GSK-103488

Study Sponsor: GSK

Study Title

A randomized, controlled, phase II study to evaluate the safety and immunogenicity of different formulations of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly as a 3-dose primary immunization (2-3-4 month schedule) before 6 months of age

Medicine or Vaccine (generic name)

Combined Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, Inactivated Polio, Haemophilus influenzae Type b Vaccine

Sponsor Identification Number

103488

Trial Registry Identification Number(#'s)

NCT00169481

Medical Condition

acellular pertussis; Diphtheria; Haemophilus influenzae type b; Hepatitis B; Poliomyelitis; Tetanus

Phase

Phase 2

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=103488

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

http://clinicaltrials.gov/show/NCT00169481

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. A Reporing and tanalysis plan is not available for this study

Date Added to this Site

September 2016