Post-marketing surveillance to monitor the incidence of intussusception after large-scale vaccination with Reassortant Rotavirus Vaccine, Live, Oral, Pentavalent (Vero Cell) (ROTATEQ®) in Chinese infants using the Ningbo Regional Health Information Platform (NRHIP)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47560
• EU PAS number:
  EUPAS35812
• Study ID:
  47560
• Official title and acronym:
  Post-marketing surveillance to monitor the incidence of intussusception after large-scale vaccination with Reassortant Rotavirus Vaccine, Live, Oral, Pentavalent (Vero Cell) (ROTATEQ®) in Chinese infants using the Ningbo Regional Health Information Platform (NRHIP)
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  Rotavirus (RV) is the leading cause of severe diarrhea in infants and young children. In China, RV caused over 40% of diarrhea hospitalization and about 30% of diarrhea related outpatients visits in children aged < 5 years. Intussusception (IS) is a recognized and well-characterized safety concern in infants. The study objective was to assess the overall feasibility of conducting the study using the Ningbo Regional Health Information Platform (NRHIP), by assessing the IS diagnosis validity, the completeness of follow-up and the quality of linkage between the immunization register and Electronic Medical Records. The primary objective was to assess the incidence of IS (confirmed cases, Brighton Level 1) occurring within 3 months after vaccination with ROTATEQ® in Chinese infants. The secondary objectives were as follows: a) To describe the occurrence of IS (confirmed cases, Brighton Level 1) in the periods 1 to 7 days, 1 to 14 days, 1 to 21 days, 1 to 42 days and 1 day to 3 months following any dose of ROTATEQ ® in Chinese infants, b) to assess the incidence of IS (confirmed cases, Brighton Level 1) among Chinese infants in the same age range as the infants vaccinated with ROTATEQ® but did not receive any rotavirus vaccine, and c) to calculate the relative risk (RR) of IS in children vaccinated with ROTATEQ ® compared to children from the same birth cohort and within the same age range who did not receive any rotavirus vaccine.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Study timelines

Date when funding contract was signed

Actual: 11/06/2020

Study start date

Planned: 29/03/2021

Actual: 15/03/2021

Data analysis start date

Planned: 31/03/2022

Actual: 19/03/2022

Date of final study report

Planned: 20/05/2022

Actual: 20/05/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Study protocol

Initial protocol

V260-075-00-v3-China PMC_final redaction

Regulatory

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