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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Intussusception

Population studied

• Short description of the study population:
  The study population is defined as all infants aged 6 to 45 weeks from December 2018 to June 2021 from the NRHIP immunization register, including infants vaccinated with ROTATEQ® (“vaccinated infants”) as well as infants from the same birth cohorts, who received at least one type 1 vaccine but no rotavirus vaccine (“unvaccinated infants”).; ; Inclusion criteria; • All infants aged 6 to 45 weeks from December 2018 to June 2021 from the NRHIP immunization register.; • Infants who received at least one dose of ROTATEQ® at age 6 to 12 weeks as recorded in the NRHIP immunization register will be considered vaccinated infants;; • Infant from the same birth cohort as the “vaccinated infants” who received at least one dose of a type 1 childhood vaccines but no rotavirus vaccine as recorded in the NRHIP immunization register will be considered unvaccinated infants.; ; Exclusion criteria; • Vaccinated infants:; o Infants with IS before they received the first dose of ROTATEQ®;; o Infants who were vaccinated out of the indicated age schedule, i.e., who received a first vaccine dose before 6 weeks or after 12 weeks of age and/or any dose; after 32 weeks of age;; o Infants who received one or more doses of LLR or any other RV vaccines in addition to ROTATEQ® during the study period;; o Infants without any recorded type 1 vaccination at age 8 to 9 months or until their individual end of follow-up three months after their last ROTATEQ® dose (whatever comes first) as those infants are considered to be lost to follow-up.; • Unvaccinated infants; o Infants with IS prior to 6 weeks of age;; o Infants without any recorded type 1 vaccination at age 8 to 9 months are considered to be lost to follow-up.
• Age groups:
  Infants and toddlers (28 days – 23 months)
• Estimated number of subjects:
  61716

Study design details

• Main study objective:
  To assess the incidence of IS (confirmed cases, Brighton Level 1) occurring within 3 months after vaccination with ROTATEQ® in Chinese infants.
• Outcomes:
  The incidence of IS (confirmed cases, Brighton Level 1) occurring within 3 months after vaccination with ROTATEQ® in Chinese infants. 1. Occurrence of IS 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 ® 2. Incidence of IS in the same age range as the infants vaccinated with ROTATEQ® but did not receive any rotavirus vaccine. 3. Relative risk (RR) of IS in children vaccinated with ROTATEQ ® compared to similar children who did not receive any rotavirus vaccine.
• Data analysis plan:
  The incidence of intussusception (IS) occurring within 3 months after vaccination with ROTATEQ® will be estimated. The occurrence of IS cases will be described with respect to the time-interval post-vaccination and in relation to dose number. We will compare the incidence rate (per 100,000 person-years) of IS in vaccinated infants to unvaccinated infants during the concurrent period (December 2018 to June 2021).

Documents

Study results

V260-075-CSR_final redaction