A Study of Outcomes and Events of Interest in Pregnant Women, Neonates and Infants and of RSV Surveillance
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 4000
Summary
- Conditions
- Respiratory Syncytial Virus Infections
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: Single Group Assignment is selected because this is a low-interventional, epidemiological study. As such, the study does not have multiple groups/treatment arms that will be compared against one another statistically in the way two study arms would be compared against each other in a clinical trial. Instead, the study will longitudinally follow pregnant women through a 42-day post-delivery period and will also follow the infants born to these women. It should be noted that these are the two populations listed in the protocol, but these are not two groups that will compared against one another. Statistical analyses will be conducted within each group and some analyses will be done across the two groups. However, these two groups should not be considered equivalent to two study arms. This explains why a single group assignment is appropriate while two study groups (mothers and infants) will be examined.Masking: None (Open Label)Primary Purpose: Screening
Participation Requirements
- Age
- Between 18 years and 40 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT03614676
- Collaborators
- Not Provided
- Investigators
- Study Director: GSK Clinical Trials GlaxoSmithKline
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