Background rates of disease in Latin American children in view of future vaccine safety assessment

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Baseline rates
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Secondary use of a randomized clinical trial i.e. GSK Rotarix study 023.

Study drug and medical condition

• Name of medicine:
  ROTARIX
• Medical condition to be studied:
  Diarrhoea

  Vomiting

  Dehydration

  Hypovolaemic shock

  Pneumonia

  Seizure like phenomena

Population studied

• Short description of the study population:
  Healthy infants from 11 Latin American countries and Finland.
• Age groups:
  • Paediatric Population (< 18 years)

    • Infants and toddlers (28 days – 23 months)
• Estimated number of subjects:
  63225

Study design details

• Main study objective:
  To define background rates of disease in Latin American children
• Outcomes:
  Incidence rates (/100.000 person years) for a list of selected medical events grouped by system organ class (MedDRA)
• Data analysis plan:
  Incidence rates for selected medical events (MedDRA) will be calculated for Latin America overall, as well as country- and sex-specific incidence rates. Data from both study arms of the GSK study 023 will be combined as in ‘real-life’ vaccinated and unvaccinated subpopulations co-exist and furthermore, no significant risk differences in the selected medical events between vaccinated and unvaccinated children were detected in this study. If possible, 95% CI based on the assumption of a Poisson distribution for event counts will be calculated. If the number of cases is sufficiently large, age- and if applicable, season-specific incidence rates will be calculated as well. Because of the longitudinal follow-up of the 023 study, the presence of repeated and/or correlated events will be investigated and appropriate statistical measures taken, if needed. The results will be summarized in a Table. All statistical analyses will be conducted using SAS.