GSK-347414/035

Study Sponsor: GSK

Study Title

A phase-III, open, controlled, follow-up clinical trial, with Prevenar as control, to assess the safety of GSK Biologicals’ investigational vaccination regimen administered with DTPa-HBV-IPV/Hib to healthy children, previously vaccinated in infancy with the investigational vaccination regimen in a primary study in the Netherlands

Medicine or Vaccine (generic name)

Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed)

Sponsor Identification Number

347414/035

Trial Registry Identification Number(#'s)

Medical Condition

Infections, Streptococcal

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=347414/035

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 follow-up study to 347414/020. An annotated case report form is not available. A blank case report form will be provided. A reporting and analysis plan is not available for this study. A clinical study report and a protocol are not available for this study because only draft versions were located; no final version found in archives. 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

October 2015