Safety and immunogenicity of a quadrivalent inactivated subunit non-adjuvanted influenza vaccine: A randomized, double-blind, active-controlled phase 1 clinical trial
“…Of the 12 studies included, six were observer-blind, 13 , 23 , 31 , 33 , 35 , 36 and the rest were double-blind. 28–30 , 32 , 34 , 37 The clinical trials provided participant details comprising demographic characteristics, vaccination status (including unprimed and primed children, where the definition criteria were the same), and regional characteristics. Figure 1.…”
Section: Resultsmentioning
confidence: 99%
“…Three studies 23 , 35 , 37 have reported the SPRs for A/H1N1, A/H3N2, B/Victoria, and B/Yamagata among the population inoculated with either full-dose QIV or half-dose QIV. There were no significant differences in SPR for H1N1, H3N2, and B/Yamagata between full-dose QIV and half-dose QIV.…”
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.
“…Of the 12 studies included, six were observer-blind, 13 , 23 , 31 , 33 , 35 , 36 and the rest were double-blind. 28–30 , 32 , 34 , 37 The clinical trials provided participant details comprising demographic characteristics, vaccination status (including unprimed and primed children, where the definition criteria were the same), and regional characteristics. Figure 1.…”
Section: Resultsmentioning
confidence: 99%
“…Three studies 23 , 35 , 37 have reported the SPRs for A/H1N1, A/H3N2, B/Victoria, and B/Yamagata among the population inoculated with either full-dose QIV or half-dose QIV. There were no significant differences in SPR for H1N1, H3N2, and B/Yamagata between full-dose QIV and half-dose QIV.…”
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.
“…Currently in China, there are eight approved QIVs (including Sinovac Biotech, Beijing; and Hualan Biotech, Xinxiang, China) which are licensed for use in individuals aged ≥3 years and one approved in individuals aged 6 to 35 months (Hualan Biotech). 17 , 18 The national pharmacopoeia of China recommends that children aged <3 years receive the 0.25 mL dose (containing 7.5 μg hemagglutinin per virus strain) of any influenza vaccine, while globally a 0.5 mL dose (containing 15 μg hemagglutinin per virus strain) of influenza vaccine is more widely recommended in this age group. 19 Our study showed that the safety profiles of Shz QIV (0.25 mL) and Shz QIV (0.5 mL) were similar after the first and the second injections in those aged 6–35 months, suggesting that the increased dose does not compromise safety in this age group.…”
A quadrivalent, split-virion influenza vaccine (Shz QIV), containing two influenza A strains, and both B lineages strains, has been developed in China. We report the safety and immunogenicity of Shz QIV in two studies: a single-center, phase I, open-label, safety trial (n = 101) and a multicenter, phase III, observer-blind, randomized, safety and immunogenicity trial (n = 7,106) comparing Shz QIV with two trivalent influenza vaccines (Shz TIVs; one containing a B/Victoria-like strain and the other a B/Yamagata-like strain). Participants received one dose of Shz QIV (0.5 mL), except children aged 6 months to 8 years who received one or two doses (0.25 mL or 0.5 mL) depending on previous influenza vaccination. The Shz TIV groups received one or two (0.25 mL) doses depending on previous influenza vaccination (ages 6–35 months) or a single (0.5 mL) dose (ages ≥3 years). Immunogenicity was assessed at baseline and 28 days after the last dose, with safety assessed through to 6 months. The primary objective was to demonstrate the non-inferiority of antibody responses to Shz QIV (0.25 mL and 0.5 mL) versus Shz TIVs for each strain in ages 6–35 months and ≥3 years. Overall, Shz QIV was well tolerated, and showed similar safety to the Shz TIVs. Shz QIV (0.5 mL) induced non-inferior antibody responses to all antigens versus Shz TIV, with superiority demonstrated to the non-corresponding B strain in each TIV. Shz QIV (0.25 mL) non-inferiority in those aged 6–35 months was demonstrated for both A strains and the B/Yamagata-like strain, but not the B/Victoria-like strain. In summary, Shz QIV (0.5 mL) is immunogenic and has a good safety profile.
WHO Universal Trial Numbers (UTNs)
U1111-1174-4615 and U1111-1174-4698
ClinicalTrials.gov
NCT04210349 and NCT03430089
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