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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
Indexado
WoS WOS:001307489700001
Scopus SCOPUS_ID:85202536420
DOI 10.3390/VACCINES12080892
Año 2024
Tipo artículo de investigación

Citas Totales

Autores Afiliación Chile

Instituciones Chile

% Participación
Internacional

Autores
Afiliación Extranjera

Instituciones
Extranjeras


Abstract



Objectives: 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.

Revista



Revista ISSN
Vaccines 2076-393X

Métricas Externas



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Disciplinas de Investigación



WOS
Immunology
Medicine, Research & Experimental
Scopus
Sin Disciplinas
SciELO
Sin Disciplinas

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Publicaciones WoS (Ediciones: ISSHP, ISTP, AHCI, SSCI, SCI), Scopus, SciELO Chile.

Colaboración Institucional



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Autores - Afiliación



Ord. Autor Género Institución - País
1 Yang, Wanqi - Sinovac Biotech Co Ltd - China
Sinovac Biotech Ltd. - China
2 GONZALEZ-SANCHEZ, PATRICIA Hombre Instituto Milenio de Oceanografía - Chile
Pontificia Universidad Católica de Chile - Chile
Instituto Milenio de Inmunología e Inmunoterapia - Chile
3 Xin, Qianqian - Sinovac Life Sci Co Ltd - China
Sinovac Biotech Co Ltd - China
Sinovac Biotech Ltd. - China
4 Reyes, Mari Rose De Los - Las Pinas Doctors Hospital - Filipinas
4 De Los Reyes, Mari Rose - Las Pinas Doctors Hosp - Filipinas
5 Villalobos, Ralph Elvi - Philippines Gen Hosp - Filipinas
Philippine General Hospital - Filipinas
6 Borja-Tabora, Charissa Fay Corazon - Trop Dis Fdn Inc - Filipinas
7 Bermal, Nancy Nazaire - San Juan De Dios Hosp - Filipinas
San Juan de Dios Hospital - Filipinas
8 KALERGIS-PARRA, ALEXIS MIKES Hombre Instituto Milenio de Oceanografía - Chile
Pontificia Universidad Católica de Chile - Chile
Instituto Milenio de Inmunología e Inmunoterapia - Chile
Facultad de Medicina - Chile
9 Yu, Dan - Sinovac Biotech Co Ltd - China
Sinovac Biotech Ltd. - China
10 Wu, Wenbin - Sinovac Life Sci Co Ltd - China
Sinovac Biotech Co Ltd - China
Sinovac Biotech Ltd. - China
11 BUENO-RAMIREZ, SUSAN MARCELA Mujer Instituto Milenio de Oceanografía - Chile
Pontificia Universidad Católica de Chile - Chile
Instituto Milenio de Inmunología e Inmunoterapia - Chile
12 Huo, Liqun - Sinovac Biotech Co Ltd - China
Sinovac Biotech Ltd. - China
13 CALVO-GIL, MARIO ALFONSO Hombre Instituto Milenio de Oceanografía - Chile
Universidad Austral de Chile - Chile
Instituto Milenio de Inmunología e Inmunoterapia - Chile
14 Zeng, Gang - Sinovac Biotech Co Ltd - China
Sinovac Biotech Ltd. - China
15 Li, Jing - Sinovac Biotech Co Ltd - China
Sinovac Biotech Ltd. - China
16 QINF Study Grp Corporación Sinovac Biotech Co Ltd - China

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Financiamiento



Fuente
Sinovac Biotech Co., Ltd
Sinovac Biotech Co., Ltd.

Muestra la fuente de financiamiento declarada en la publicación.

Agradecimientos



Agradecimiento
The study was funded by sponsor, Sinovac Biotech Co., Ltd. The sponsor provided funding for study design, data collection, antibody detection and statistical analysis.
The study was funded by sponsor, Sinovac Biotech Co., Ltd. The sponsor provided funding for study design, data collection, antibody detection and statistical analysis.

Muestra la fuente de financiamiento declarada en la publicación.