Guizhou Center for Disease Control and Prevention, Guiyang, China.
Sinovac Life Sciences Co., Ltd., China.
Vaccine. 2024 Aug 30;42(21):126182. doi: 10.1016/j.vaccine.2024.126182. Epub 2024 Aug 6.
This study was to assess the lot-to-lot consistency, immunogenicity and safety of three manufacturing lots of a quadrivalent inactivated influenza vaccine (IIV4).
A randomized, double-blind, phase IV clinical trial was conducted in healthy children, adolescents and adults aged 9-59 years in Guizhou Province, China. Eligible participants were enrolled and randomized into three groups in a ratio of 1:1:1 to receive a single dose of one of three manufacturing lots of IIV4. Serum samples were collected before and 28 days after vaccination for hemagglutination inhibition (HI) antibody testing. Safety data were collected for up to 28 days after vaccination. The primary objective was to evaluate the lot-to-lot consistency of immune response as assessed by the geometric mean titer (GMT) of HI antibody at 28 days after vaccination.
Between November 27, 2022 and December 18, 2022, 1260 eligible participants were enrolled, with similar participant demographics among groups. Immune responses after vaccination were comparable across groups, with the 95% confidence intervals (CIs) of GMT ratios for all 4 strains falling into the equivalence criterion of (0.67, 1.5). The seroconversion rates (SCRs) and seroprotection rates (SPRs) met the US Center or Biologics Evaluation and Research (CBER) criteria for all strains for each lot (lower limit of 95% CI of SCR ≥ 40% and SPR ≥ 70%). The incidences of solicited and unsolicited adverse reactions were similar among three groups, most of which (91.9%) were mild or moderate in severity. A total of 11 serious adverse events were reported during the study, and all were considered unrelated to vaccination.
The three manufacturing lots of IIV4 demonstrated consistent immunogenicity. IIV4 can elicit satisfactory immune responses for all four strains and no safety concerns were identified.
Identifier No. NCT05512494.
本研究旨在评估三批四价流感病毒裂解疫苗（IIV4）的批间一致性、免疫原性和安全性。
在中国贵州省，进行了一项随机、双盲、四期临床试验，纳入了 9-59 岁的健康儿童、青少年和成年人。合格的参与者按照 1:1:1 的比例被随机分配到三组，接受一剂三批中的任意一批 IIV4。接种前和接种后 28 天采集血清样本，用于血凝抑制（HI）抗体检测。接种后最多 28 天内收集安全性数据。主要目的是评估接种后 28 天 HI 抗体几何平均滴度（GMT）评估的免疫反应的批间一致性。
2022 年 11 月 27 日至 12 月 18 日，共纳入 1260 名合格参与者，各组参与者的人口统计学特征相似。各组接种后的免疫反应相似，所有 4 种毒株的 GMT 比值 95%置信区间（CI）均落入（0.67，1.5）等效标准范围内。各批的所有菌株的血清转化率（SCR）和血清保护率（SPR）均符合美国生物制品评价与研究中心（CBER）标准（SCR≥40%和 SPR≥70%的下限 95%CI≥40%）。三组的不良反应发生率相似，多数为轻度或中度（91.9%）。研究期间共报告 11 例严重不良事件，均认为与接种无关。
三批 IIV4 具有一致的免疫原性。IIV4 可对所有 4 种菌株引起满意的免疫应答，且未发现安全性问题。
标识符 No. NCT05512494。
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