Delving into the Latest Updates on Influenza Vaccine (Split Virion), Inactivated, Quadrivalent(Sinovac Biotech Ltd.) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine, Multivalent vaccine

Synonyms

迪福赛尔

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Influenza, Human

Inactive Indication-

Originator Organization

Sinovac Biotech Co. Ltd.

Active Organization

Sinovac Biotech Co. Ltd.

Inactive Organization

Pontificia Universidad Católica de Chile

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (17 Jun 2020),

Influenza, Human

Regulation-

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This study is a randomized, controlled, open-label phase Ⅳ clinical trial of a live attenuated mumps vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the booster doses of a mumps vaccine administrated alone and concomitantly with a quadrivalent inactivated influenza vaccine in healthy junior high school students. And the cross-neutralization of mumps vaccine immune serum and mumps virus strains

Start Date04 Nov 2023

Sponsor / Collaborator

Sinovac Biotech Co. Ltd.

CTR20232941

/ Active, not recruitingPhase 3

四价流感病毒裂解疫苗在6~35月龄婴幼儿人群中接种的安全性和免疫原性的随机、盲法、阳性对照的Ⅲ期临床试验

[Translation] A randomized, blinded, positive-controlled phase III clinical trial on the safety and immunogenicity of quadrivalent influenza virus split vaccine in infants aged 6 to 35 months

评价北京科兴生物制品有限公司研制的四价流感疫苗接种6~35月龄婴幼儿的免疫原性和安全性。

[Translation]

To evaluate the immunogenicity and safety of the quadrivalent influenza vaccine developed by Beijing Sinovac Biotech Co., Ltd. in infants aged 6 to 35 months.

Start Date16 Sep 2023

Sponsor / Collaborator

Sinovac Biotech Co. Ltd.

NCT06049927

/ CompletedPhase 3

An Randomized, Double-blind, Controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35months

A phase III clinical trial of the study of quadrivalent influenza vaccine developed by Sinovac Biotech will be conducted in Chinese children aged 6 to 35 months. The trial is an randomized, double-blind and active controlled study. The objective of this study is to evaluate the Immunogenicity and safety of the vaccine.

Start Date16 Sep 2023

Sponsor / Collaborator

Sinovac Biotech Co. Ltd.

100 Clinical Results associated with Influenza Vaccine (Split Virion), Inactivated, Quadrivalent(Sinovac Biotech Ltd.)

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100 Translational Medicine associated with Influenza Vaccine (Split Virion), Inactivated, Quadrivalent(Sinovac Biotech Ltd.)

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100 Patents (Medical) associated with Influenza Vaccine (Split Virion), Inactivated, Quadrivalent(Sinovac Biotech Ltd.)

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30

Literatures (Medical) associated with Influenza Vaccine (Split Virion), Inactivated, Quadrivalent(Sinovac Biotech Ltd.)

31 Dec 2024·Human Vaccines & Immunotherapeutics

Immunogenicity and safety of concomitant administration of recombinant COVID-19 vaccine and quadrivalent inactivated influenza vaccine in Chinese adults: An open-label, randomized, controlled trial

Article

Author: Huang, Tao ; Gao, Lidong ; Yu, Jun ; Zhang, Siyuan ; Dai, Defang ; Teng, Dewei ; Zhu, Yinbiao

The immunogenicity and safety of the concomitant administration of recombinant COVID-19 vaccine and quadrivalent inactivated influenza vaccine (Split Virion) (QIIV) in Chinese adults are unclear. In this open-label, randomized controlled trial, participants aged ≥ 18 years were recruited. Eligible healthy adults were randomly assigned (1:1) to receive QIIV at the same time as the first dose of COVID-19 vaccine (simultaneous-group) or 14 days after the second dose of COVID-19 vaccine (non-simultaneous-group). The primary outcome was to compare the difference in immunogenicity of QIIV (H1N1, H3N2, Yamagata, and Victoria) between the two groups. A total of 299 participants were enrolled, 149 in the simultaneous-group and 150 in the non-simultaneous-group. There were no significant differences in geometric mean titer (GMT) [H1N1: 386.4 (95%CI: 299.2-499.0) vs. 497.4 (95%CI: 377.5-655.3); H3N2: 66.9 (95%CI: 56.1-79.8) vs. 81.4 (95%CI: 67.9-97.5); Yamagata: 95.6 (95%CI: 79.0-115.8) vs. 74.3 (95%CI: 58.6-94.0); and Victoria: 48.5 (95%CI: 37.6-62.6) vs. 65.8 (95%CI: 49.0-88.4)] and seroconversion rate (H1N1: 87.5% vs. 90.1%; H3N2: 58.1% vs. 62.0%; Yamagata: 75.0% vs. 64.5%; and Victoria: 55.1% vs. 62.8%) of QIIV antibodies between the simultaneous and non-simultaneous groups. For the seroprotection rate of QIIV antibodies, a higher seroprotection rate of Yamagata antibody was observed only in the simultaneous-group than in the non-simultaneous-group [86.0% vs. 76.0%, p = .040]. In addition, no significant difference in adverse events was observed between the two groups (14.2% vs. 23.5%, p = .053). In conclusion, no immune interference or safety concerns were found for concomitant administration of COVID-19 vaccine with QIIV in adults aged ≥ 18 years.

01 Jan 2024·Journal of Infection and Chemotherapy

Pediatric hemophagocytic lymphohistiocytosis after concomitant administration of SARS-CoV-2 vaccine and influenza vaccine

Author: Gocho, Yoshihiro ; Uchiyama, Toru ; Maekawa, Takanobu ; Kubota, Mitsuru ; Funaki, Takanori ; Ishiguro, Akira ; Hirata, Yuiko ; Yasumi, Takahiro ; Morooka, Shintaro ; Kaizuka, Anna ; Tokuda, Yusuke

Hemophagocytic lymphohistiocytosis (HLH) is a highly lethal disease characterized by fever, cytopenia, splenomegaly, and hemophagocytosis. Whereas infectious diseases, malignant tumors, and autoimmune diseases are often triggers for HLH, reports of HLH associated with vaccination are limited. In this report, we describe a case of HLH in a 12-year-old female patient after simultaneous administration of the bivalent messenger RNA severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine and quadrivalent inactivated influenza vaccine. The patient presented to our hospital with fever on the day after vaccination. Considering the splenomegaly, cytopenia, hemophagocytosis in the bone marrow, and high ferritin level, HLH was diagnosed 12 days after vaccination. Various tests ruled out any infectious disease, malignant tumor, or autoimmune disease. The patient was treated only with 2 mg/kg/day of oral prednisolone, fever improved 13 days after vaccination, and blood test findings rapidly improved. Although HLH after SARS-CoV-2 vaccination or concomitant administration with influenza vaccination is still rare, we emphasize the importance of early HLH diagnosis when persistent fever is observed following vaccination.

01 Aug 2023·Human Vaccines & Immunotherapeutics

Immunogenicity and safety of quadrivalent inactivated influenza vaccine in children aged 6 to 35 months: A systematic review and meta-analysis

Review

Author: Lei, Shiguang ; Zhang, Ruizhi ; Tan, Xue ; Guan, Qinghu ; Wei, Xia ; Wei, Shaofeng

Evidence of the immunogenicity and safety of quadrivalent inactivated influenza vaccine in children aged 6 to 35 months has been emerging. To evaluate the immunogenicity and safety of quadrivalent inactivated influenza vaccine in children aged 6 to 35 months in a systematic review and meta-analysis. This meta-analysis included 12 studies with 6722 participants receiving QIV, 3575 participants receiving TIV, 4249 participants receiving full-dose QIV (F-QIV), and 3722 participants receiving half-dose QIV (H-QIV). Among children aged 6 to 35 months, QIV produces a better Immunogenicity against influenza B vaccine strains not contained in TIV. However, injection site reaction was more common for QIV, F-QIV showed superior efficacy for the B lineage, but fever and injection site pain was more frequently reported for F-QIV than H-QIV. These data support the immunogenicity and safety of quadrivalent inactivated influenza vaccine among children aged 6 to 35 months.

100 Deals associated with Influenza Vaccine (Split Virion), Inactivated, Quadrivalent(Sinovac Biotech Ltd.)

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