedures
• Infants who were in utero at the time maternal (and paternal, if required) informed consent was given, and who are live-born.
• If local law requires it: Written or witnessed/thumb printed informed consent for study participation of the infant obtained from parent(s)/Legally Accepted Representative [LAR(s)] within 21 days of birth.

Individuals determined to have one of the following conditions associated with increased risk for a serious obstetrical complication

Oligohydramnios;

• Individuals determined to have (during the current pregnancy) one of the following infections or conditions associated with risk of adverse outcome:

Incompetent cervix or cerclage

• Individuals who have any underlying condition or infection that would predispose them to increased risk for a serious obstetrical complication that is not mentioned above
• Individuals who have behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study;
• Individuals who have known or suspected impairment of the immune system, an active autoimmune disorder that is not well-controlled, or who are receiving systemic immunosuppressive therapy;
• Individuals participating in any concurrent clinical trial during the current pregnancy;
• Individuals pregnant with a fetus with a confirmed or suspected major congenital anomaly at the time of enrolment.
• Child in care