Post-marketing study to assess serotype-specific effectiveness of Reassortant Rotavirus Vaccine, Live, Oral, Pentavalent (Vero Cell) (ROTATEQ®) in China (V260-077)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48721
• EU PAS number:
  EUPAS36666
• Study ID:
  48721
• Official title and acronym:
  Post-marketing study to assess serotype-specific effectiveness of Reassortant Rotavirus Vaccine, Live, Oral, Pentavalent (Vero Cell) (ROTATEQ®) in China (V260-077)
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  In clinical trials and post-marketing studies abroad, ROTATEQ® demonstrated consistently high efficacy and effectiveness against severe rotavirus (RV) gastroenteritis (RVGE) of >90%. Serotype specific efficacy and effectiveness against genotypes G2P4, G3P8 and G4P8 was > 80% in those studies. ; However, in the China Phase 3 trial, serotype-specific efficacy was only demonstrated for RV serotypes G1 and G9, and not for G2, G3 and G4 because those serotypes were not circulating in the study region during the period when the study was performed.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Merck & Co.

Merck Sharp & Dohme Rahway, New Jersey

Study timelines

Date when funding contract was signed

Planned: 22/11/2019

Actual: 31/03/2020

Study start date

Planned: 30/09/2020

Actual: 16/09/2020

Data analysis start date

Planned: 30/04/2025

Actual: 19/04/2025

Date of final study report

Planned: 30/04/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Study protocol

Initial protocol

V260-077-00-v2-China PMC-Prot_Final Redaction Part 1 Pages 1-28

Updated protocol

V260-077-V6.0-final-redaction.pdf

Regulatory

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