207221 - An observational, retrospective cohort database study to assess the safety of Boostrix (U.S. formulation), a reduced tetanus, diphtheria, acellular pertussis vaccine (Tdap), following routine immunization of pregnant women in the United States.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44496
• EU PAS number:
  EUPAS22912
• Study ID:
  44496
• Official title and acronym:
  207221 - An observational, retrospective cohort database study to assess the safety of Boostrix (U.S. formulation), a reduced tetanus, diphtheria, acellular pertussis vaccine (Tdap), following routine immunization of pregnant women in the United States.
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The purpose of this study is to assess the safety of Boostrix administered on or after the first day of the 27th week of pregnancy by conducting a post-marketing study that will provide safety information to the public and healthcare providers. This will be one of the largest cohorts of pregnant women vaccinated with Boostrix in the U.S. Through partnership between Kaiser Permanente Southern California (KPSC) and the sponsor, GlaxoSmithKline (GSK), information about the safety of maternal vaccination with Boostrix and maternal and infant adverse events (AEs) in a community setting will be gained.
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Kaiser Permanente Southern California (KPSC)

Multiple centres: 7 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 19/12/2017

Study start date

Actual: 13/04/2018

Data analysis start date

Actual: 13/04/2018

Date of final study report

Actual: 15/03/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

gsk-207221-protocol-redact

Updated protocol

gsk-207221-protocol-redact-02

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable