GSK-208068

Study Sponsor: GSK

Study Title

A Phase I/II randomized observer-blind placebo controlled study to evaluate the safety, reactogenicity and immunogenicity of different dose levels of GSK Biologicals’ investigational unadjuvanted RSV Maternal vaccine (GSK3888550A) compared to placebo when administered to healthy non-pregnant women aged 18-45 years

Medicine or Vaccine (generic name)

GSK3888550A

Sponsor Identification Number

208068

Trial Registry Identification Number(#'s)

NCT03674177

Medical Condition

Respiratory Syncytial Virus Infections

Phase

Phase 1

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=208068

Link to study details on ClinicalTrials.gov (if available)

http://clinicaltrials.gov/show/NCT03674177

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=/2018-001340-62

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

This study is available in CDISC format.

Date Added to this Site

July 2021