Immunogenicity and safety of quadrivalent versus trivalent inactivated subunit influenza vaccine in children and adolescents: A phase III randomized study
| Autor: | Emanuele Montomoli, Serge van de Witte, Jos Nauta, Giulia Lapini, Timo Vesikari |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Microbiology (medical) Trivalent influenza vaccine Male Adolescent Influenza vaccine 030106 microbiology Hemagglutinin (influenza) Antibodies Viral law.invention 03 medical and health sciences 0302 clinical medicine Immunogenicity Vaccine Randomized controlled trial Double-Blind Method law Influenza Human Medicine Humans 030212 general & internal medicine Child Reactogenicity biology business.industry Immunogenicity General Medicine Virology Influenza B virus Infectious Diseases Tolerability Vaccines Inactivated Influenza Vaccines Child Preschool biology.protein Female business Neuraminidase |
| Zdroj: | International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases. 92 |
| ISSN: | 1878-3511 |
| Popis: | To analyse the immunogenicity and safety of inactivated subunit quadrivalent influenza vaccine (QIV) versus trivalent influenza vaccine (TIV) in children and adolescents 3-17 years of age.In this phase III, multicentre, double-blind study, 1200 subjects were randomized to receive QIV (n=402), TIV with the B-strain of the Victoria lineage (n=404), or TIV with the B-strain of the Yamagata lineage (n=394). The primary objective was to demonstrate non-inferiority of QIV to TIV for immunogenicity against shared influenza strains, based on post-vaccination hemagglutinin inhibition (HI) titres. Secondary objectives were to show superiority of QIV to TIV for immunogenicity against alternate-lineage B-strains, and to further characterize the immune response by analysing virus neutralization and neuraminidase inhibition titres. Reactogenicity and safety were also compared post-vaccination.QIV elicited a non-inferior response for shared strains (upper limits of the 95% confidence intervals for the HI geometric mean ratios (GMRs) of TIV/QIV1.5) and a superior response for alternate-lineage B-strains (HI GMRs of TIV/QIV1.0; p0.0001) versus TIV. Reporting rates of local and systemic adverse reactions were similar between vaccine arms.QIV had comparable immunogenicity to TIV for shared strains and superior immunogenicity to the alternate-lineage B-strains in TIV. Safety and tolerability profiles were comparable. |
| Databáze: | OpenAIRE |
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