Evidence map›Paper›PMID 39204018›Full record

ArticleVaccines2024

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.

Wanqi Yang, Pablo A González, Qianqian Xin, Mari Rose De Los Reyes, Ralph Elvi Villalobos, Charissa Fay Corazon Borja-Tabora, Nancy Nazaire Bermal, Alexis M Kalergis, Dan Yu, Wenbin Wu and 6 more

Abstract read
In one paragraph

Article in Vaccines, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Wanqi YangSinovac Biotech Co., Ltd., Beijing 100085, China.
Pablo A GonzálezMillennium Institute on Immunology and Immunotherapy, Santiago 7810128, Chile.ORCID 0000-0001-7709-6870
Qianqian XinSinovac Life Sciences Co., Ltd., Beijing 102601, China.
Mari Rose De Los ReyesLas Pinas Doctors Hospital, Metro Manila 1008, Philippines.ORCID 0000-0002-9622-7386
Ralph Elvi VillalobosPhilippines General Hospital, Metro Manila 1000, Philippines.ORCID 0000-0002-6941-9139
Charissa Fay Corazon Borja-TaboraTropical Disease Foundation, Inc., Metro Manila 1230, Philippines.
Nancy Nazaire BermalSan Juan De Dios Hospital, Pasay 1300, Philippines.
Alexis M KalergisMillennium Institute on Immunology and Immunotherapy, Santiago 7810128, Chile.ORCID 0000-0001-7622-5263
Dan YuSinovac Biotech Co., Ltd., Beijing 100085, China.
Wenbin WuSinovac Life Sciences Co., Ltd., Beijing 102601, China.
Susan M BuenoMillennium Institute on Immunology and Immunotherapy, Santiago 7810128, Chile.ORCID 0000-0002-7551-8088
Liqun HuoSinovac Biotech Co., Ltd., Beijing 100085, China.
Mario CalvoMillennium Institute on Immunology and Immunotherapy, Santiago 7810128, Chile.
Qinf Study Group
Gang ZengSinovac Biotech Co., Ltd., Beijing 100085, China.ORCID 0000-0003-0385-8742
Jing LiSinovac Biotech Co., Ltd., Beijing 100085, China.

Funding

NEW MEXICO INTEGRATED CORE VIOLENCE AND INJURY PREVENTION AND CONTROL PROGRAMU17CE002021 · CE · NEW MEXICO STATE DEPARTMENT OF HEALTH · PI GONZALES, FRIEDA · 2011 to 2011
$247k
NCIPC CDC HHS U17 CE002021Sinovac Biotech Co., Ltd Not applicable
6 · The paper itself

Abstract

objectivesIn 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

methodsA 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.

resultsA 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.

conclusionsThe 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.

Indexed as

immunogenicitynon-inferiorityquadrivalent influenza vaccinesafety

Identifiers

PMID39204018
PMCPMC11360333

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.