Trials / Completed
CompletedNCT03614676
A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance
A Prospective Epidemiological Study of Pregnancy Outcomes and of Events of Interest in Pregnant Women, Neonates and Infants (PEPNI)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4,493 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-05-30
- Primary completion
- 2021-07-27
- Completion
- 2021-07-27
- First posted
- 2018-08-03
- Last updated
- 2023-08-14
- Results posted
- 2023-08-14
Locations
40 sites across 10 countries: Argentina, Bangladesh, Brazil, Colombia, Malaysia, Mexico, Panama, Philippines, South Africa, Thailand
Source: ClinicalTrials.gov record NCT03614676. Inclusion in this directory is not an endorsement.