EUCTR2009-013904-30-IT进行中（未招募）不适用
A Phase II, Open Label Study to Evaluate the Immunogenicity, Tolerability and Safety of a MF59-Adjuvanted, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects Aged 18 Years and Above - ND
OVARTIS VACCINES AND DIAGNOSTICS S.R.L.0 个研究点开始时间: 2009年7月17日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. For study Groups A and B : Males and females aged 18 years and above on the day of enrollment, who took part to the Agrippal S1 or Fluad trials (V71_10S and V70_9S, respectively) for the 2009/10 vaccine registration; For study Groups C to E: Males and females aged 18 years and above on the day of enrollment, not yet exposed to the current seasonal formulation (2009/10 for NH) of the influenza vaccines; 2. Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator; 3. Documented consent obtained after the nature of the study has been explained according to local regulatory requirements; 4. Individuals 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? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study or who do not consent to the retention of the subject?s serum samples after study completion; 2. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject`s ability to participate in the study; 3. 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; 4. Individuals who have had received an influenza vaccine for the 2009/10 NH influenza season (for subjects to be included in Groups C to E only) prior to Visit 1; 5. Individuals who have had documented confirmed or suspected influenza disease within 6 months prior to Day 1. 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 participation in another clinical study through the end of this study; 7. Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines; 8. Individuals who have ever 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 (≥ 38.5C, if measured orally or rectally) 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 known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis (15 mg/day of prednisone or its equivalent) or chronic use of inhaled high-potency corticosteroids (e.g. budesonide 800?g/day or fluticasone 750?g/day) within 60 days prior to Visit 1, 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 neurological disorders (including Guillain-Barre` syndrome and convulsions, but excluding febrile convulsions); 12. History of or clinically suspected developmental delay 13. Bleeding diathesis;
研究者
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