NCT02757950

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,462 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

• Diphtheria

Interventions

Type	Name	Description
BIOLOGICAL	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.

Timeline

• Start date: 2016-07-14
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2016-05-02
• Last updated: 2019-10-01
• Results posted: 2019-10-01

Locations

1 site across 1 country: Brazil