201889 - Planned analyses related to the Post-Authorization Safety Study (PASS) of Post-Marketing Surveillance for Intussusception following Rotarix introduction into the Instituto Mexicano del Seguro Social (IMSS) in Mexico.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31674
• EU PAS number:
  EUPAS6110
• Study ID:
  31674
• Official title and acronym:
  201889 - Planned analyses related to the Post-Authorization Safety Study (PASS) of Post-Marketing Surveillance for Intussusception following Rotarix introduction into the Instituto Mexicano del Seguro Social (IMSS) in Mexico.
• DARWIN EU® study:
  No
• Study countries:
  Belgium
• Study description:
  The aim of these planned analyses linked to Post-Authorization Safety Study (PASS) was to assess the risk of Intussusception after the 1st and the 2nd dose of Rotarix and Rotateq vaccines and provide an overall estimate of the risk after each dose by combining results from different studies using meta-analysis method.Please refer also to the summary of the initial PASS study, submitted to this registry as a separate study entitled "Post-Authorization Safety Study (PASS) of Post-Marketing Surveillance for Intussusception Following Rotarix Introduction into the Instituto Mexicano del Seguro Social (IMSS) in Mexico".
• Study status:
  Finalised

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Actual: 07/06/2013

Study start date

Actual: 08/06/2013

Date of final study report

Actual: 05/07/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline Biologicals

Study protocol

Initial protocol

104435-Additional-analysis-redact

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)