Bexsero® pregnancy registry: an observational study of the safety of Bexsero® exposure in pregnant women and their offspring

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36639
• EU PAS number:
  EUPAS12183
• Study ID:
  36639
• Official title and acronym:
  Bexsero® pregnancy registry: an observational study of the safety of Bexsero® exposure in pregnant women and their offspring
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  4CMenB was approved by the European Medicines Agency (EMA) in January 2013 and is indicated for active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B. 4CMenB can be considered for use during pregnancy where there is a clear risk of exposure to meningococcal infection and sometimes, inadvertent exposure during pregnancy may also occur - before the woman knows she is pregnant, for example. The objective of this study is to evaluate the safety of 4CMenB during pregnancy and to help us learn more about the health of women who have been vaccinated with 4CMenB within 30 days prior to their last menstrual period (LMP) or at any time during pregnancy, and the health of their infants. The study will be conducted (with EMA approval) in the US. Pregnant women within the US who received at least 1 dose 4CMenB vaccine within 30 days prior to their last menstrual period or at any time during pregnancy are eligible to participate. A woman may self-enroll in the registry by calling the pregnancy registry telephone number directly or their healthcare provider (HCP) can, with their consent, enroll them on their behalf. Alternatively HCPs may report anonymous data on pregnancy exposures and outcomes occurring within their network/health maintenance organization (HMO). The health of the woman and her infant will be followed up until the end of the pregnancy
• Study status:
  Finalised

Research institutions and networks

Institutions

Pharmaceutical Product Development (PPD)

Study timelines

Date when funding contract was signed

Actual: 24/11/2015

Study start date

Actual: 31/01/2016

Date of final study report

Actual: 02/03/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Vaccines, now a GSK company

Study protocol

Initial protocol

V72_82OB-08_Other_(Specify)-Redacted_Protocol_for_ENCePP-v1-2015-11-20-77194739

Updated protocol

gsk-205533-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)