EUCTR2012-000063-24-IT进行中（未招募）不适用
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety & Immunogenicity of AGRIPPAL S1 Vaccine, Formulation 2012-2013, in Non-elderly Adult and Elderly Subjects - V71_32S
OVARTIS VACCINES AND DIAGNOSTICS S.R.L.0 个研究点开始时间: 2012年3月19日最近更新:
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
- •Male and female volunteers of 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry; Individuals able to comply with all the study requirements; Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 63
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 63
排除标准
- •Individuals with behavioral or cognitive impairment or psychiatric disease. Individuals with any serious chronic or acute disease (in the judgment of the investigator). Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine. Individuals with known or suspected (or have a high risk of developing) impairment/alteration of immune function. Individuals with known or suspected history of drug or alcohol abuse. Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time. Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study. Individuals with history or any illness that, in the opinion of the investigator, pose additional risk to the subjects due to participation in the study. Individuals who within the past 6 months have: - had any laboratory confirmed seasonal or pandemic influenza disease; - received any seasonal or pandemic influenza vaccine. Individuals who received any other vaccine within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine during the study. Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days. Individuals that have experienced fever (i.e., axillary temperature = 38°C) within the last 3 days of intended study vaccination. Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. Individuals who are part of study personnel or close family members conducting this study. BMI > 35 kg/m2. Females who are pregnant (confirmed by positive urine pregnancy test) or nursing (breastfeeding). Females of childbearing potential4 who refuse to use an acceptable method of birth control for the whole duration of the study.
研究者
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