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The Safety of Boostrix Following Routine Immunization of Pregnant Women

NCT03463577 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 65783

Last updated 2022-05-18

Study results available
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Summary

The purpose of this study was 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 provided safety information to the public and healthcare providers. This was 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 was gained.

Conditions

Interventions

OTHER

Safety assessment following routine immunization with Boostrix

Subject-level data was collected for pregnant women and their infants through the Electronic Health Records.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-13
Primary Completion
2020-08-04
Completion
2020-08-04

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03463577 on ClinicalTrials.gov