Immunogenicity and Safety of a Quadrivalent Influenza Vaccine in Population Aged 3 Years and Older in Chile and the Philippines: A Phase 3, Non-Inferiority, Double-Blind, Randomized Controlled Clinical Trial

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dc.contributor.authorYang, Wanqi
dc.contributor.authorGonzalez, Pablo A.
dc.contributor.authorXin, Qianqian
dc.contributor.authorDe Los Reyes, Mari Rose
dc.contributor.authorVillalobos, Ralph Elvi
dc.contributor.authorBorja-Tabora, Charissa Fay Corazon
dc.contributor.authorBermal, Nancy Nazaire
dc.contributor.authorKalergis, Alexis M.
dc.contributor.authorYu, Dan
dc.contributor.authorWu, Wenbin
dc.contributor.authorBueno, Susan M.
dc.contributor.authorHuo, Liqun
dc.contributor.authorCalvo, Mario
dc.contributor.authorZeng, Gang
dc.contributor.authorLi, Jing
dc.date.accessioned2025-01-20T16:09:18Z
dc.date.available2025-01-20T16:09:18Z
dc.date.issued2024
dc.description.abstractObjectives: In this study, we aimed to evaluate the non-inferiority of a quadrivalent influenza vaccine (QIV) developed by Sinovac Biotech Co., Ltd. (Sinovac, Beijing, China) by comparing its immunogenicity and safety with a comparator QIV (Vaxigrip Tetra (R)) in a population aged 3 years and older in Chile and the Philippines. Methods: A phase 3, non-inferiority, double-blind, randomized controlled, multicenter clinical trial was conducted in the southern hemisphere (SH) 2023 influenza season. Participants aged >= 3 years old with stable health were randomized 1:1 to receive either Sinovac QIV or comparator QIV. The co-primary outcomes were immunological non-inferiority for Sinovac QIV versus the comparator against each strain contained in the vaccines in terms of seroconversion rates (SCRs) and geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibodies 28 days after final vaccination. Results: A total of 2039 participants were vaccinated (1019 Sinovac QIV; 1020 comparator QIV). Sinovac QIV induced non-inferior immune responses to all four strains as compared to comparator QIV, with slightly higher GMTs than those of comparator QIV: GMT ratios (lower limit 95% confidence interval (CI)) were 1.8 (1.6) for A(H1N1), 1.4 (1.3) for A (H3N2), 1.3 (1.1) for B Victoria and 1.2 (1.1) for B Yamagata; observed seroconversion rate differences (lower limit 95% CI) were 9.6% (6.7) for A(H1N1), 7.0% (3.5) for A(H3N2), 2.4% (-0.03) for B Victoria and 6.8% (3.0) for B Yamagata. Adverse reactions were similar across the two groups and no vaccine-related serious adverse events were reported. Conclusions: The immunogenicity of Sinovac QIV was non-inferior to that of the comparator QIV in these populations aged 3 years and older, and safety was comparable.
dc.fuente.origenWOS
dc.identifier.doi10.3390/vaccines12080892
dc.identifier.eissn2076-393X
dc.identifier.urihttps://doi.org/10.3390/vaccines12080892
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/90145
dc.identifier.wosidWOS:001307489700001
dc.issue.numero8
dc.language.isoen
dc.revistaVaccines
dc.rightsacceso restringido
dc.subjectquadrivalent influenza vaccine
dc.subjectnon-inferiority
dc.subjectimmunogenicity
dc.subjectsafety
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titleImmunogenicity and Safety of a Quadrivalent Influenza Vaccine in Population Aged 3 Years and Older in Chile and the Philippines: A Phase 3, Non-Inferiority, Double-Blind, Randomized Controlled Clinical Trial
dc.typeartículo
dc.volumen12
sipa.indexWOS
sipa.trazabilidadWOS;2025-01-12
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