Mironov A N, Bushmenkov D S, Dyldina N V, Romanova A A, Tsaan A A, Kiselev O I, Erofeeva M K, Stukova M A
Zh Mikrobiol Epidemiol Immunobiol. 2010 May-Jun(3):32-5.
To study tolerability and safety of pandemic vaccines against influenza A/H1N1 "INFLUVIR" and "PANDEFLU" on limited group of volunteers during phase I clinical trial.
Thirty healthy volunteers were participated in phase I clinical trial. Clinical and laboratory tests of volunteers randomized to 2 groups (20 persons received vaccine and 10 persons - placebo) were performed. "INFLUVIR" vaccine was administered by intranasal route. Volunteers were hospitalized and followed up for development of local and systemic adverse events during 7 days after vaccination. "PANDEFLU" was administered intramuscularly; vaccinees were followed for 7 days in outpatient settings. RESULTS. Phase I clinical trial showed good tolerability and low reactogenicity of "INFLUVIR" and "PANDEFLU" vaccines. There were no moderate and severe local and systemic adverse events registered.
On the basis of performed phase I clinical trial, phase II trial was recommended to perform in order to assess the reactogenicity, safety and immunogenicity of studied vaccines.
在甲型H1N1流感大流行疫苗“INFLUVIR”和“PANDEFLU”的I期临床试验中，研究其在有限志愿者群体中的耐受性和安全性。
30名健康志愿者参与了I期临床试验。对随机分为2组的志愿者（20人接种疫苗，10人接种安慰剂）进行了临床和实验室检查。“INFLUVIR”疫苗通过鼻内途径给药。志愿者住院，并在接种疫苗后7天内对局部和全身不良事件的发生情况进行随访。“PANDEFLU”通过肌肉注射给药；接种疫苗者在门诊环境中随访7天。结果。I期临床试验表明，“INFLUVIR”和“PANDEFLU”疫苗耐受性良好且反应原性低。未记录到中度和重度局部及全身不良事件。
基于所进行的I期临床试验，建议进行II期试验，以评估所研究疫苗的反应原性、安全性和免疫原性。
