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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Respiratory Syncytial Virus Infections

Treatments: Other: Infant Diary Card; Procedure: Blood sample collection; Procedure: Cord blood sample collection; Procedure: Nasal Swab collection; Other: Maternal Diary Card

Study type: Interventional

Funder types: Industry

Identifiers

NCT03614676

207636

Details and patient eligibility

About

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.

Enrollment: 4,493 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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4,493 participants in 2 patient groups

Pregnant Women/Mothers Group

Other group

Description:

Subjects, 18 to 45 years of age enrolled in the study in view of determining pregnancy outcomes and related events of interest, as well as the occurrence of lower respiratory tract illness (LRTI) associated with respiratory syncytial virus (RSV).

Treatment:

Procedure: Cord blood sample collection

Other: Maternal Diary Card

Procedure: Blood sample collection

Neonates/Infants Group

Other group

Description:

Infants born to mothers aged 18-45 years old, enrolled for the collection of infant events of interest, nasal swabs and the incidence of RSV LRTI and RSV hospitalization.

Treatment:

Other: Infant Diary Card

Procedure: Nasal Swab collection