A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance

Inclusion criteria

• 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.

• The informed consent given at screening should either include consent for both the mother's participation and participation of the infant after the infant's birth (if consistent with local regulations/guidelines), or consent for the mother's participation and expressed willingness to consider permitting the infant to take part after the infant has been born (if local regulations/guidelines require parent(s) to provide an additional informed consent after the infant's birth).
• 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.

Exclusion criteria

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

• Gestational hypertension;
• Gestational diabetes uncontrolled by diet and exercise;
• Pre-eclampsia or eclampsia;
• Multiple pregnancy;
• Intrauterine growth restriction;
• Placenta previa;
• Polyhydramnios;
• Oligohydramnios;
• Individuals determined to have (during the current pregnancy) one of the following infections or conditions associated with risk of adverse outcome:

• Known or suspected:

• Syphilis infection,
• Parvovirus B19,
• Rubella infection,
• primary herpes simplex infection,
• primary cytomegalovirus infection,
• varicella infection,
• Zika infection,
• Active tuberculosis infection,
• 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