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doi:10.1016/j.vaccine.2011.09.109 | How to Cite or Link Using DOI
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A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults☆
Stan L. Blocka, Corresponding Author Contact Information, E-mail The Corresponding Author, Tingting Yib, E-mail The Corresponding Author, Eric Sheldonc, E-mail The Corresponding Author, Filip Dubovskyb, E-mail The Corresponding Author, Judith Falloonb, E-mail The Corresponding Author
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a Kentucky Pediatric and Adult Research, 201 South 5th Street, Bardstown, KY 40004-1142, USA
b MedImmune, LLC, One MedImmune Way, Gaithersburg, MD 20878, USA
c Miami Research Associates, 6141 Sunset Drive Suite 501, Miami, FL 33143, USA
Received 18 July 2011; revised 13 September 2011; Accepted 23 September 2011. Available online 6 October 2011.
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.
Highlights
► Influenza B strains from 2 lineages cocirculate, but vaccines contain 1 B strain. ► Q/LAIV (live attenuated influenza vaccine with 2 B strains) was studied in adults. ► The immunogenicity of Q/LAIV was noninferior to that of trivalent LAIV. ► The safety profile of Q/LAIV was similar to that of T/LAIV.
http://www.sciencedirect.com/science/article/pii/S0264410X11015519
Permissions & Reprints
A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults☆
Stan L. Blocka, Corresponding Author Contact Information, E-mail The Corresponding Author, Tingting Yib, E-mail The Corresponding Author, Eric Sheldonc, E-mail The Corresponding Author, Filip Dubovskyb, E-mail The Corresponding Author, Judith Falloonb, E-mail The Corresponding Author
Purchase
a Kentucky Pediatric and Adult Research, 201 South 5th Street, Bardstown, KY 40004-1142, USA
b MedImmune, LLC, One MedImmune Way, Gaithersburg, MD 20878, USA
c Miami Research Associates, 6141 Sunset Drive Suite 501, Miami, FL 33143, USA
Received 18 July 2011; revised 13 September 2011; Accepted 23 September 2011. Available online 6 October 2011.
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.
Highlights
► Influenza B strains from 2 lineages cocirculate, but vaccines contain 1 B strain. ► Q/LAIV (live attenuated influenza vaccine with 2 B strains) was studied in adults. ► The immunogenicity of Q/LAIV was noninferior to that of trivalent LAIV. ► The safety profile of Q/LAIV was similar to that of T/LAIV.
http://www.sciencedirect.com/science/article/pii/S0264410X11015519