Status:
COMPLETED
The Safety of Boostrix Following Routine Immunization of Pregnant Women
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Kaiser Permanente
Conditions:
Whooping Cough
Eligibility:
FEMALE
Brief 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 informatio...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Pregnant women with prenatal care and continuous membership (allowing up to a 31-day gap) at KPSC between the 1st day of the 27th week of pregnancy and the index (vaccination) date.
- Exposed cohort (from the 27th week of gestation): Pregnant women vaccinated with Boostrix on or after the 1st day of the 27th week of pregnancy; who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy in scope of this study.
- Unexposed cohort: Women matched to the exposed cohort and pregnant sometime during the approximate estimated period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy in scope of this study.
- For the analysis of congenital anomalies among live births, at birth and through six months of age, the following additional inclusion criteria for infants will be applied:
- Live born
- Born in KPSC hospitals
- Note: Pregnant women vaccinated with Boostrix during pregnancy before the 27th week of gestation, with membership at the date of vaccination, and who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy in scope of this study will be part of a descriptive analysis (secondary objective).
Exclusion
Key Trial Info
Start Date :
April 13 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 4 2020
Estimated Enrollment :
65783 Patients enrolled
Trial Details
Trial ID
NCT03463577
Start Date
April 13 2018
End Date
August 4 2020
Last Update
May 18 2022
Active Locations (1)
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1
GSK Investigational Site
Pasadena, California, United States, 91101