The Safety of Boostrix Following Routine Immunization of Pregnant Women

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Whooping Cough

Treatments

Other: Safety assessment following routine immunization with Boostrix

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT03463577

207221

Details and patient eligibility

About

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.

Enrollment

65,783 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

65,783 participants in 6 patient groups

Exposed cohort women-on or after 1st day of 27th week of pregnancy

Description:

This group consisted of pregnant women who received the Tdap vaccine (Boostrix) on or after the 1st day of the 27th week of pregnancy during the period January 1, 2018 to January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy.

Treatment:

Other: Safety assessment following routine immunization with Boostrix

Unexposed historical cohort women

Description:

This group consisted of women matched to Exposed cohort women-on or after 1st day of 27th week of pregnancy group and pregnant at least one day during the historical period between January 1, 2012-December 31, 2014 and did not receive any Tdap vaccine during the pregnancy.

Treatment:

Other: Safety assessment following routine immunization with Boostrix

Exposed cohort women-before 1st day of 27th week of pregnancy

Description:

This group consisted of pregnant women who received the Tdap vaccine (Boostrix) before the 1st day of the 27th week of pregnancy during the period January 1, 2018-January 31, 2019 who were not vaccinated with any other Tdap vaccine at any other time during the pregnancy.

Treatment:

Other: Safety assessment following routine immunization with Boostrix

Exposed cohort infants-on or after 1st day of 27th week of pregnancy

Description:

This group consisted of infants whose mothers belong to Exposed cohort women-on or after 1st day of 27th week of pregnancy group.

Treatment:

Other: Safety assessment following routine immunization with Boostrix

Unexposed historical cohort infants

Description:

This group consisted of infants whose mothers belong to the Unexposed historical cohort women group.

Treatment:

Other: Safety assessment following routine immunization with Boostrix