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

NCT03614676 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4493

Last updated 2023-08-14

Study results available
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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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

PROCEDURE

Blood sample collection

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

PROCEDURE

Cord blood sample collection

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

OTHER

Maternal Diary Card

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

PROCEDURE

Nasal Swab collection

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

OTHER

Infant Diary Card

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-30
Primary Completion
2021-07-27
Completion
2021-07-27

Countries

  • Argentina
  • Bangladesh
  • Brazil
  • Colombia
  • Malaysia
  • Mexico
  • Panama
  • Philippines
  • South Africa
  • Thailand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03614676 on ClinicalTrials.gov