Clinical trial NCT03463577: The Safety of Boostrix Following Routine Immunization of Pregnant Women
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Whooping Cough
Keywords: whooping cough, Boostrix, Tdap, safety, pregnancy, infants
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Kaiser Permanente
First posted: 2018-03-13
Enrollment: 65783
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 date

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 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.


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).

Primary outcomes:
measure: 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
timeFrame: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks
measure: 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
timeFrame: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks
measure: 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
timeFrame: From birth through 6 months of age
Secondary outcomes:
measure: 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
timeFrame: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks
measure: 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
timeFrame: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks
measure: 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
timeFrame: From birth through 6 months of age
measure: Incidence Rate (Per 1000 Person-years) of Women Adverse Events for Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy Group
timeFrame: For the Exposed cohort women-before 1st day of 27th week of pregnancy: from date of Boostrix vaccination until end of enrollment or pregnancy, whichever came first, up to 40 weeks
measure: Incidence Rate (Per 1000 Persons) of Women Adverse Events Presented for Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy Group
timeFrame: For the Exposed cohort women-before 1st day of 27th week of pregnancy: from date of Boostrix vaccination until end of enrollment or pregnancy, whichever came first, up to 40 weeks
measure: Incidence Rate (Per 1000 Persons) of Infant Adverse Events for Exposed Cohort Infants-before 1st Day of 27th Week of Pregnancy Group
timeFrame: From birth through 6 months of age
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: GSK Investigational Site
state: California
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: