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

Other

Non-interventional study design, other

Prospective cohort
Study drug and medical condition

Name of medicine

FLUENZ

Medical condition to be studied

Asthma
Diabetes mellitus
Cystic fibrosis
Population studied

Short description of the study population

Children 2 to 17 years of age who have high-risk underlying medical conditions.
Following Patients were included:
1. Age 2 through 17 years (prior to 18th birthday) of age at date of vaccination or index date
2. Evidence of a diagnosis of at least one of the following high-risk underlying medical conditions:
Asthma, Cystic fibrosis, Congenital lung abnormalities, Heart disease (significant congenital, valvular, and/or rheumatic heart disease), Renal disease (glomerulonephritis, chronic or congenital kidney disease), Sickle cell anemia, White blood cell disorders, Immunosuppressive disorders (excluding malignancy), Malignancy, Diabetes mellitus, Lipid metabolism disorders, Cerebral palsy, Down syndrome, Any medical condition being treated with chronic aspirin therapy, Pregnancy

Age groups

  • Paediatric Population (< 18 years)
    • Adolescents (12 to < 18 years)
    • Children (2 to < 12 years)

Special population of interest

Hepatic impaired
Immunocompromised
Renal impaired

Estimated number of subjects

10000
Study design details

Main study objective

to assess the safety of FLUENZ in regard to rates of serious adverse events (SAEs) relative to matched trivalent inactivated influenza vaccine (TIV) recipients, matched unvaccinated comparison groups, and within cohort (a self-controlled analysis) among children 2 to 17 years of age who have high-risk underlying medical conditions.

Outcomes

Rate of serious adverse events, rates of lower respiratory serious adverse events and other incident medically attended events of interest among FLUENZ recipients relative to comparison groups

Data analysis plan

Incidence rates were reported as number of subjects with an incident event per 1,000 person-years. If a subject had more than one event in the time period, only the incident event was counted and the child censored afterwards.When comparing LAIV recipients with matched IIV recipients or unvaccinated controls, relative risks, and corresponding 95% confidence intervals (CI) were estimated using conditional Cox proportional hazards models. A period effect defined as a time-varying covariate was added to the model for within-cohort analyses.