201889 - Planned analyses related to the Post-Authorization Safety Study (PASS) of Post-Marketing Surveillance for Intussusception following Rotarix introduction into the Instituto Mexicano del Seguro Social (IMSS) in Mexico.

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
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

• Name of medicine:
  ROTARIX

  ROTATEQ
• Medical condition to be studied:
  Intussusception

Population studied

• Short description of the study population:
  Subjects (more than 6 weeks of age) vaccinated with Rotarix and Rotateq vaccines.
• Age groups:
  Infants and toddlers (28 days – 23 months)
• Estimated number of subjects:
  1

Study design details

• Main study objective:
  To provide a single estimate of the relative risk of IS after the 1st and the 2d dose of Rotarix.To provide a single estimate of the relative risk of IS after the 1st and the 2d dose of Rotateq.
• Outcomes:
  Relative risk of Intussusception (IS) following the 1st and the 2nd dose of Rotarix and Rotateq vaccines during the 7 days (Day 0 - Day 6) after vaccination.
• Data analysis plan:
  Two analyses were done- Main analysis including the 6 above-referred publications,- A sensitivity analysis including in addition, Weinstrub et al. 2014.Studies which met the following criteria were included in the main analysis:- Post-marketing studies (no clinical trials),- Risk estimated for the 7-day period after vaccination,- Risk estimated for dose 1 and dose 2, separately,- Data obtained through active and/or passive surveillance on “confirmed” IS cases (Brighton or other method of case adjudication),- Full report or publication available.There was one sensitivity analysis conducted:- Analysis included only SCCS, SCRI and case-control designs.The analyses were done using the risk estimates and its 95% confidence intervals (CI) reported in the publications or reports. No raw data were used.Analyses were done separately for Rotarix and Rotateq.

Documents

Study results

104435-SAR E01_16-V1