At a glance
ClinicalIndex Comparison RecordN/ACompleted· 2,462 enrolled
Drug / intervention
Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
An observational study evaluating Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)] for Diphtheria. Completed, enrolled 2,462 participants across 1 site.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria
CountriesBrazil
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartJul 2016
Primary CompletionMay 2017
TodayJul 2026
First PostedMay 2, 2016
Enrollment StartJul 14, 2016
Primary CompletionMay 31, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.2 years ago
Interventions
Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]biological
Subjects were included in the Exposed cohort if they received Refortrix as part of the maternal immunization program in Brazil.