205514 (V72_38OB) - Post-licensure observational effectiveness study of meningococcal B vaccine 4CMenB (Bexsero®) vaccination

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33821
• EU PAS number:
  EUPAS10416
• Study ID:
  33821
• Official title and acronym:
  205514 (V72_38OB) - Post-licensure observational effectiveness study of meningococcal B vaccine 4CMenB (Bexsero®) vaccination
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The purpose of this study is to investigate the effectiveness of 4CMenB vaccination during routine clinical care in the UK national immunisation programme (NIP).
• Study status:
  Finalised

Research institutions and networks

Institutions

Public Health England (PHE)

Study timelines

Date when funding contract was signed

Actual: 02/11/2011

Study start date

Actual: 01/09/2015

Data analysis start date

Actual: 01/10/2015

Date of final study report

Actual: 24/05/2019

Sources of funding

Other

More details on funding

This surveillance was conducted by Public Health England. Post-marketing surveillance reports were provided to GSK to comply with their Risk Management Strategy.GSK provided funding for purchasing the reports and provided the MATS kits.See section 19

Study protocol

Initial protocol

V72_38OB-04 Trial Registration Form-ENCePP Registration Redacted Protocol-2015-07-03

Updated protocol

gsk-205514-protocol-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)