A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2462 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-14

Study Completion Date

2017-05-31

Brief Summary

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The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in a maternal immunization program in Brazil.

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Detailed Description

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In this retrospective cohort study the safety of RefortrixTM (Tdap) administered during pregnancy as part of the National immunization program in Brazil will be assessed by comparing the risk of pre-defined adverse events before and after introduction of the RefortrixTM (Tdap) maternal immunization program.

Conditions

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Diphtheria

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Exposed cohort

Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).

Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]

Intervention Type BIOLOGICAL

Subjects were included in the Exposed cohort if they received Refortrix as part of the maternal immunization program in Brazil.

Unexposed cohort

Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.

Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]

Intervention Type BIOLOGICAL

Subjects were included in the Exposed cohort if they received Refortrix as part of the maternal immunization program in Brazil.

Interventions

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Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]

Subjects were included in the Exposed cohort if they received Refortrix as part of the maternal immunization program in Brazil.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects between 18 and 45 years of age at the time of pregnancy under consideration for the study, who deliver in the study centre.
* Residents of the study area
* Subjects who were compliant with the routine antenatal care including at least one ultrasound assessment report early in the pregnancy.
* Subjects with the complete and relevant medical records available.

* Subjects who received one dose of Refortrix vaccine in the recommended time period between 27 and 36 completed weeks of pregnancy (or as late as 20 days before delivery due date) as part of the maternal immunization program in Brazil, and according to the program recommendations from May 2015 onwards.
* Subjects with appropriate vaccination records.

* Subjects who had delivered in the same hospital (study centre) before 01 September 2014 (September 2012-August 2014) and who did not receive Tdap vaccination during pregnancy to the best knowledge of the investigator.

Exclusion Criteria

* Subjects who have been transferred to other specialised centres, where their medical records would be inaccessible for the study (private clinics, psychiatric or prison hospitals, other state hospitals, etc).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No