GSK-100917

Study Sponsor: GSK

Study Title

An open, multicentric, post-marketing surveillance study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib vaccine administered at 3, 4, 5 and 18 months of age, in healthy infants.

Medicine or Vaccine (generic name)

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

Sponsor Identification Number

100917

Trial Registry Identification Number(#'s)

NCT00325156 2015-001512-35

Medical Condition

Acellular pertussis; Diphtheria; Haemophilus influenzae type b; Poliomyelitis; Tetanus

Phase

Phase 4

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=100917

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

http://clinicaltrials.gov/show/NCT00325156

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2015-001512-35

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