Pregnancy and birth outcome assessment in a population-based cohort after exposure to Trumenba

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44934
• EU PAS number:
  EUPAS21984
• Study ID:
  44934
• Official title and acronym:
  Pregnancy and birth outcome assessment in a population-based cohort after exposure to Trumenba
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This population based cohort study is designed to assess pregnancy and birth outcomes following accidental or planned exposure to vaccination with Trumenba up to 28 days prior to or during pregnancy using electronic healthcare data in the United States (US).
• Study status:
  Finalised

Research institutions and networks

Institutions

Harvard Pilgrim Health Care Institute

Study timelines

Date when funding contract was signed

Planned: 07/09/2017

Actual: 05/09/2017

Study start date

Planned: 30/06/2021

Actual: 30/06/2021

Data analysis start date

Planned: 14/07/2021

Date of final study report

Planned: 31/12/2021

Actual: 16/12/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

B1971052 Protocol Amendment 1, 20 March 2017 Clean

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)