Post-marketing study to assess the risk of intussusception after immunization with GlaxoSmithKline (GSK) Biologicals’ oral live-attenuated human rotavirus vaccine in infants less than 1 year old in Latin America (212329)

Study identification

• EU PAS number:
  EUPAS1000000701
• Study ID:
  1000000701
• Official title and acronym:
  Post-marketing study to assess the risk of intussusception after immunization with GlaxoSmithKline (GSK) Biologicals’ oral live-attenuated human rotavirus vaccine in infants less than 1 year old in Latin America (212329)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Colombia

  Dominican Republic

  Honduras

  Mexico

  Panama
• Study status:
  Planned

Research institutions and networks

Institutions

GlaxoSmithKline (GSK)

Study timelines

Date when funding contract was signed

Planned:20/06/2025

Actual:04/03/2025

Study start date

Planned:17/11/2025

Date of final study report

Planned:13/03/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline Biologicals

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable