EUCTR2009-013640-37-BE进行中（未招募）1 期
A Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and non Adjuvanted Cell-derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects from 6 Months to 17 Years of Age
ovartis Vaccines and Diagnostics S.r.l.0 个研究点目标入组 720 人开始时间: 2009年7月22日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 720
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Males and females 6 months of age to 17 years of age on the day of enrollment;
- •2. Subject's parents or legal guardians who have given written consent and the subjects has given assent consent, if applicable, after the nature of the study has been explained according to local regulatory requirementsable to comply with all study procedures and requirements;
- •3. Individuals in good health as determined by the outcome of medical history; physical examination and clinical judgment of the investigator;
- •4. Subjects, subject's parents or legal guardians that are able to comply with all study procedures and are available for all clinic visits scheduled in the study.
- •5. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject's parents or legal guardians who are not able to comprehend and to follow
- •all required study procedures for the whole period of the study;
- •2. Individuals with history or any illness that, in the opinion of the investigator,
- •might interfere with the results of the study or pose additional risk to the subjects
- •due to participation in the study;
- •3. Individuals with any serious chronic or progressive disease according to judgment
- •of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic
- •4. History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to
- •influenza viral proteins, to any excipients, and to eggs (including ovalbumin),
- •chicken protein;
- •5. Individuals who have had adjuvanted influenza vaccine or documented confirmed
- •or suspected influenza disease within 3 months prior to Day 1.
- •Documented-confirmed” includes:
- •a. Positive serology result
- •b. Positive viral culture
- •c. Positive rapid antigen test
- •d. Suspected” influenza disease includes: subjects with influenza-like illness
- •within the past 3 months with a household/intimate contact with
- •laboratory-confirmed” influenza disease;
- •6. 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 a participation in another clinical study through the end of this
- •7. Individuals who receive any other vaccine 4 weeks prior to enrolment in this study
- •or who are planning to receive any vaccine within four weeks from the study
- •vaccines; the only exception being plain seasonal influenza vaccines which are
- •allowed until one week prior to and after one week for the first two study
- •vaccinations. Individuals who have received any influenza vaccine for the 2010 /
- •2011 season or for the 2010 Southern Hemisphere season less than 8 months
- •before the booster dose. Individuals who have received the monovalent H1N1
- •pandemic vaccine outside this protocol less that 8 months before the booster dose
- •8. Individuals who have received blood, blood products and/or plasma derivatives or
- •any parenteral immunoglobulin preparation in the past 12 weeks;
- •9. Individuals with axillary temperature = 38.0 degrees Celsius (=100.4 F) or
- •oral/rectal temperature = 38.5 degrees Celsius (=101.3 F) within 3 days of
- •intended study vaccination;
- •10. Known or suspected impairment/alteration of immune function, for example
- •resulting from:
- •a. receipt of immunosuppressive therapy such as systemic corticosteroids at
- •any dose or chronic use of inhaled high-potency corticosteroids (e.g.
- •budesonide 800µg/day or fluticasone 750µg/day) within 60 days prior to
- •b. cancer chemotherapy,
- •c. receipt of immunostimulants within 60 days prior to Visit 1,
- •d. receipt of parenteral immunoglobulin preparation, blood products, and/or
- •plasma derivatives within 3 months prior to Visit 1 or planned during the
- •full length of the study,
- •e. known HIV infection or HIV-related disease;
- •11. History of progressive or severe neurologic disorder (including Guillain-Barré
- •syndrome, history of hyporesponsive episode, and convulsion, but excluding
- •febrile convulsion);
- •12. History of or clinically suspected developmental delay;
- 另有 5 项未显示
研究者
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