A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 500
Summary
- Conditions
- Respiratory Syncytial Virus Infections
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Data will be collected in an observer-blind manner. In an observer-blind study, the subject and the site and sponsor personnel involved in the clinical evaluation of the subjects are blinded while other study personnel may be aware of the treatment assignment. By observer-blind, it is meant that during the course of the study, the vaccine(s) recipient and those responsible for the evaluation of any study endpoint (e.g. safety, reactogenicity) will all be unaware of which vaccines were administered.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Only males
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04138056
- Collaborators
- Not Provided
- Investigators
- Study Director: GSK Clinical Trials GlaxoSmithKline
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