Serum Institute of India Ltd., Pune, India.
Vaccine. 2012 Dec 17;31(1):20-2. doi: 10.1016/j.vaccine.2012.10.081. Epub 2012 Nov 4.
An alum adjuvanted whole virion inactivated vaccine against the A (H1N1) 2009 pandemic virus was developed in India. Two double-blind, randomized studies were conducted. Fifty adults (18-50 years) were enrolled in the Phase I study, whereas the Phase II/III study consisted of 330 adults (≥18 years) and children ≥3 years. Safety (both studies) and immunogenicity (Phase II/III study) by hemagglutination inhibition (HI) antibody titers, of 10 μg or 15 μg of hemagglutinin (HA) antigen were compared. In the Phase I study, mostly mild and transient injection site and systemic reactions were reported. Similar events were seen in the Phase II/III study. The overall seroprotection was 96% and 89% with 10 and 15 μg doses, respectively, while the seroconversion was 92% and 88%. The new Indian-made pandemic H1N1 vaccine is safe and immunogenic in adults and children above 3 years of age.
一种针对 A (H1N1) 2009 大流行病毒的含明矾佐剂全病毒灭活疫苗已在印度开发。进行了两项双盲、随机研究。50 名成年人（18-50 岁）参加了 I 期研究，而 II/III 期研究包括 330 名成年人（≥18 岁）和≥3 岁的儿童。通过血凝抑制（HI）抗体滴度比较了 10 μg 或 15 μg 血凝素（HA）抗原的安全性（两项研究）和免疫原性。在 I 期研究中，主要报告了轻度和短暂的注射部位和全身反应。在 II/III 期研究中也观察到类似的事件。总体血清保护率分别为 96%和 89%，10 μg 和 15 μg 剂量分别为 92%和 88%。新的印度制造的大流行 H1N1 疫苗在 3 岁以上的成年人和儿童中是安全和免疫原性的。
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