Immunogenicity and safety of three 2010–2011 seasonal trivalent influenza vaccines in Chinese toddlers, children and older adults

Luo, Fengguang; Yang, Liqing; Ai, Xing; Bai, Yunhua; Wu, Jiang; Li, Shu-Ming; Zhang, Zheng; Lu, Minjie; Li, Li; Wang, Zhao-Yun; Shi, Nianmin

doi:10.4161/hv.24832

Cited by 9 publications

(10 citation statements)

References 9 publications

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“…No serious or life-threatening AE was reported. This result is similar to that of a clinical trial conducted in China in 2013, 11 which demonstrated that all 3 TIVs were well tolerated. However, we observed a higher incidence of systemic reactions with the imported influenza vaccine (GSK TIV) than with the 2 domestic vaccine (Sinovac TIV and Pasteur TIV).…”

Section: Resultssupporting

confidence: 88%

Safety and immunogenicity of 3 seasonal trivalent influenza vaccines in the Chinese military

Gao

Yang

Deng

et al. 2016

Human Vaccines & Immunotherapeutics

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Influenza, caused by the influenza virus, is a contagious acute viral respiratory disease with a high incidence rate and wide and rapid spread. Influenza-related morbidity, mortality, and hospitalization rates remain high and are increasing continuously in high-risk groups, with a significant impact on human health and the economy. In order to evaluate the immunogenicity of 3 seasonal trivalent influenza vaccines in Chinese military, we conducted this field trial. We assessed the safety and immunogenicity of 3 seasonal trivalent influenza vaccines(TIVs)manufactured by GlaxoSmithKline(GSK), Beijing Sinovac Biotech (Sinovac), and Shenzhen Sanofi Pasteur (Pasteur) in healthy Chinese servicemen. We used theimported GSKTIV as the control, comparing it with the 2 domestic TIVs in a 1:1:1randomized, double-blind, controlled trial in a military command in Beijing. Healthy individuals, aged between 18 and 34 years, who had not received any influenza vaccine in the preceding3 years were enrolled and administered one dose of a TIV. Safety data were collected throughout the whole study (day 0 to day 30). Blood samples were collected to assess the subjects' immunogenicity before vaccination and 21 d after vaccination. In total, 292 subjects enrolled in the study. Twelve participants (4.1%) reported 12 adverse events. The incidence of adverse events was 1%, 5%, and7% for the GSK, Sinovac, and Pasteur TIVs, respectively. The reported injection-site reaction frequencies were similar for all 3 TIVs (p = 0.217). However, the proportion of systemic reactions was higher after the GSKTIV than after the Pasteur or Sinovac TIV (7.1% vs 3.1% or1%, respectively; p = 0.020). Three TIVs satisfied both the European and US Food and Drug Administration criteria for H1N1–179, H1N1–74, H3N2, and B strains based on the post vaccination sero-protection, the sero-conversion rate, and the geometric mean titer ratio. The Sinovac TIV, Pasteur TIV, and GSK TIV were well tolerated and immunogenic in healthy servicemen in the military. There was no significant difference in the immunogenicity of these 3 vaccines.

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Section: Resultssupporting

confidence: 88%

Safety and immunogenicity of 3 seasonal trivalent influenza vaccines in the Chinese military

Gao

Yang

Deng

et al. 2016

Human Vaccines & Immunotherapeutics

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“…31 In the 2010/2011 season, obvious immune response was observed in both children and the elderly. 32 The seroprotection rates against H1N1 and H3N2 were more than 70% in children and more than 60% in the elderly, and the seroconversion rates against the 2 strains were all more than 30%. The seroprotection rate against B antigen was more than 30% in both children and the elderly and the seroconversion rates was more than 20%.…”

Section: Rapid Immune Responsementioning

confidence: 93%

“…Clinical data in this review on Anflu ® comes from pre-market licensure trial, 21 annual trials sponsored by Sinovac Biotech [22][23][24][25][26][27][28][29][30][31] (Table 1) and investigator-initiated clinical trials. [32][33][34]…”

Section: Anflu®: a Preservative-free Unadjuvanted Split-virus Tivmentioning

confidence: 99%

“…With a few exceptions (2006 and 2011), immunogenicity assays were performed in the adults aged 18-60 y and the elderly >60 y in annual studies. 22,23,26,28,31,32 According to the European Medicines Agency guidelines, >50 subjects were included in each of these age groups. Serum samples were collected immediately before and generally 21 d after vaccination.…”

Section: Immunogenicitymentioning

confidence: 99%

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Review of 10 years of clinical experience with Chinese domestic trivalent influenza vaccine Anflu^®

Liu

Wang

et al. 2013

Human Vaccines & Immunotherapeutics

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Influenza viruses cause annual winter epidemics globally and influenza vaccination is most effective way to prevent the disease or severe outcomes from the illness, especially in developing countries. However, the majority of the world's total production capacity of influenza vaccine is concentrated in several large multinational manufacturers. A safe and effective preventive vaccine for the developing countries is urgent. Anflu®, a Chinese domestic preservative-free, split-virus trivalent influenza vaccine (TIV), was introduced by Sinovac Biotech Ltd. in 2006. Until now, 20.6 million doses worldwide of Anflu® were sold. Since 2003, 13 company-sponsored clinical studies investigating the immunogenicity and safety of Anflu® have been completed, in which 6642 subjects participated and were vaccinated by Anflu®. Anflu® was generally well tolerated in all age groups, and highly immunogenic in healthy adults and elderly and exceeded the licensure criteria in Europe. This review presents and discusses the experience with Anflu® during the past decade. A new Chinese domestic, preservative-free, unadjuvanted, inactivated split-virus trivalent influenza vaccine (TIV), Anflu®, was introduced into human clinical trials in 2003 and then licensed in China in 2006. The vaccine contains 15 µg/0.5 ml hemagglutinin from each of the 3 influenza virus strains (including an H1N1 influenza A virus subtype, an H3N2 influenza A virus subtype, and an influenza B virus) that are expected to be circulating in the up-coming influenza season. The clinical data pertaining to Anflu® will be reviewed and compared with other TIVs available at present.

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“…Literally the split-vaccines are "the happy medium" in influenza prophylaxis because the level of their side effects is similar to that of subunit vaccines and their immunological effectiveness is analogous to the same of whole-virus vaccines. [5][6][7] Influenza vaccine production capacity all over the world is 350 million doses per year. In case of pandemic the world vaccine manufacturing companies will fail to meet the global demand.…”

mentioning

confidence: 99%

Safety and immunogenicity of the novel seasonal preservative‐ and adjuvant‐free influenza vaccine: Blind, randomized, and placebo‐controlled trial

Sarsenbayeva¹,

Volgin²,

Kassenov³

et al. 2017

Journal of Medical Virology

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The producers of influenza vaccines are not capable today to meet the global demand for an influenza vaccine in case of pandemic, so the World Health Organization recommends to develop the own influenza vaccine production in each country. A domestic preservative- and adjuvant-free trivalent split vaccine against seasonal influenza was developed at the Research Institute for Biological Safety Problems. The paper presents the results of assessing safety and immunogenicity of the influenza split vaccine after single immunization of healthy volunteers aged 18-50 years in the course of Phase I Clinical Trials. This study was randomized, blind, and placebo-controlled. The volunteers were intramuscularly vaccinated with a dose of split vaccine or placebo. The study has shown that all local and systemic reactions had low degree of manifestation and short-term character, so there was no need in medication. Serious side effects were not observed. On day 21 post vaccination the portion of vaccinated persons with fourfold seroconversions to influenza А/H1N1pdm09 virus was 100.0%, to influenza А/H3N2 virus-95.5%, to influenza B virus-81.8%, and in placebo group this index was 0%. Seroprotection rates against influenza А/H1N1pdm09, А/H3N2 and B viruses were 95.5, 86.3, and 72.7%, respectively. Geometric mean titers (GMT) of antibodies by day 21 post vaccination reached 175.7 for influenza А/H1N1pdm09 virus, 64.2 for influenza А/H3N2 virus, and 37.6 for influenza B virus; in placebo group GMT growth was not observed. So, the seasonal influenza split vaccine is well tolerated and fits all immunogenicity criteria for human influenza vaccines.

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Immunogenicity and safety of three 2010–2011 seasonal trivalent influenza vaccines in Chinese toddlers, children and older adults

Cited by 9 publications

References 9 publications

Safety and immunogenicity of 3 seasonal trivalent influenza vaccines in the Chinese military

Safety and immunogenicity of 3 seasonal trivalent influenza vaccines in the Chinese military

Review of 10 years of clinical experience with Chinese domestic trivalent influenza vaccine Anflu^®

Safety and immunogenicity of the novel seasonal preservative‐ and adjuvant‐free influenza vaccine: Blind, randomized, and placebo‐controlled trial

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Immunogenicity and safety of three 2010–2011 seasonal trivalent influenza vaccines in Chinese toddlers, children and older adults

Cited by 9 publications

References 9 publications

Safety and immunogenicity of 3 seasonal trivalent influenza vaccines in the Chinese military

Safety and immunogenicity of 3 seasonal trivalent influenza vaccines in the Chinese military

Review of 10 years of clinical experience with Chinese domestic trivalent influenza vaccine Anflu®

Safety and immunogenicity of the novel seasonal preservative‐ and adjuvant‐free influenza vaccine: Blind, randomized, and placebo‐controlled trial

Contact Info

Product

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Review of 10 years of clinical experience with Chinese domestic trivalent influenza vaccine Anflu^®