Safety of a quadrivalent influenza vaccine in Vietnamese healthy subjects aged 6 months and older

Thiểm, Vũ Đình; Chabanon, Anne-Laure; Fournier, Marion; Lavis, Nathalie; Quang, Nguyen Dang; Ha, Vu Hai; Sanicas, Melvin

doi:10.1080/21645515.2020.1795477

Cited by 6 publications

(4 citation statements)

References 10 publications

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“…The most frequently reported solicited reactions were injection site pain, myalgia, and malaise. Overall, the QIV safety profile observed in our study appears generally similar or no worse than that reported from a clinical trial undertaken with QIV in adults in South Korea and other clinical trials conducted elsewhere, including countries in Asia across a range of age groups (though one small study did report much lower rates of myalgia and malaise [20]) [18,[20][21][22]. The frequency of AEs in our study appears generally higher than those reported in passive surveillance studies conducted in Europe [23][24][25], due likely in part to the prospective soliciting of these events using diary cards in a manner similar to clinical trials in our study.…”

Section: Discussionsupporting

confidence: 81%

Post-marketing Surveillance of a Quadrivalent Influenza Vaccine (Vaxigrip Tetra) in South Korea

Lim

Li²,

Syrkina

et al. 2022

Infect Dis Ther

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Introduction In 2017, a quadrivalent inactivated split-virion influenza vaccine (QIV; Vaxigrip Tetra ® , Sanofi) was licensed in South Korea for active immunization against influenza A and influenza B viruses in individuals aged 3 years or older, which was subsequently extended to individuals aged 6 months or older in 2018. Post-marketing surveillance trials are mandatory in South Korea to retain drug licensure. Here, we assessed the safety of QIV in routine clinical practice in South Korea. Methods This was an open, multicenter, observational, active safety surveillance study conducted between 20 June 2017 and 19 June 2021 at 10 study sites in South Korea in individuals aged 3 years or older who received a single dose of QIV during a routine healthcare visit. The participants or their legally acceptable representatives were instructed to record any adverse reactions (solicited events) and unsolicited non-serious adverse events (AE) in diary cards, and notify study investigators in case of serious adverse events (SAE). Results Overall, 663 participants were included in this study. There were no AEs leading to study termination, and no SAEs reported. Injection site pain (278 [41.9%]) was the most frequent solicited injection site reaction, with myalgia (250 [37.7%]) and malaise (236 [35.6%]) the most frequent solicited systemic reactions. Grade 3 solicited injection site and systemic reactions were reported by 8 (1.2%) and 13 (2.0%) participants, respectively; most participants with solicited reactions recovered without the need for further action. Overall, 39 (5.9%) participants experienced 49 unsolicited non-serious AEs with the most frequently reported being nasopharyngitis (19 [2.9%]). Grade 3 unsolicited non-serious adverse events were reported in 1 (0.2%) participant. None of the unsolicited non-serious AEs were considered to be related to QIV. Conclusion This post-marketing surveillance study confirms that QIV is well tolerated and has an acceptable safety profile in routine practice in South Korea. No unexpected safety concerns were identified. Trial Registration ClinicalTrials.gov identifier NCT05406180.

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Section: Discussionsupporting

confidence: 81%

Post-marketing Surveillance of a Quadrivalent Influenza Vaccine (Vaxigrip Tetra) in South Korea

Lim

Li²,

Syrkina

et al. 2022

Infect Dis Ther

Self Cite

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“…Safety is an important indicator of vaccine production. Thime et al found that no serious unsolicited adverse events or vaccine-related SAEs were reported in the Phase III clinical trial [ 15 ]. When the vaccine was administered to children, the most common reaction was pain and tenderness at the injection site, but this subsided within 3 days, and there was only one unsolicited adverse reaction associated with the vaccine, but these were Grade 2 or 4 transient [ 9 ].…”

Section: Discussionmentioning

confidence: 99%

“…( 14) An axillary temperature of ≥37.5 • C before administering the vaccine. (15) The researchers deem that some other factor compromises eligibility for this clinical trial.…”

Section: Study Populationmentioning

confidence: 99%

Exploratory Study of the Phase IV Immunization Schedule of Quadrivalent Influenza Split-Virion Vaccine in Children Aged 3–8 Years

Li,

Kou,

Liu

et al. 2024

Vaccines

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This study explored the optimum immunization schedule for the quadrivalent influenza split-virion vaccine containing influenza A strains (H1N1 and H3N2) and B lineage strains (Yamagata and Victoria) in children aged 3–8 years. The 652 participants enrolled were divided into two groups based on a history of influenza immunization (IH group) or no history of influenza immunization (NH group). The groups were administered a two-dose immunization schedule on days 0 and 30. In the NH group, on day 30 after the first dose, the positive rates of influenza hemagglutination-inhibition antibodies of strains H1N1, H3N2, BV, and BY were 85.85%, 71.70%, 65.27% and 60.45%, respectively. The positive rates of BV and BY failed to meet the absolute criteria for evaluating the immunogenicity of influenza vaccine in the population aged 3–60 years (for each strain antibody). On day 30 after the second dose, HI antibodies to strains H1N1, H3N2, BV, and BY met the immunogenicity acceptable criteria. In the IH group, on day 30 after the first dose, HI antibodies to strains H1N1, H3N2, BV, and BY met the acceptable criteria for immunogenicity. The incidence rates of adverse reactions (vaccine-related adverse events) from the first dose up until 30 days after the second dose were 20.80% in the IH group and 19.50% in the NH group. Only two Grade 3 adverse reactions (fever: temperature ≥ 39.5 °C, swelling: area ≥ 50% of the injection site area) occurred in the IH group, and no Grade 3 adverse reactions occurred in the NH group. No serious adverse reactions occurred in either group. We conclude that for the NH group, two doses of quadrivalent influenza vaccine should be administered, and for the IH group, a one-dose regimen is acceptable.

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“…Available in 20 European markets, it will be planned to be launched in the future all around the world. It (32,33). In fact, the vaccine is a quadrivalent split-virion vaccine as a well-established record of Vaxigrip® (a trivalent split-virion flu vaccine) (34).…”

Section: Vaxigriptetra®: Quadrivalent Inactivated Influenza Vaccine (...mentioning

confidence: 99%

Highly Pathogenic Avian Influenza Vaccines: challenges for innovation, technological development and pandemic preparedness

Possas

Marques

Oliveira

et al. 2023

Preprint

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Introduction: Highly Pathogenic Avian Influenza (HPAI) pandemic potential is a critical issue. Outbreaks of H5N1 Avian Flu, causing mass die-offs in poultry and other birds, are now affecting mammals from otters to dolphins worldwide. H5N1 and other HPAI viruses have so far caused rare human infections. However, if they evolve to spread between people, they could trigger major outbreaks. The main question is: how to overcome bottlenecks in HPAI vaccine development to accelerate scale-up and implement an effective global Vaccine Preparedness System? Methods: From a patent landscape approach, we identified breakthroughs and gaps in HPAI vaccine development for the search period (2010-2021), discussing technological strategies in patent filings, including universal vaccine patent documents. Results: Very few patent documents for human HPAI vaccines were retrieved: from 49 deposits in the search period, only 18 were in active status (37%), with few breakthroughs and in early stages of development. These results indicate a technological lag in HPAI vaccine development and highlight the constraints for scaling-up these vaccines when they will be needed. Current egg-based processes are laborious and too difficult to scale-up in the case of a pandemic. Concerning mRNA technology, there are still issues on the duration and level of protection mRNA vaccines might induce. Vaccinating farm animals is not sufficient to protect the population: if not properly executed, the virus could continue to circulate at a low level, increasing the chance of mutations and adaptation to humans. Universal Influenza vaccines would be key, but we identified only few (20 in the search period) patents for these vaccines, still in early stages of development. In addition, it is the impact immunological memory would have on the development of protective immunity to a broad-spectrum of viruses, due to original antigenic sin mechanism. Discussion: This study identified critical barriers to overcome in HPAI vaccine development, improving efficacy and reducing costs. It highlights the urgent need for an effective global Vaccine Preparedness model, supported by Genomic, Antigenic and Epidemiological Surveillance, an Innovation Fund and Public-Private Partnerships. We strongly support WHO in coordinating a Global Initiative for Influenza Pandemic Preparedness.

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Safety of a quadrivalent influenza vaccine in Vietnamese healthy subjects aged 6 months and older

Cited by 6 publications

References 10 publications

Post-marketing Surveillance of a Quadrivalent Influenza Vaccine (Vaxigrip Tetra) in South Korea

Post-marketing Surveillance of a Quadrivalent Influenza Vaccine (Vaxigrip Tetra) in South Korea

Exploratory Study of the Phase IV Immunization Schedule of Quadrivalent Influenza Split-Virion Vaccine in Children Aged 3–8 Years

Highly Pathogenic Avian Influenza Vaccines: challenges for innovation, technological development and pandemic preparedness

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