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FluMist for children < 5 years of age STATISTICAL DISCUSSION of SAFETY based on MI-CP111

FluMist for children < 5 years of age STATISTICAL DISCUSSION of SAFETY based on MI-CP111. Sang H. Ahnn, Ph.D. CBER/FDA VRBPAC May 16, 2007 Gaithersburg, MD. MI-CP111. A multi-center, double-blind, randomized study to compare the efficacy and safety of FluMist vs. TIV.

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FluMist for children < 5 years of age STATISTICAL DISCUSSION of SAFETY based on MI-CP111

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  1. FluMistforchildren < 5 years of ageSTATISTICAL DISCUSSION of SAFETY based on MI-CP111 Sang H. Ahnn, Ph.D. CBER/FDA VRBPAC May 16, 2007 Gaithersburg, MD

  2. MI-CP111 • A multi-center, double-blind, randomized study to compare the efficacy and safety of FluMist vs. TIV. • 8,475 (4,117 in the U.S.) subjects randomized (1:1 ratio) to either FluMist or TIV, stratified by: ~ age (6-23 months, 24-35 months, 36-59 months) ~ prior influenza vaccination (yes/no) ~ wheezing history status (≥ 3 wheezing illnesses requiring medical follow-up or hospitalization: yes/no) ~ country.

  3. MI-CP111 • MI-CP111 was performed in children 6-59 months of age, including those with a history of wheezing or asthma. • Children with medically-diagnosed or treated wheezing within 42 days before enrollment or with history of severe asthma were excluded • The applicant is seeking an indication extension of FluMist for children 12-59 months of age, excluding those children with a history of wheezing or asthma.

  4. Three uses of Wheezing History in MI-CP111 • Exclusion criterion: Subjects with medically-diagnosed or treated wheezing within 42 days before enrollment or with history of severe asthma were excluded from the study • Stratum (for randomization):Subjects with ≥ 3 wheezing illnesses requiring medical follow-up or hospitalization is a pre-specified subgroup within which subjects were randomized • Post hoc subgroup:Subjects with a history of wheezing is a post-hoc, non-randomized subgroup

  5. MI-CP111 Safety Results (Safety population) Relative Risk of FluMist to TIV Based on Medically Significant Wheezing* (MSW) *Occurring through 42 days after vaccination

  6. MI-CP111 Safety Results on Safety population Relative Risk of FluMist to TIV Based on Medically Significant Wheezing-related Hospitalization* *Medically significant wheezing (MSW) –related hospitalizations comprise hospitalizations within 7 days after MSW, provided that the MSW event occurred within 42 days after vaccination

  7. Exclusion of 6-11 Month-olds The applicant stated “In children 6-11 months of age, rates of medically significant wheezing and rates of hospitalizations were higher in FluMist vs. TIV recipients.” This result is the basis for the applicant excluding the 6-11 month subgroup from the sought indication.

  8. MI-CP111 Safety Results (Safety population) Relative Risk of FluMist to TIV Based on Medically Significant Wheezing* (MSW) *Occurring through 42 days after vaccination

  9. MI-CP111 Safety Results (Safety population) Relative Risk of FluMist to TIV Based on Medically Significant Wheezing-related Hospitalization* * Medically significant wheezing (MSW) –related hospitalizations comprise hospitalizations within 7 days after MSW, provided that the MSW event occurred within 42 days after vaccination

  10. Per the preceding two tables, in the FluMist group compared to TIV, rates of medically significant wheezing and MSW-related hospitalizations were not only higher in children 6-11 months of age, but also higher in those 12-23 months of age.

  11. SUMMARY • In general, since the 6-11 month age group (12-23 month group likewise) is a post-hoc, non-randomized subgroup, statistical results could be misleading and therefore should be interpreted with caution. • Specifically, in terms of MSW and MSW-related hospitalization, 6-11 months, and 12-23 months subgroups show similar safety profiles. • Thus, statistical rationale for excluding 6-11 months group and not entire 6-23 months group appears unclear.

  12. MI-CP111 Safety Results (Safety population) Relative Risk of FluMist to TIV Based on Medically Significant Wheezing* (MSW) (excluding subjects w/ hx of wheezing/asthma)

  13. MI-CP111 Safety Results on Safety population Relative Risk of FluMist to TIV Based on Medically Significant Wheezing-related Hospitalization* (excluding subjects w/ hx of wheezing/asthma)

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