GSK-107046

Study Sponsor: GSK

Study Title

To assess the safety, reactogenicity & immunogenicity of a 4th dose of GSK Biologicals’ pneumococcal vaccine or Prevenar™ in children (12-18 months) previously vaccinated in the primary study 105553 with either pneumococcal vaccine or Prevenar™

Medicine or Vaccine (generic name)

Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed)

Sponsor Identification Number

107046

Trial Registry Identification Number(#'s)

NCT00370396 2006-001628-38

Medical Condition

Infections, Streptococcal

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=107046

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

http://clinicaltrials.gov/show/NCT00370396

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2006-001628-38

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 is a booster study of 105553. Follow-on studies 112640, 111345, 111346, and 111347 were 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

October 2014