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| DOI | 10.3390/VACCINES12080892 | ||||
| Año | 2024 | ||||
| Tipo | artículo de investigación |
Citas Totales
Autores Afiliación Chile
Instituciones Chile
% Participación
Internacional
Autores
Afiliación Extranjera
Instituciones
Extranjeras
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.
| 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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| Agradecimiento |
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| 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. |