BACKGROUND: Influenza B viruses from 2 lineages cocirculate annually. Because the single B strain contained in trivalent vaccines may not match the major circulating strain, adding a second B virus could enhance protection. This study compared the safety and immunogenicity of an investigational quadrivalent Ann Arbor strain live attenuated influenza vaccine (Q/LAIV) with that of 2 trivalent vaccines (T/LAIV), each containing a B strain from a different lineage. METHODS: This randomized, double-blind study was designed to demonstrate the immunologic noninferiority of Q/LAIV compared with T/LAIV in children 2-17 years of age by comparing postdose geometric mean titers of hemagglutination inhibition antibodies. Children were randomized 3:1:1 to receive Q/LAIV or 1 of 2 T/LAIV vaccines. Those subjects who were 9-17 years of age received 1 dose, and those 2-8 years of age received 2 doses 1 month apart. Serum immune responses were evaluated 1 month after dose 1 (dose 2 for influenza vaccine-naive subjects aged 2-8 years). RESULTS: Q/LAIV was noninferior to T/LAIV: upper bounds for all four 95% confidence intervals for the postdose geometric mean titer ratios (T/LAIV divided by Q/LAIV) were ≤1.5, the predefined noninferiority margin. The overall seroresponse rates (4-fold rise) were comparable between treatment groups. Safety events were comparable, except that fever was more common after dose 1 in Q/LAIV subjects (5.1%) than in T/LAIV subjects (3.1%) 2-8 years of age. CONCLUSIONS: The immunogenicity of Q/LAIV was noninferior to that of T/LAIV in children aged 2-17 years; safety was also comparable. Q/LAIV may broaden the protection against influenza B strains provided by current trivalent influenza vaccines.
RCT Entities:
BACKGROUND: Influenza B viruses from 2 lineages cocirculate annually. Because the single B strain contained in trivalent vaccines may not match the major circulating strain, adding a second B virus could enhance protection. This study compared the safety and immunogenicity of an investigational quadrivalent Ann Arbor strain live attenuated influenza vaccine (Q/LAIV) with that of 2 trivalent vaccines (T/LAIV), each containing a B strain from a different lineage. METHODS: This randomized, double-blind study was designed to demonstrate the immunologic noninferiority of Q/LAIV compared with T/LAIV in children 2-17 years of age by comparing postdose geometric mean titers of hemagglutination inhibition antibodies. Children were randomized 3:1:1 to receive Q/LAIV or 1 of 2 T/LAIV vaccines. Those subjects who were 9-17 years of age received 1 dose, and those 2-8 years of age received 2 doses 1 month apart. Serum immune responses were evaluated 1 month after dose 1 (dose 2 for influenza vaccine-naive subjects aged 2-8 years). RESULTS:Q/LAIV was noninferior to T/LAIV: upper bounds for all four 95% confidence intervals for the postdose geometric mean titer ratios (T/LAIV divided by Q/LAIV) were ≤1.5, the predefined noninferiority margin. The overall seroresponse rates (4-fold rise) were comparable between treatment groups. Safety events were comparable, except that fever was more common after dose 1 in Q/LAIV subjects (5.1%) than in T/LAIV subjects (3.1%) 2-8 years of age. CONCLUSIONS: The immunogenicity of Q/LAIV was noninferior to that of T/LAIV in children aged 2-17 years; safety was also comparable. Q/LAIV may broaden the protection against influenza B strains provided by current trivalent influenza vaccines.
Authors: Annika M Hofstetter; Karthik Natarajan; Daniel Rabinowitz; Raquel Andres Martinez; David Vawdrey; Stephen Arpadi; Melissa S Stockwell Journal: Am J Public Health Date: 2013-05-16 Impact factor: 9.308
Authors: Sara Boccalini; Elena Pariani; Giovanna Elisa Calabrò; Chiara DE Waure; Donatella Panatto; Daniela Amicizia; Piero Luigi Lai; Caterina Rizzo; Emanuele Amodio; Francesco Vitale; Alessandra Casuccio; Maria Luisa DI Pietro; Cristina Galli; Laura Bubba; Laura Pellegrinelli; Leonardo Villani; Floriana D'Ambrosio; Marta Caminiti; Elisa Lorenzini; Paola Fioretti; Rosanna Tindara Micale; Davide Frumento; Elisa Cantova; Flavio Parente; Giacomo Trento; Sara Sottile; Andrea Pugliese; Massimiliano Alberto Biamonte; Duccio Giorgetti; Marco Menicacci; Antonio D'Anna; Claudia Ammoscato; Emanuele LA Gatta; Angela Bechini; Paolo Bonanni Journal: J Prev Med Hyg Date: 2021-09-10
Authors: Manjusha Gaglani; Jessica Pruszynski; Kempapura Murthy; Lydia Clipper; Anne Robertson; Michael Reis; Jessie R Chung; Pedro A Piedra; Vasanthi Avadhanula; Mary Patricia Nowalk; Richard K Zimmerman; Michael L Jackson; Lisa A Jackson; Joshua G Petrie; Suzanne E Ohmit; Arnold S Monto; Huong Q McLean; Edward A Belongia; Alicia M Fry; Brendan Flannery Journal: J Infect Dis Date: 2016-01-06 Impact factor: 7.759