Safety and immunogenicity of a quadrivalent inactivated influenza vaccine compared to licensed trivalent inactivated influenza vaccines in adults.
作者： David P. Greenberg , Corwin A. Robertson , Michael J. Noss , Mark M. Blatter , Rex Biedenbender
DOI: 10.1016/J.VACCINE.2012.11.074
关键词: Quadrivalent Inactivated Influenza Vaccine 、 Seroconversion 、 Virology 、 Immunogenicity 、 Immunology 、 Antibody titer 、 Titer 、 Hemagglutination assay 、 Influenza vaccine 、 Vaccination 、 Medicine
摘要: Abstract Purpose To evaluate the safety and immunogenicity of a prototype quadrivalent inactivated influenza vaccine (QIV) containing two B strains, one each lineage, compared with licensed trivalent vaccines (TIVs) either Victoria B-lineage strain (2009–2010 TIV) or Yamagata (2008–2009 TIV). Methods Healthy adults ≥18 years age were eligible to participate in this phase II, open-label, randomized, controlled, multicenter study conducted US. Participants received single dose 2009–2010 TIV, 2008–2009 QIV. Sera collected before 21 days after administration test for hemagglutination inhibition (HAI) antibodies four strains. Immunogenicity endpoints included geometric mean HAI antibody titers (GMTs) rates seroprotection (titer ≥1:40) seroconversion (4-fold rise pre- post-vaccination). Safety frequency solicited injection-site systemic reactions occurring within 3 vaccination, unsolicited non-serious adverse events (AEs) serious AEs (SAEs) vaccination. Results One hundred ninety participants enrolled group. QIV induced GMTs A that noninferior those by TIVs (i.e., lower limit two-sided 95% confidence interval ratio GMT /GMT TIV > 0.66 strain). Rates similar all groups. Incidence severity reactions, AEs, SAEs among Conclusion QIV, strains (one from lineage), was as safe immunogenic TIV. has potential be useful alternative offer protection against both lineages.
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