GSK-107017

Study Sponsor: GSK

Study Title

Multicentre study to assess the effect of prophylactic antipyretic treatment on the rate of febrile reactions following concomitant administration of GSK Biologicals’ 10-valent pneumococcal conjugate, Infanrix hexa and Rotarix vaccines

Medicine or Vaccine (generic name)

Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed)

Sponsor Identification Number

107017

Trial Registry Identification Number(#'s)

NCT00370318 2006-000559-16

Medical Condition

Infections, Streptococcal

Phase

Phase 3

Link to GSK Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=107017

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

http://clinicaltrials.gov/show/NCT00370318

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2006-000559-16

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

A follow-on study 107137 was conducted. 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