203153 - 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

Study identification

• EU PAS number:
  EUPAS13406
• Study ID:
  32381
• Official title and acronym:
  203153 - 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
• DARWIN EU® study:
  No
• Study countries:
  Brazil
• Study description:
  The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in a maternal immunization program in Brazil. 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Hospital Municipal de São Bernardo do Campo

Study timelines

Date when funding contract was signed

Actual:21/09/2015

Study start date

Actual:14/07/2016

Date of final study report

Actual:13/03/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline Biologicals

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)