GSK-217744/095 (DTPa-HBV-IPV-095)

Study Sponsor: GSK

Study Title

Study to assess immunogenicity and reactogenicity of GSK Bio’s DTPa-HBV-IPV/Hib vaccine when given as a booster dose to children previously primed at 2-4-6 months of age either with Aventis Pasteurs DTPa-HBV-IPV-Hib vaccine or GSK Bio’s DTPa-HBV-IPV/Hib vaccine in study DTPa-HBV-IPV-086

Medicine or Vaccine (generic name)

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

Sponsor Identification Number

217744/095 (DTPa-HBV-IPV-095)

Trial Registry Identification Number(#'s)

Medical Condition

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

Phase

Phase 4

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=217744/095

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

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

This is a booster to primary study 217744/086. An annotated case report form is not available for this study. A blank case report form will be provided. A reporting and analysis plan is not available for this study. A link to ClinicalTrials.gov and an NCTID number are not available for this study because the study is not in scope of regulatory requirements to register studies.

Date Added to this Site

June 2015