An OTIS/MotherToBaby Pregnancy Registry-based observational cohort study to evaluate pregnancy and infant outcomes in individuals exposed to Boostrix as of the 1st day of the 27th week of gestation in the US (EPI-PERTUSSIS-075 VS US PR 219588)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105108
• EU PAS number:
  EUPAS105107
• Study ID:
  105108
• Official title and acronym:
  An OTIS/MotherToBaby Pregnancy Registry-based observational cohort study to evaluate pregnancy and infant outcomes in individuals exposed to Boostrix as of the 1st day of the 27th week of gestation in the US (EPI-PERTUSSIS-075 VS US PR 219588)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study aims to determine whether risks of pregnancy and neonatal or early infancy safety outcomes are higher among pregnant people after receiving the Boostrix (Tdap) vaccine on or after the 1st day of the 27th week of pregnancy versus the non-vaccinated.
• Study status:
  Ongoing

Research institution and networks

Institutions

University of California

Networks

Organization of Teratology Information Specialists (OTIS) Network

Study timelines

Date when funding contract was signed

Actual: 19/05/2023

Study start date

Planned: 20/06/2023

Actual: 20/06/2023

Date of final study report

Planned: 19/12/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

Protocol_Anonymized

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable