Effectiveness of ROTATEQ® when administered with intervals greater than 10 weeks between doses in Chinese children: an observational study of V260-077 study participants with longer dosing interval (V260-080)

Study identification

• EU PAS number:
  EUPAS1000000730
• Study ID:
  1000000730
• Official title and acronym:
  Effectiveness of ROTATEQ® when administered with intervals greater than 10 weeks between doses in Chinese children: an observational study of V260-077 study participants with longer dosing interval (V260-080)
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  The main objective of the study is to assess the vaccine effectiveness of ROTATEQ® against all types of rotavirus acute gastroenteritis (RVGE) when administered in Chinese children with at least one dosing interval of greater than 10 weeks between doses 1 and 2 and/or 2 and 3.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Merck Sharpe & Dohme LLC, Hangzhou Tigermed Consulting Co.,Ltd

Study timelines

Date when funding contract was signed

Planned:16/11/2023

Actual:16/11/2023

Study start date

Planned:31/08/2025

Actual:22/09/2025

Data analysis start date

Planned:30/09/2025

Actual:30/09/2025

Date of final study report

Planned:31/01/2026

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