Postmarketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age

Study type

• Study topic:
  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:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BB03) influenza, live attenuated

  influenza, live attenuated

Population studied

• Short description of the study population:
  Individuals aged 2 through 49 years (prior to 50th birthday) at the time of vaccination (or index date for unvaccinated controls) who had membership in the Kaiser Permanente (KP) Health Care Plan for at least 12 months prior to vaccination/index date and continuous enrollment in the KP Health Care Plan through 6 months following vaccination/index date.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Estimated number of subjects:
  80000

Study design details

• Main study objective:
  To assess the safety of Q/LAIV vaccination in children and adults 2 through 49 years of age within 180 days after vaccination
• Outcomes:
  Rates of medically attended events from 0 to 3 days: hypersensitivity, seizures/convulsionsRates of medically attended events from 1 to 42 days: lower respiratory tract infection, wheezing, Guillain-Barré syndrome, Bell’s palsy, encephalitis, neuritis, vasculitis, any hospitalization and respiratory hospitalizationsRates of medically attended events from 1 to 180 days: narcolepsy/cataplexy
• Data analysis plan:
  Incidence rates of adverse events of interest during periods at risk after quadrivalent live attenuated influenza vaccine (Q/LAIV) vaccination will be compared to incidence rates during reference periods later in the follow-up (within-cohort analysis) and to incidence rates in controls (matched unvaccinated subjects and matched inactivated vaccine recipients).Relative risks (RR) and corresponding 95% confidence intervals (CIs) will be constructed for each event for safety comparisons with control groups. Crude RR and adjusted hazard ratio (HR) and corresponding 95% CIs for each event will be derived.Crude RR and exact 95% CI will be calculated without adjustment of any covariate. Adjusted HR and corresponding 95% CI will be obtained using Cox proportional hazards model with calendar time data input adjusting for seasonal changes in background rates and other confounders.

Documents

Study results

MEDI1115 CSR Synopsis FINAL 02Sept2016