The objective of this postmarketing study was to conduct a broad assessment of LAIV safety, Crizotinib evaluating all events and specific prespecified events. The current analysis describes the results among adults 18–49 years of age; results for children will be reported separately. This study was conducted in the Kaiser Permanente (KP) Health Plans of Northern California, Hawaii, and Colorado, where membership totals approximately 4 million individuals. Through KP immunization registries, approximately 20,000 individuals 18–49 years

of age who were immunized from the 2003–2004 to 2007–2008 influenza seasons with LAIV as part of routine clinical practice were identified. The study’s objective was to assess the safety of LAIV by comparing the rates of medically attended events (MAEs) in LAIV recipients (all MAEs by diagnosis

and specifically serious adverse events [SAEs], anaphylaxis, urticaria, asthma, wheezing, prespecified diagnoses of interest, and rare events potentially related to wild-type influenza) to the rates in 3 non-randomized control groups. Commercially www.selleckchem.com/products/OSI-906.html available LAIV was supplied by MedImmune, and commercially available TIV was purchased by KP as part of routine practice. Each annual formulation of the vaccines contained the strains recommended for inclusion by the U.S. Public Health Service. Subjects were screened for underlying medical conditions and provided the appropriate vaccine based on the eligibility criteria in each vaccine’s package insert, physician discretion, and patient choice. Study subjects with high-risk underlying medical

conditions such as cancer, organ transplantation, diabetes, endocrine and metabolic disorders, blood disorders, liver disorders, kidney disorders, and cardiopulmonary disorders (for whom LAIV was not recommended) were identified via automated extraction of health care databases and excluded from all analysis cohorts. The protocol was reviewed and approved by the KP Institutional Review Board. Three nonrandomized control groups were identified for Terminal deoxynucleotidyl transferase comparison: a within-cohort (i.e., self-controlled) control, matched concurrent unvaccinated controls, and matched concurrent TIV recipient controls. For the within-cohort analysis, LAIV recipients served as their own controls based on the observation time after vaccination. Risk intervals of 3 and 21 days postvaccination were compared with control intervals from 4–42 days postvaccination (for the 3-day risk interval) and 22–42 days postvaccination (for a 0- to 21-day risk interval). Controls were matched 1:1 with LAIV recipients. If a match could not be found within a specific control group, the LAIV recipient was excluded from the cohort comparison. Unvaccinated controls were KP members who participated in the health plan during the same month as the reference LAIV recipient; for the unvaccinated population, the effective vaccination date was the date on which the matched LAIV recipient was vaccinated.