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The National Advisory Committee on Immunization (NACI) has updated its recommendations on the use of live attenuated influenza vaccine (LAIV) (Flumist® Quadrivalent. The typical flu season occurs from fall to early spring. The length and severity of an epidemic may vary. Some lucky individuals can get through the season flu-free. Study FM0. 26b) Age. Number of Subjects. Sheddingc. Peak Titer (TCID5. L)d Shedding After Day 1. Day of Last Positive Culture. Day 2. 3f. 24- 5. Day 2. 5g. 5- 8 years. Day 2. 3h. 9- 1. 7 years. Day 2. 8h. 18- 4. Day 1. 7ha NCT0. 03. NCT0. 01. 92. 14. Proportion of subjects with detectable virus at any time point. Peak titer at any time point during the 2. Flu. Mist and Flu. Mist Quadrivalent are not approved for use in. After Day 1. 1 among. TCID5. 0/m. L. Studies In Immunocompromised Individuals. Safety and shedding of vaccine virus following Flu. Mist. administration were evaluated in 2. HIV- infected adults . No. serious adverse events were reported during the one- month follow- up period. Frequency. and duration of vaccine virus shedding in HIV- infected individuals were. No adverse effects on HIV viral. CD4 counts were identified following Flu. Mist administration. In the 5. through 1. Flu. Mist recipient experienced pneumonia within 2. The effectiveness of Flu. Mist and Flu. Mist Quadrivalent. HIV- infected individuals has not been. Twenty mild to moderately immunocompromised children and. Flu. Mist or AF- SPG placebo. Frequency and. duration of vaccine virus shedding in these immunocompromised children and. A total of 1. 97 children 8 through 3. Flu. Mist (N = 9. AF- SPG placebo. (N = 9. Virus shedding was evaluated for 2. Wild- type A (A/H3. N2) influenza virus was documented to have. Type A (A/H1. N1) and Type B strains did not. At least one vaccine strain was isolated from 8. Flu. Mist recipients; strains were recovered from 1- 2. The cold- adapted (ca) and. Ten influenza isolates (9 influenza. A, 1 influenza B) were cultured from a total of seven placebo subjects. One. placebo subject had mild symptomatic Type B virus infection confirmed as a. Flu. Mist recipient in the same playgroup. This. Type B isolate retained the ca, ts, and att phenotypes of the vaccine strain. Type B virus cultured from. Four of the influenza Type A. A/Panama (H3. N2). The remaining isolates. Assuming a single transmission event (isolation of the. Type B vaccine strain), the probability of a young child acquiring vaccine. Flu. Mist vaccinee in this daycare. CI: 0, 1. 7) based on the Reed- Frost model. With documented. transmission of one Type B in one placebo subject and possible transmission of. Type A viruses in four placebo subjects, the probability of acquiring a. CI: 0. 1. 3, 4. 6) using. Reed- Frost model. Pharmacokinetics. Biodistribution. A biodistribution study of intranasally administered. The mean. percentages of the delivered doses detected were as follows: nasal cavity. The clinical significance of. Clinical Studies. The effectiveness of Flu. Mist Quadrivalent is based on. Flu. Mist in children and the. Flu. Mist in adults, and a comparison of post vaccination. GMTs) of hemagglutination inhibition (HI) antibodies. Flu. Mist and Flu. Mist Quadrivalent. The clinical. experience with Flu. Mist is relevant to Flu. Mist Quadrivalent because both. A. total number of 3. Flu. Mist and 3. 93. Children who. previously received any influenza vaccine received a single dose of study. As the primary endpoint, culture- confirmed modified. CDC- ILI (CDC- defined influenza- like illness) was defined as a positive culture. See Table 6. for a description of the results by strain and antigenic similarity. Table 6: Comparative Efficacy Against. Culture- Confirmed Modified CDC- ILIa Caused by Wild- Type Strains. Study MI- CP1. 11)b,c Flu. Mist. Active Controld% Reduction in. Rate for Flu. Miste 9. CI N# of Cases. Rate (cases/N)N# of Cases. Rate (cases/N)Matched Strains. All strains. 39. A/H1. N1. 39. 16. A/H3. N2. 39. 16. B3. 91. 65. 01. 3%3. Mismatched Strains. All strains. 39. A/H1. N1. 39. 16. A/H3. N2. 39. 16. B3. 91. 66. 61. 7%3. Regardless of Match. All strains. 39. A/H1. N1. 39. 16. A/H3. N2. 39. 16. B3. 91. 61. 15. 2. ATP Population. a Modified CDC- ILI. This study was performed in Asia over two. The primary endpoint of the trial. Respiratory illness that prompted an influenza. A total of 3. 17. Year 1. See Table 7 for a description of the results. During the second year of Study D1. P5. 01, for children who. Year 1 and one dose in Year 2, Flu. Mist demonstrated 8. CI: 7. 0. 1, 9. 2. Study AV0. 06 was a second multi- center, randomized. AF- SPG placebo- controlled trial performed in U. S. The primary endpoint of the trial was the prevention of. Respiratory illness that prompted. During the. first year of the study, 1. See Table 7 for a description of the. Table 7: Efficacya of Flu. Mist vs. Placebo. Against Culture- Confirmed Influenza Illness Due to Antigenically Matched Wild- Type. Strains (Studies D1. P5. 01b & AV0. Year 1) D1. 53- P5. AV0. 06e. Flu. Mist nf (%)Placebo nf (%)% Efficacy (9. CI)Flu. Mist nf (%)Placebo nf (%)% Efficacy (9. CI)Ng = 1. 65. 3Ng = 1. Ng = 8. 49. Ng = 4. Any strain. 56 (3. A/H1. N1. 23 (1. 4%)8. A/H3. N2. 4 (0. 2%)2. B2. 9 (1. 8%)3. 5 (3. D1. 53- P5. 01 and AV0. In children 1. 2 through 3. In children 1. 5 through 7. NCT0. 01. 92. 24. NCT0. 01. 92. 17. Number and percent of subjects in per- protocol efficacy analysis. Number of subjects in per- protocol efficacy analysis population of. For D1. 53- P5. 01, influenza circulated through 1. Estimate includes A/H1. N1 and A/H1. N2 strains. Both were considered. During the second year of Study AV0. Year 1and received a single dose of Flu. Mist. or placebo. During the second year, the primary circulating strain was the. A/Sydney/0. 5/9. 7 H3. N2 strain, which was antigenically dissimilar from the H3. N2. strain represented in the vaccine, A/Wuhan/3. Flu. Mist demonstrated 8. CI: 7. 7. 0, 9. 2. Immune Response Study Of Flu. Mist Quadrivalent In Children. And Adolescents. A multicenter, randomized, double- blind. MI- CP2. 08) was performed to assess the. Flu. Mist Quadrivalent compared to Flu. Mist (active control) in. A total of 2. 31. Flu. Mist Quadrivalent. Flu. Mist, each containing a B. B strains in Flu. Mist Quadrivalent (a. B strain of the Yamagata lineage or a B strain of the Victoria lineage). Children 2 through 8 years of age received 2 doses of. For children 2 through 8 years of age with a history of influenza. For children 2 through 8 years of age without. For children 9 years of. Immunogenicity was evaluated by comparing the 4. HAI) antibody geometric mean. GMTs) post dosing and provided evidence that the addition of the second. B strain did not result in immune interference to other strains included in the. Effectiveness Study Of Flu. Mist In Adults. AV0. U. S. Participants were randomized 2: 1 (vaccine. Cultures for influenza virus were not obtained from subjects in the. The. A/Wuhan/3. 59/9. H3. N2) strain, which was contained in Flu. Mist, was antigenically. A/Sydney/0. 5/9. 7 (H3. N2). Type A/Wuhan (H3. N2) and Type B strains. U. S. The primary endpoint of. Effectiveness for. Primary and secondary effectiveness endpoints from the. Table 8. Effectiveness was not. Table 8: Effectiveness of Flu. Mist to Prevent Febrile. Illness in Adults 1. Years of Age During the 7- Week Site- Specific. Outbreak Period (Study AV0. Endpoint. Flu. Mist N = 2. Placebo. N = 1. 22. Percent Reduction(9. CI)Participants with one or more events of: b. Primary Endpoint: Any febrile illness. Secondary Endpoints: Severe febrile illness. Febrile upper respiratory illness. Number of evaluable subjects (9. Flu. Mist and placebo recipients, respectively). 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