Trials / Completed
CompletedNCT03463577
The Safety of Boostrix Following Routine Immunization of Pregnant Women
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 65,783 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| OTHER | Safety assessment following routine immunization with Boostrix | Subject-level data was collected for pregnant women and their infants through the Electronic Health Records. |
Timeline
- Start date
- 2018-04-13
- Primary completion
- 2020-08-04
- Completion
- 2020-08-04
- First posted
- 2018-03-13
- Last updated
- 2022-05-18
- Results posted
- 2022-05-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03463577. Inclusion in this directory is not an endorsement.