GSK-V72P13

Study Sponsor: GSK

Study Title

A Phase 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Medicine or Vaccine (generic name)

Meningococcal Serogroup B Vaccine

Sponsor Identification Number

V72P13

Trial Registry Identification Number(#'s)

NCT00657709 2007-007781-38

Medical Condition

Infections, Meningococcal

Phase

Phase 3

Link to GSK Study Register

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

http://clinicaltrials.gov/show/NCT00657709

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2007-007781-38

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

Extension study V12P13E1 was conducted. An analysis-ready dataset is not available for this study. There is no GSK Study Register entry for this study.

Date Added to this Site

October 2015