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Vaccine. 2014 Jan 28. pii: S0264-410X(14)00054-1. doi: 10.1016/j.vaccine.2014.01.022. [Epub ahead of print]
Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged ≥18 years: A phase III, randomized trial.
Tinoco JC1, Pavia-Ruz N2, Cruz-Valdez A3, Doniz CA4, Chandrasekaran V5, Dew? W6, Liu A5, Innis BL5, Jain VK5.
Author information
Abstract
BACKGROUND:
Two influenza B lineages have been co-circulating since the 1980s, and because inactivated trivalent influenza vaccine (TIV) contains only one B strain, it provides little/no protection against the alternate B-lineage. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in healthy adults.
METHODS:
Subjects received one dose of QIV (lot 1, 2, or 3) or one of two TIVs (B strain from Victoria or Yamagata lineage); randomization was 2:2:2:1:1. Hemagglutination-inhibition assays were performed 21-days post-vaccination; superiority of QIV versus TIV for the alternate B-lineage was demonstrated if the 95% confidence interval (CI) lower limit for the GMT ratio was ≥1.5, and non-inferiority against the shared strains was demonstrated if the 95% CI upper limit for the GMT ratio was ≤1.5. Reactogenicity and safety were assessed during the post-vaccination period. NCT01196975.
RESULTS:
Immunogenicity of QIV lots was consistent, QIV was superior to TIV for the alternate B-lineage strain, and QIV was non-inferior versus TIVs for shared strains (A/H1N1, A/H3N2, B-strain). Reactogenicity and safety profile of the QIV was consistent with seasonal influenza vaccines.
CONCLUSION:
QIV provided superior immunogenicity for the added B strain without affecting the antibody response to the TIV strains, and without compromising safety.
Copyright ? 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.
KEYWORDS:
AEs, ATP, According to protocol, CBER, CDC, CI, Center for Biologics Evaluation and Research, Center for Disease Control and Prevention, GMT, Geometric mean titer, HA, HI, Hemagglutination inhibition, Hemagglutinin, Inactivated quadrivalent influenza vaccine, MAEs, QIV, SAEs, SCF, SCR, SPR, Seasonal influenza, Serious adverse events, Seroconversion rate, Seroprotection rate, TIV, TIV-B Victoria, TIV-B Yamagata, TIV-Vic, TIV-Yam, Victoria lineage, WHO, World Health Organization, Yamagata lineage, adverse events, confidence interval, inactivated quadrivalent influenza vaccine, inactivated trivalent influenza vaccine, medically attended events, seroconversion factor
PMID:
24486352
[PubMed - as supplied by publisher]
Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged ≥18 years: A phase III, randomized trial.
Tinoco JC1, Pavia-Ruz N2, Cruz-Valdez A3, Doniz CA4, Chandrasekaran V5, Dew? W6, Liu A5, Innis BL5, Jain VK5.
Author information
Abstract
BACKGROUND:
Two influenza B lineages have been co-circulating since the 1980s, and because inactivated trivalent influenza vaccine (TIV) contains only one B strain, it provides little/no protection against the alternate B-lineage. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in healthy adults.
METHODS:
Subjects received one dose of QIV (lot 1, 2, or 3) or one of two TIVs (B strain from Victoria or Yamagata lineage); randomization was 2:2:2:1:1. Hemagglutination-inhibition assays were performed 21-days post-vaccination; superiority of QIV versus TIV for the alternate B-lineage was demonstrated if the 95% confidence interval (CI) lower limit for the GMT ratio was ≥1.5, and non-inferiority against the shared strains was demonstrated if the 95% CI upper limit for the GMT ratio was ≤1.5. Reactogenicity and safety were assessed during the post-vaccination period. NCT01196975.
RESULTS:
Immunogenicity of QIV lots was consistent, QIV was superior to TIV for the alternate B-lineage strain, and QIV was non-inferior versus TIVs for shared strains (A/H1N1, A/H3N2, B-strain). Reactogenicity and safety profile of the QIV was consistent with seasonal influenza vaccines.
CONCLUSION:
QIV provided superior immunogenicity for the added B strain without affecting the antibody response to the TIV strains, and without compromising safety.
Copyright ? 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.
KEYWORDS:
AEs, ATP, According to protocol, CBER, CDC, CI, Center for Biologics Evaluation and Research, Center for Disease Control and Prevention, GMT, Geometric mean titer, HA, HI, Hemagglutination inhibition, Hemagglutinin, Inactivated quadrivalent influenza vaccine, MAEs, QIV, SAEs, SCF, SCR, SPR, Seasonal influenza, Serious adverse events, Seroconversion rate, Seroprotection rate, TIV, TIV-B Victoria, TIV-B Yamagata, TIV-Vic, TIV-Yam, Victoria lineage, WHO, World Health Organization, Yamagata lineage, adverse events, confidence interval, inactivated quadrivalent influenza vaccine, inactivated trivalent influenza vaccine, medically attended events, seroconversion factor
PMID:
24486352
[PubMed - as supplied by publisher]
