N/A
Completed N=65,783
The Safety of Boostrix Following Routine Immunization of Pregnant Women
Whooping Cough
Source: ClinicalTrials.gov NCT03463577 ↗
Enrolled (actual)
65,783
Serious AEs
26.2%
Results posted
May 2022
Primary outcomePrimary: Incidence Rate (Per 1000 Person-years) of Pre-specified Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort-women Groups — 316.16; 219.00; 292.53; 207.35 Events per 1000 persons-year
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate (Per 1000 Person-years) of Pre-specified Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort-women Groups |
316.16; 219.00; 292.53; 207.35 | — |
| PRIMARY Incidence Rate (Per 1000 Persons) of Prespecified Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Women Groups |
64.63; 92.28 | — |
| PRIMARY Incidence Rate (Per 1000 Persons) of Pre-specified Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups |
80.42; 75.00 | — |
| SECONDARY Incidence Rate (Per 1000 Person-years) of Other Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Women Groups |
116.00; 137.63; 56.63; 44.59; 115.53; 141.52 | — |
| SECONDARY Incidence Rate (Per 1000 Persons) of Other Maternal Adverse Events for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Women Groups |
1.41; 2.41; 12.79; 12.02 | — |
| SECONDARY Incidence Rate (Per 1000 Persons) of Other Infant Adverse Events for Exposed Cohort infants-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Infants Groups |
0.92; 1.06; 2.81; 2.36; 69.85; 60.48 | — |
| SECONDARY Incidence Rate (Per 1000 Person-years) of Women Adverse Events for Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy Group |
354.50; 176.42; 119.75; 117.65 | — |
| SECONDARY Incidence Rate (Per 1000 Persons) of Women Adverse Events Presented for Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy Group |
15.38; 15.63; 46.88 | — |
| SECONDARY Incidence Rate (Per 1000 Persons) of Infant Adverse Events for Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy Group |
116.67; 88.24; 73.53; 14.71; 14.71; 44.12 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT03463577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.