GSK-213503/048

Study Sponsor: GSK

Study Title

Safety, immunogenicity&consistency of 3 manufacturing lots of DTaP-IPV vaccine vs separate injections of GSK Biologicals' DTaP + Aventis Pasteur's IPV admd as booster doses to healthy children 4-6 yrs, each co-admd with Merck's MMR vaccine

Medicine or Vaccine (generic name)

Diphtheria, Tetanus, Acellular Pertussis Vaccine Adsorbed

Sponsor Identification Number

213503/048

Trial Registry Identification Number(#'s)

NCT00148941

Medical Condition

Acellular pertussis; Diphtheria; Tetanus

Phase

Phase 3

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=213503/048

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

http://clinicaltrials.gov/show/NCT00148941

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.

Date Added to this Site

September 2013