GSK-109621

Study Sponsor: GSK

Study Title

Safety, reactogenicity and immunogenicity following booster dose of GSK Biologicals´ pneumococcal conjugate vaccine when co-administered with a booster dose of Infanrix-IPV/Hib in preterm born children at 16-18 months of age

Medicine or Vaccine (generic name)

Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed)

Sponsor Identification Number

109621

Trial Registry Identification Number(#'s)

NCT00609492 2007-000596-42

Medical Condition

Infections, Streptococcal

Phase

Phase 3

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=109621

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

http://clinicaltrials.gov/show/NCT00609492

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2007-000596-42

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

Date Added to this Site

May 2013