Observational study to assess effectiveness of ROTATEQ® against acute gastroenteritis (AGE) due to rotavirus (regardless of type) and by type in China

Study identification

• EU PAS number:
  EUPAS1000000734
• Study ID:
  1000000734
• Official title and acronym:
  Observational study to assess effectiveness of ROTATEQ® against acute gastroenteritis (AGE) due to rotavirus (regardless of type) and by type in China
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  This study aims to leverage the dataset of the ROTATEQ® vaccine effectiveness (VE) post-licensure study in China (Protocol V260-077) to assess the VE of ROTATEQ® against rotavirus acute gastroenteritis (RVGE) (regardless of type), as well as type-specific VE against individual RV type (including non-vaccine types). ; The main objective of this study is to assess the effectiveness of ROTATEQ® against all types of RVGE in children treated in the hospital for acute gastroenteritis (AGE).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Merck Sharpe & Dohme LLC

Study timelines

Date when funding contract was signed

Actual:16/11/2023

Study start date

Actual:31/08/2025

Data analysis start date

Actual:30/09/2025

Date of final study report

Planned:01/01/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Regulatory

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