Department of Pediatrics, S.S Institute of Medical Sciences and Research Center, Davangere, India.
Department of Pediatrics, Institute of Child Health, Kolkata, India.
Hum Vaccin Immunother. 2022 Nov 30;18(6):2104527. doi: 10.1080/21645515.2022.2104527. Epub 2022 Sep 2.
Efficacy and safety data on quadrivalent influenza vaccines (QIVs) for immunization of Indian children are scarce. This phase 3, registration study evaluated the immunogenicity, safety, and tolerability of a QIV in Indian children aged 6-35 months (Group 1) and 3-17 y (Group 2). Subjects received one or two doses (0.5 mL each) of the study vaccine based on their priming status. Immunogenicity (post-vaccination geometric mean fold increase in hemagglutination inhibition [HI] titers and proportion of patients with seroprotection and seroconversion against the four influenza strains), unsolicited adverse events (AEs), and tolerability were analyzed. Among 118 subjects enrolled in each group, the geometric mean(standard deviation) fold increase in HI titers against A(H3N2), A(H1N1), B(Victoria), and B(Yamagata) strains were 31.7(5.33), 10.5(6.06), 4.1(5.70), and 8.6(5.34) in Group 1 and 14.0(4.37), 9.2(4.26), 14.3(6.73), and 14.4(5.41) in Group 2, respectively. Seroprotection was achieved by 91.2%, 83.3%, 41.2%, and 68.4% subjects in Group 1 and 100%, 95.8%, 73.7%, and 89.8% subjects in Group 2, respectively. Seroconversion was achieved by 87.7%, 66.7%, 41.2%, and 64.9% subjects in Group 1 and 89.0%, 78.8%, 69.5%, and 75.4% subjects in Group 2, respectively. Vaccination site pain and fever were the most common local and systemic reactions, respectively. Systemic reactions were more frequent in Group 1 (16.9% vs 7.6%). Most subjects (>90%) did not experience inconvenience within 7 d of vaccination; <10% in both groups reported unsolicited AEs. Thus, the QIV had a positive benefit/risk profile in Indian children/adolescents aged 6 months to 17 y.: CTRI/2018/05/014191: Clinical Trials Registry - India: May 29, 2018: August 03, 2018 (first subject first visit) to January 31, 2019 (last subject last visit)Drugs Controller General of India [DCGI] permission letter number: CT-03/2018.
印度儿童接种四价流感疫苗(QIV)的疗效和安全性数据稀缺。这项 3 期注册研究评估了 QIV 在 6-35 月龄(第 1 组)和 3-17 岁(第 2 组)印度儿童中的免疫原性、安全性和耐受性。根据基础免疫状态,受试者接受一次或两次(每次 0.5 mL)研究疫苗接种。对血凝抑制(HI)滴度的几何平均倍数增加以及针对四种流感株的血清保护和血清转化率的患者比例等免疫原性(接种后)、不良事件(AE)和耐受性进行了分析。在每组纳入的 118 名受试者中,第 1 组和第 2 组的 HI 滴度针对 A(H3N2)、A(H1N1)、B(维多利亚)和 B(Yamagata)株的几何平均(标准差)倍数增加分别为 31.7(5.33)、10.5(6.06)、4.1(5.70)和 8.6(5.34),分别为 14.0(4.37)、9.2(4.26)、14.3(6.73)和 14.4(5.41)。第 1 组和第 2 组分别有 91.2%、83.3%、41.2%和 68.4%的受试者血清保护,100%、95.8%、73.7%和 89.8%的受试者血清转化率。第 1 组和第 2 组的血清转化率分别为 87.7%、66.7%、41.2%和 64.9%和 89.0%、78.8%、69.5%和 75.4%。接种部位疼痛和发热是最常见的局部和全身反应,分别。第 1 组的全身反应更常见(16.9%比 7.6%)。大多数受试者(>90%)在接种后 7 天内无不便;两组均<10%的受试者报告有不良事件。因此,QIV 在 6 个月至 17 岁的印度儿童/青少年中具有积极的收益/风险比。