GSK-107007

Study Sponsor: GSK

Study Title

To assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™, co-administered with DTPw-HBV/Hib & OPV or IPV vaccines as a 3-dose primary immunization course during the first 6 months of age

Medicine or Vaccine (generic name)

Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed)

Sponsor Identification Number

107007

Trial Registry Identification Number(#'s)

NCT00344318 2006-000557-21

Medical Condition

Infections, Streptococcal

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=107007

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

http://clinicaltrials.gov/show/NCT00344318

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2006-000557-21

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

October 2014