Background rates of disease in Latin American children in view of future vaccine safety assessment

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/19623
• EU PAS number:
  EUPAS8502
• Study ID:
  19623
• Official title and acronym:
  Background rates of disease in Latin American children in view of future vaccine safety assessment
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Brazil

  Chile

  Colombia

  Dominican Republic

  Finland

  Honduras

  Mexico

  Nicaragua

  Panama

  Peru

  Venezuela, Bolivarian Republic of
• Study description:
  Estimates of background rates of potential adverse events are an essential part of monitoring and assessing possible vaccine safety concerns (1). Accurate background rates are needed to allow distinguishing genuine safety concerns from events that are temporarily associated but not causally linked to vaccination. GlaxoSmithKline (GSK) has carried out one of the largest trials in Latin America to assess the safety and efficacy of the Rotavirus vaccine (Study 023). A total of 63,225 healthy infants from 11 Latin American countries and Finland, divided over a study arm (receiving two oral doses of the human rotavirus vaccine (Rotarix, GSK) 31,673 infants) or a control arm (receiving two doses of placebo, 31,552 infants) were followed-up to investigate the safety and efficacy of the vaccine (2). Serious adverse events were captured by an active-surveillance system in all medical facilities. Outcomes were recaptured during the scheduled visits, if missed by the active-surveillance system. This trial offers a unique opportunity to increase our knowledge on the background rates of selected medical events in this region.
• Study status:
  Finalised

Research institutions and networks

Institutions

P95 Clinical and Epidemiology Services

Belgium

Colombia

Netherlands

South Africa

Thailand

United States

Study timelines

Date when funding contract was signed

Planned: 18/03/2014

Actual: 18/03/2014

Study start date

Planned: 02/02/2015

Actual: 02/02/2015

Date of final study report

Planned: 01/07/2017

Actual: 01/06/2017

Sources of funding

Other

More details on funding

P95

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable