Last updated: 07/21/2023 08:00:36
A study of outcomes and events of interest in pregnant women, neonates and infants and of RSV surveillancePEPNI
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A prospective epidemiological study of pregnancy outcomes and of events of interest in pregnant women, neonates and infants (PEPNI)
Trial description: 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.
Primary purpose:
Screening
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of maternal subjects with pregnancy outcomes
Timeframe: From Day 1 up to Day 42 post delivery
Number of maternal subjects with pregnancy related events of interest
Timeframe: From Day 1 up to Day 42 post-delivery
Number of infant subjects with neonatal events of interest
Timeframe: From birth up to Day 28 post-birth
Secondary outcomes:
Number of maternal subjects with pregnancy related events of interest for each Global Alignment of Immunization Safety Assessment (GAIA) level of diagnostic certainty
Timeframe: From Day 1 up to Day 42 post-delivery
Number of infant subjects with neonatal events of interest for each GAIA level of diagnostic certainty
Timeframe: From birth through Day 28 of life
Respiratory syncytial virus type A (RSV-A) neutralizing antibody titers in maternal blood
Timeframe: At delivery
RSV-A neutralizing antibodies titers in cord blood
Timeframe: At delivery
Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI or Very severe LRTI for infant subjects as Defined by the LRTI Case Definition
Timeframe: From birth up to 1 year of age
Incidence Rates of infant subjects with RSV hospitalizations
Timeframe: From birth up to 1 year of age
Interventions:
Enrollment:
4493
Primary completion date:
2021-27-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Respiratory Syncytial Virus Infections
Product
GSK3003891A
Collaborators
Not applicable
Study date(s)
May 2019 to July 2021
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 40 Years
Accepts healthy volunteers
Yes
- 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.
- Individuals determined to have one of the following conditions associated with increased risk for a serious obstetrical complication
- Gestational hypertension;
Inclusion and exclusion criteria
Inclusion criteria:
- 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).
- 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.
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
Both mother and father should consent if local regulations/guidelines require it.
Exclusion criteria:
- Gestational hypertension;
- Gestational diabetes uncontrolled by diet and exercise;
- Pre-eclampsia or eclampsia;
- Multiple pregnancy;
- Intrauterine growth restriction;
- Placenta previa;
- Polyhydramnios;
- Individuals determined to have (during the current pregnancy) one of the following infections or conditions associated with risk of adverse outcome:
- Known or suspected: o Syphilis infection, o Parvovirus B19, o Rubella infection, o primary herpes simplex infection, o primary cytomegalovirus infection, o varicella infection, o Zika infection, o Active tuberculosis infection,
- 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
Individuals determined to have one of the following conditions associated with increased risk for a serious obstetrical complication
Oligohydramnios;
Incompetent cervix or cerclage
Trial location(s)
Showing 1 - 6 of 38 Results
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2021-27-07
Actual study completion date
2021-27-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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