The Safety of Boostrix Following Routine Immunization of Pregnant Women
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 15 - 45 |
| Updated: | 6/10/2018 |
| Start Date: | April 13, 2018 |
| End Date: | April 30, 2020 |
| Contact: | US GSK Clinical Trials Call Center |
| Email: | GSKClinicalSupportHD@gsk.com |
| Phone: | 877-379-3718 |
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
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 in a community setting will be gained.
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 in a community setting will be gained.
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: 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 1/1/2012-12/31/2013 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
Exclusion Criteria:
- Pregnant women will be analytically excluded from the primary analysis if they are
"high risk." High-risk conditions include the following:
- Age at pregnancy start <15 or >45 years
- Autoimmune disorder (systemic lupus erythematosus, mixed connective tissue disease)
- Cervical incompetence
- Multiple gestation
- Rh sensitization
- Thyroiditis
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