The Safety of Boostrix Following Routine Immunization of Pregnant Women
NCT ID: NCT03463577
Last Updated: 2022-05-18
Study Results
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View full resultsBasic Information
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COMPLETED
65783 participants
OBSERVATIONAL
2018-04-13
2020-08-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Exposed cohort women-on or after 1st day of 27th week of pregnancy
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.
Safety assessment following routine immunization with Boostrix
Subject-level data was collected for pregnant women and their infants through the Electronic Health Records.
Unexposed historical cohort women
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.
Safety assessment following routine immunization with Boostrix
Subject-level data was collected for pregnant women and their infants through the Electronic Health Records.
Exposed cohort women-before 1st day of 27th week of pregnancy
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.
Safety assessment following routine immunization with Boostrix
Subject-level data was collected for pregnant women and their infants through the Electronic Health Records.
Exposed cohort infants-on or after 1st day of 27th week of pregnancy
This group consisted of infants whose mothers belong to Exposed cohort women-on or after 1st day of 27th week of pregnancy group.
Safety assessment following routine immunization with Boostrix
Subject-level data was collected for pregnant women and their infants through the Electronic Health Records.
Unexposed historical cohort infants
This group consisted of infants whose mothers belong to the Unexposed historical cohort women group.
Safety assessment following routine immunization with Boostrix
Subject-level data was collected for pregnant women and their infants through the Electronic Health Records.
Exposed cohort infants-before 1st day of 27th week of pregnancy
This group consisted of infants whose mothers belong to the Exposed cohort women-before 1st day of 27th week of pregnancy group.
Safety assessment following routine immunization with Boostrix
Subject-level data was collected for pregnant women and their infants through the Electronic Health Records.
Interventions
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Safety assessment following routine immunization with Boostrix
Subject-level data was collected for pregnant women and their infants through the Electronic Health Records.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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).
FEMALE
Yes
Sponsors
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Kaiser Permanente
OTHER
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Pasadena, California, United States
Countries
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References
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Florea A, Sy LS, Ackerson BK, Qian L, Luo Y, Becerra-Culqui T, Lee GS, Tian Y, Zheng C, Bathala R, Tartof SY, Campora L, Ceregido MA, Kuznetsova A, Poirrier JE, Rosillon D, Valdes L, Cheuvart B, Mesaros N, Meyer N, Guignard A, Tseng HF. Investigating Tetanus, Diphtheria, Acellular Pertussis Vaccination During Pregnancy and Risk of Congenital Anomalies. Infect Dis Ther. 2023 Feb;12(2):411-423. doi: 10.1007/s40121-022-00731-8. Epub 2022 Dec 15.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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207221
Identifier Type: -
Identifier Source: org_study_id
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