CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4,493 enrolled
Drug / intervention
Blood sample collection +4 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03614676
NCT03614676N/ACompleted
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A Prospective Epidemiological Study of Pregnancy Outcomes and of Events of Interest in Pregnant Women, Neonates and Infants (PEPNI)

GlaxoSmithKline·interventional·Posted Aug 3, 2018·Updated Aug 14, 2023

In Brief

A clinical study evaluating Blood sample collection, Cord blood sample collection, and 3 other interventions for Respiratory Syncytial Virus Infections. Completed, enrolled 4,493 participants across 40 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesArgentina, Bangladesh, Brazil, Colombia, Malaysia, Mexico, Panama, Philippines, South Africa, Thailand
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 3, 2018
Enrollment StartMay 30, 2019
Primary CompletionJul 27, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.9 years ago

Interventions

Blood sample collectionprocedure

Venous blood samples will be collected from the maternal subjects at Day 1 and Day 56 of the study and at delivery.

Cord blood sample collectionprocedure

Collection of cord blood samples from maternal subjects will occur, at delivery

Maternal Diary Cardother

Completion of Diary Card about health by pregnant woman/ mother, from enrolment through week 6 post delivery.

Nasal Swab collectionprocedure

Collection of nasal swabs from infants with potential LRTIs, from birth to 12 months of age.

Infant Diary Cardother

Completion of Diary Card about health of infant from birth to 12 months of age.