Erofeeva M K, Mel'nikov S Ia, Semchenko A V, Korovkin S A, Nikonorov I Iu, Maksakova V L, Voĭtsekhovskaia E M, Erman E S, Gonchar V V, Pozdeev V K, Drinevskiĭ V P
Zh Mikrobiol Epidemiol Immunobiol. 2010 Mar-Apr(2):55-9.
Assessment of reactogenicity, safety and immunogenicity after single intramuscular immunization of children with Grifor vaccine.
Reactogenicity, safety, and immunogenicity of Grifor vaccine compared with Vaxigrip vaccine was evaluated during phase III clinical trial in the Institute of Influenza. Thirty-six children aged 12 - 17 years, divided on 2 groups, participated in single blind comparative prospective randomized trial. Seroconversion factor, seroconversion and seroprotection levels were evaluated by hemagglutination inhibition assay.
Results of study of systemic and local reactogenicity in children during first 7 days after immunization with Grifor and Vaxigrip vaccine showed good tolerability, areactogenicity and safety of both vaccines. Complete blood count, serum biochemistry and urinalysis results as well as serum IgE level did not change after vaccination. After immunization with Grifor vaccine, seroconversion rate to influenza virus subtypes A/H1N1, A/H3N2, and B was 70%, 50%, and 70% respectively, seroprotection rate--90%, 80%, and 85% respectively, and seroconversion factor--6.5, 2.7, and 4.0 respectively.
This trial, which was performed in tightly controlled conditions, had demonstrated that Grifor vaccine is safe and highly immunogenic against influenza viruses A and B and satisfies criteria of both Federal Service for Surveillance for Protection of Consumers Rights and Human Welfare and CHMP of EMA. Obtained results allow to recommend the Grifor vaccine for use in pediatric practice according to national immunization schedule.
评估儿童单次肌内注射格里福疫苗后的反应原性、安全性和免疫原性。
在流感研究所进行的III期临床试验中，对格里福疫苗与维克菲克疫苗相比的反应原性、安全性和免疫原性进行了评估。36名12至17岁的儿童分为两组，参与了单盲比较前瞻性随机试验。通过血凝抑制试验评估血清转化因子、血清转化率和血清保护水平。
对儿童接种格里福疫苗和维克菲克疫苗后前7天的全身和局部反应原性研究结果显示，两种疫苗耐受性良好、无反应原性且安全。接种疫苗后全血细胞计数、血清生化和尿液分析结果以及血清IgE水平均未改变。接种格里福疫苗后，对甲型H1N1、甲型H3N2和乙型流感病毒的血清转化率分别为70%、50%和70%，血清保护率分别为90%、80%和85%，血清转化因子分别为6.5、2.7和4.0。
在严格控制的条件下进行的该试验表明，格里福疫苗对甲型和乙型流感病毒安全且具有高度免疫原性，符合俄罗斯消费者权益保护和公益监督局以及欧洲药品管理局人用医药产品委员会的标准。获得的结果允许根据国家免疫规划推荐格里福疫苗用于儿科实践。
