Study of Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline's (GSK)Respiratory Syncytial Virus (RSV)Maternal Unadjuvanted Vaccine in Healthy Pregnant Women (Aged 18 to 40 Years) and Their Infants
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 300
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. The laboratory in charge of the sample testing will be blinded to the intervention assignment, codes will be used to link the subject and study (without any link to the intervention attributed to the subject) to each sample. Investigators will remain blinded to each subject's assigned study intervention until the second analysis. After the second analysis, the study will not be considered observer blind as the investigator brochure will be updated to include safety information presented by treatment group. This could lead to inadvertent unblinding of investigators and site staff to some subjects' treatment assignments. The subjects themselves will remain blinded throughout their participation in the study.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 40 years
- Gender
- Only males
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04126213
- Collaborators
- Not Provided
- Investigators
- Study Director: GSK Clinical Trials GlaxoSmithKline
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