GSK-105539

Study Sponsor: GSK

Study Title

An open, randomized, phase IIIa study to evaluate the safety and immunogenicity of GSK Biologicals' 10-valent pneumococcal conjugate vaccine, when administered intramuscularly according to a 2-4-11 months vaccination schedule

Medicine or Vaccine (generic name)

Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed)

Sponsor Identification Number

105539

Trial Registry Identification Number(#'s)

NCT00307034 2005-003437-41

Medical Condition

Infections, Streptococcal

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=105539

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

http://clinicaltrials.gov/show/NCT00307034

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2005-003437-41

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

A follow-on study 111736 was conducted. An annotated case report form is not available for this study. A blank case report form will be provided.

Date Added to this Site

September 2013