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A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults.

Abstract

BACKGROUND

Trivalent seasonal influenza vaccines contain 2 A strains and 1 B strain. B strains of 2 antigenically distinct lineages, Yamagata and Victoria, have been co-circulating annually, and the B strain included in vaccines often has not been a lineage match to the major circulating strain. Thus, a vaccine containing B strains from both lineages could broaden protection against influenza. Quadrivalent live attenuated influenza vaccine (Q/LAIV) is an investigational 4-strain formulation of LAIV that contains 2 A strains, A/H1N1 and A/H3N2, and 2 B strains, 1 from each lineage.

METHODS

A randomized, double-blind, active-controlled study of Q/LAIV was conducted in 1800 adults aged 18-49 years to compare the immunogenicity and safety of Q/LAIV to trivalent LAIV (T/LAIV). Subjects were randomized 4:1:1 to receive an intranasal dose of Q/LAIV (n=1200) or 1 of 2 matching T/LAIV vaccines, each containing 1 of the B strains included in Q/LAIV (n=600 total). The primary endpoint was the comparison of the post-vaccination strain-specific geometric mean titers (GMT) of hemagglutination inhibition antibody in Q/LAIV recipients to those in T/LAIV recipients, with immunologic noninferiority of Q/LAIV to be demonstrated if the upper bound of the 2-sided 95% confidence interval (CI) for the ratio of the GMTs [T/LAIV divided by Q/LAIV] was ≤1.5 for all strains.

RESULTS AND CONCLUSION

Q/LAIV met the criteria for noninferiority: the ratios of the GMTs for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria strains were 1.09 (95% CI, 1.01-1.18), 1.05 (95% CI, 0.96-1.14), 1.10 (95% CI, 0.97-1.25), and 0.92 (95% CI, 0.82-1.03), respectively. Solicited symptoms and adverse events were similar in the Q/LAIV and T/LAIV arms. Q/LAIV may confer increased protection against influenza by targeting B strains from both lineages.

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  • Authors+Show Affiliations

    ,

    Kentucky Pediatric and Adult Research, 201 South 5th Street, Bardstown, KY 40004-1142, USA. slblock@pol.net

    , , ,

    Source

    Vaccine 29:50 2011 Nov 21 pg 9391-7

    MeSH

    Administration, Intranasal
    Adolescent
    Adult
    Antibodies, Viral
    Antibody Formation
    Double-Blind Method
    Endpoint Determination
    Hemagglutination Inhibition Tests
    Humans
    Influenza A Virus, H1N1 Subtype
    Influenza A Virus, H3N2 Subtype
    Influenza B virus
    Influenza Vaccines
    Influenza, Human
    Middle Aged
    Vaccines, Attenuated
    Young Adult

    Pub Type(s)

    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    21983154

    Citation

    Block, Stan L., et al. "A Randomized, Double-blind Noninferiority Study of Quadrivalent Live Attenuated Influenza Vaccine in Adults." Vaccine, vol. 29, no. 50, 2011, pp. 9391-7.
    Block SL, Yi T, Sheldon E, et al. A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults. Vaccine. 2011;29(50):9391-7.
    Block, S. L., Yi, T., Sheldon, E., Dubovsky, F., & Falloon, J. (2011). A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults. Vaccine, 29(50), pp. 9391-7. doi:10.1016/j.vaccine.2011.09.109.
    Block SL, et al. A Randomized, Double-blind Noninferiority Study of Quadrivalent Live Attenuated Influenza Vaccine in Adults. Vaccine. 2011 Nov 21;29(50):9391-7. PubMed PMID: 21983154.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults. AU - Block,Stan L, AU - Yi,Tingting, AU - Sheldon,Eric, AU - Dubovsky,Filip, AU - Falloon,Judith, Y1 - 2011/10/06/ PY - 2011/07/18/received PY - 2011/09/13/revised PY - 2011/09/23/accepted PY - 2011/10/11/entrez PY - 2011/10/11/pubmed PY - 2012/4/11/medline SP - 9391 EP - 7 JF - Vaccine JO - Vaccine VL - 29 IS - 50 N2 - BACKGROUND: Trivalent seasonal influenza vaccines contain 2 A strains and 1 B strain. B strains of 2 antigenically distinct lineages, Yamagata and Victoria, have been co-circulating annually, and the B strain included in vaccines often has not been a lineage match to the major circulating strain. Thus, a vaccine containing B strains from both lineages could broaden protection against influenza. Quadrivalent live attenuated influenza vaccine (Q/LAIV) is an investigational 4-strain formulation of LAIV that contains 2 A strains, A/H1N1 and A/H3N2, and 2 B strains, 1 from each lineage. METHODS: A randomized, double-blind, active-controlled study of Q/LAIV was conducted in 1800 adults aged 18-49 years to compare the immunogenicity and safety of Q/LAIV to trivalent LAIV (T/LAIV). Subjects were randomized 4:1:1 to receive an intranasal dose of Q/LAIV (n=1200) or 1 of 2 matching T/LAIV vaccines, each containing 1 of the B strains included in Q/LAIV (n=600 total). The primary endpoint was the comparison of the post-vaccination strain-specific geometric mean titers (GMT) of hemagglutination inhibition antibody in Q/LAIV recipients to those in T/LAIV recipients, with immunologic noninferiority of Q/LAIV to be demonstrated if the upper bound of the 2-sided 95% confidence interval (CI) for the ratio of the GMTs [T/LAIV divided by Q/LAIV] was ≤1.5 for all strains. RESULTS AND CONCLUSION: Q/LAIV met the criteria for noninferiority: the ratios of the GMTs for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria strains were 1.09 (95% CI, 1.01-1.18), 1.05 (95% CI, 0.96-1.14), 1.10 (95% CI, 0.97-1.25), and 0.92 (95% CI, 0.82-1.03), respectively. Solicited symptoms and adverse events were similar in the Q/LAIV and T/LAIV arms. Q/LAIV may confer increased protection against influenza by targeting B strains from both lineages. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/21983154/A_randomized_double_blind_noninferiority_study_of_quadrivalent_live_attenuated_influenza_vaccine_in_adults_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(11)01551-9 DB - PRIME DP - Unbound Medicine ER -