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

CompletedOBSERVATIONAL

Enrollment

2,462

Participants

Timeline

Start Date

July 14, 2016

Primary Completion Date

May 31, 2017

Study Completion Date

May 31, 2017

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.

Trial Locations (1)

GSK Investigational Site, Santo André