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

NCT02757950 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2462

Last updated 2019-10-01

Study results available
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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.

Conditions

  • Diphtheria

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-14
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02757950 on ClinicalTrials.gov