A Phase I/II Randomized Double Blind Controlled Study to Evaluate the Safety and Immunogenicity of GPO Seasonal Tetravalent Inactivated Split Virion Influenza Vaccine in Healthy Thais

The study is aim to evaluate the safety and immunogenicity of one dose TetraFluvac TF vaccine (15 μg HA per strain per dose) of the GPO seasonal quadrivalent inactivated split virion influenza vaccine in healthy adults aged 18 years and above over 90 days post-injection.

Start Date04 Nov 2023

Sponsor / Collaborator

Mahidol University

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100 Clinical Results associated with Seasonal quadrivalent inactivated split virion influenza vaccine(GPO)

100 Translational Medicine associated with Seasonal quadrivalent inactivated split virion influenza vaccine(GPO)

100 Patents (Medical) associated with Seasonal quadrivalent inactivated split virion influenza vaccine(GPO)

Literatures (Medical) associated with Seasonal quadrivalent inactivated split virion influenza vaccine(GPO)

01 Aug 2023·Human Vaccines & Immunotherapeutics

Immunogenicity and safety of the quadrivalent inactivated split-virion influenza vaccine in populations aged ≥ 3 years: A phase 3, randomized, double-blind, non-inferiority clinical trial

Article

Author: Li, Xiaoyu ; Li, Lanshu ; Wang, Feiyu ; Chai, Jing ; Zhou, Lei ; Li, Ansheng ; Fu, Liandi ; Wang, Minghui ; Ling, Weijun ; Guan, Qinghu ; Gao, Hongxia ; Chen, Jianmin ; Deng, Haobin ; Zhao, Chenyan ; Nie, Fei ; Jiang, Feng

This study aimed to evaluate the immunogenicity non-inferiority and safety of the quadrivalent inactivated split-virion influenza vaccine in participants ≥ 3 years old. A total of 3,328 participants were enrolled. Participants 3-8 years old were administered one or two doses of the investigational vaccine or one dose of the control vaccine, whereas the other participants were administered only one dose of the investigational or control vaccine. The immunogenicity and occurrence of adverse events (AEs) after 30 days of full-course vaccination and serious adverse events (SAEs) within 6 months after full-course vaccination were assessed. The sero-conversion rates (SCRs) of anti-H1N1, H3N2, B(Y), and B(V) antibodies in the test group were 74.64%, 87.40%, 82.66%, and 78.89%, respectively, and their geometric mean titers were 1:250.13, 1:394.54, 1:200.84, and 1:94.91, respectively, which were non-inferior to those in the control group. The SCRs and sero-protection rates in the two-dose group of participants 3-8 years old were greater than those in the one-dose group. The incidences of total AEs and adverse reactions in the test group were 31.6% and 21.7%, respectively, which were close to those in the control group. In the two-dose group, the incidence of adverse reactions was considerably lower in the second dose (5.5%) than in the first dose (14.7%). Most AEs were grade 1 in severity, and no SAEs were recorded. The investigational vaccine had immunogenicity non-inferior to the control vaccine, and two doses were more effective than one dose in participants 3-8 years old, with a good overall safety.Trial registration: CTR20200715.

01 Aug 2023·Antiviral Research

Development of MDCK-based quadrivalent split seasonal influenza virus vaccine with high safety and immunoprotection: A preclinical study

Article

Author: Zhang, Qingmei ; Zhou, Li ; Liu, Bo ; Ma, Zhongren ; Li, Xuedan ; Li, Fang ; Ma, Yumei ; Nian, Xuanxuan ; Jin, Dongwu ; Li, Xinguo ; Han, Xixin ; Zhang, Jiayou ; Zhang, Zhegang ; Tian, Yichao ; Duan, Kai ; Qiu, Ran ; Yang, Ying ; Yang, Xiaoming ; Zhao, Wei ; Ma, Hua ; Gong, Zheng

Vaccination remains the best prevention strategy against influenza. The MDCK-based influenza vaccine prompted the development of innovative cell culture manufacturing processes. In the present study, we report the effects of multiple administrations of a candidate, seasonal, MDCK-based, quadrivalent split influenza virus vaccine MDCK-QIV in Sprague-Dawley (SD) rats. Moreover, the effects of the vaccine were evaluated in terms of fertility and early embryonic development, embryo-fetal development, and perinatal toxicity in the SD rats and immunogenicity in Wistar rats and BALB/c mice. Regarding the safety profile, MDCK-QIV demonstrated tolerance in local stimulation with repeated dose administration and presented no significant effect on the development, growth, behavior, fertility, and reproductive performance of the adult male rats, maternal rats, and their offspring. MDCK-QIV elicited strong hemagglutination inhibition neutralizing antibody response and protection against the influenza virus in the mouse model. Thus, data supported that MDCK-QIV could be further evaluated in human clinical trial, which is currently underway.

01 Jun 2023·Infectious diseases and therapy

Post-Marketing Safety Surveillance of Quadrivalent Influenza Vaccine (VaxigripTetra) in Children Aged 6 to 35 Months in South Korea.

Article

Author: Syrkina, Olga ; Fournier, Marion ; Shin, Sooyoun ; Choe, Sunho ; Talanova, Oxana

INTRODUCTIONThe quadrivalent inactivated split-virion influenza vaccine (QIV; VaxigripTetra^®) was initially licensed in South Korea in 2017 for immunization against seasonal influenza in those aged ≥ 3 years, with the indicated age subsequently lowered to include those aged ≥ 6 months in 2018. Here, to comply with South Korean licensure requirements, we undertook a post-marketing surveillance study to assess the safety of QIV in children aged 6-35 months (i.e., extension of the previous age indication to include these young children) in routine clinical practice.METHODSA multicenter, observational, active safety surveillance of children aged 6-35 months who received a single dose of QIV during a routine healthcare visit was undertaken in South Korea from 15 June 2018 to 14 June 2022. Solicited adverse events (AEs) and unsolicited non-serious AEs were recorded in diary cards, with serious adverse events (SAEs) notified to study investigators.RESULTSThis safety analysis included 676 participants. No AEs led to study termination, and no SAEs were reported. The most frequent solicited injection site reaction was pain in both the ≤ 23-month (12.2% [55/450]) and ≥ 24-month (15.5% [35/226]) age groups. The most frequent solicited systemic reactions were pyrexia and somnolence in the ≤ 23-month age group (6.0% [27/450] each), and malaise (10.6% [24/226]) in the ≥ 24-month age group. Overall, 208 (30.8%) participants experienced 339 unsolicited non-serious AEs, with nasopharyngitis the most common (14.1% [95/676]), and nearly all events (98.8% [335/339]) were considered unrelated to QIV. Grade 3 solicited reactions and unsolicited non-serious AEs were reported in five (0.7%) and three (0.4%) participants, respectively, all of whom recovered by day 7 after vaccination.CONCLUSIONThis active safety surveillance study confirms that QIV is well tolerated in children aged 6-35 months in routine clinical practice in South Korea. There were no safety concerns observed in these young children.

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