GSK-105553

Study Sponsor: GSK

Study Title

Assess lot-to-lot consistency of 3 lots (double blind design) of GlaxoSmithKline Biologicals' 10-valent pneumococcal vaccine and evaluate non-inferiority to Prevenar™ (single blind design) when administered as 3-dose primary immunization course before 6 months of age

Medicine or Vaccine (generic name)

Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed)

Sponsor Identification Number

105553

Trial Registry Identification Number(#'s)

NCT00307554 2005-003300-11

Medical Condition

Infections, Streptococcal

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=105553

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

http://clinicaltrials.gov/show/NCT00307554

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2005-003300-11

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

Follow-on studies 107046, 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