NCT00971906已完成3 期
A Randomized, Single-blind, Dose-Ranging, Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and Non Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects 18 or More Years of Age
Novartis Vaccines4 个研究点 分布在 3 个国家目标入组 660 人开始时间: 2009年8月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 660
- 试验地点
- 4
- 主要终点
- To identify the preferred vaccine formulation, dosage (antigen & adjuvant), schedule (one or two administrations) of the H1N1 sw monovalent vaccine in adults
研究概览
简要总结
This present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of an adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy adult and elderly subjects. A booster dose will be administered 12 months after the first vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 18 years of age and above on the day of enrollment;
- •Individuals in good health
- •Individuals are able to comply with all study procedures
- •Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
排除标准
- •Individual not able to comprehend and to follow all required study procedures;
- •History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
- •Any serious chronic or progressive disease according to judgment of the investigator
- •History of any anaphylaxis, serious vaccine reactions, to any excipients.
- •Adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to Day 1;
- •Receipt of another investigational agent within 4 weeks prior to enrollment, or before completion of the safety follow-up period in this or in another study; unwilling to refuse participation in another clinical study through the end of this study;
- •Any other vaccines within 4 weeks prior to enrollment or who are planning to receive any vaccine within 4 weeks from the study vaccines; only exception being plain seasonal influenza vaccines which are allowed until 1 week prior to and after 1 week study vaccinations.
- •Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks;
- •Axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination;
- •Known or suspected impairment/alteration of immune function, for example resulting from a receipt of immunosuppressive therapy within 60 days prior to Visit 1;
- •History of progressive or severe neurological disorders;
- •Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule;
- •Female of childbearing potential, not used any acceptable contraceptive methods for at least 2 months prior to study entry;
- •Female pregnant or nursing (breastfeeding) mothers or females of childbearing potential do not plan to use acceptable birth control measures during the first 3 weeks after vaccination;
- •Members of the research staff or their relatives.
结局指标
主要结局
To identify the preferred vaccine formulation, dosage (antigen & adjuvant), schedule (one or two administrations) of the H1N1 sw monovalent vaccine in adults
时间窗: 43 days after first vaccination
次要结局
- To evaluate immunogenicity against A/California H1N1sw strain after booster dose of egg-derived seasonal trivalent, MF59 adjuvanted vaccine Fluad, recommended for 2010/2011 season, administered 12 months after primary course according to CHMP criteria(3 weeks after booster vaccination)
研究者
研究点 (4)
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