a study of outcomes and events of interest in pregnant women, neonates and infants and of rsv surveillance

Conditions: Respiratory Syncytial Virus Infections

Summary: the purpose of this study is to assess pregnancy outcomes, and maternal, as well as neonatal events of interest in healthy pregnant women and their new-borns. the study will also determine incidence of lower respiratory tract illness (lrti) caused by respiratory syncytial virus (rsv) in the new-borns during their first year of life.


Eligibility criteria:
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

Keywords: third trimester respiratory syncytial virus (rsv) illness pregnancy maternal immunization pregnant women neonates respiratory tract illness