GSK-V72P13E1

Study Sponsor: GSK

Study Title

A Phase 3, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers Who Participated in Study V72P13

Medicine or Vaccine (generic name)

Meningococcal Serogroup B Vaccine

Sponsor Identification Number

V72P13E1

Trial Registry Identification Number(#'s)

NCT01139021 2008-006301-17

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/NCT01139021

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2008-006301-17

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 an extension study to V72P13. 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