GSK-257049/034

Study Sponsor: GSK

Study Title

A bridging study to evaluate the safety and immunogenicity of GSK Biologicals’ candidate vaccines RTS,S/AS02D (0.5 mL dose) and RTS,S/AS02A (0.25 mL dose) administered according to a 0, 1, 2 month vaccination schedule in children aged 3 to 5 years living in a malaria-endemic region of Mozambique.

Medicine or Vaccine (generic name)

RTS,S Vaccine

Sponsor Identification Number

257049/034

Trial Registry Identification Number(#'s)

NCT00197067

Medical Condition

Malaria

Phase

Phase 1

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=257049/034

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

http://clinicaltrials.gov/show/NCT00197067

Link to study details on EudraCT (if available)

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

An annotated case report form is not available for this study. A blank case report form will be provided.

Date Added to this Site

February 2019