CTRI/2010/091/000661已完成2 期
A Phase II/III, Multi-center, Randomized, Double Blind, Placebo Controlled and Parallel Assignment Study to Evaluate the Safety and Efficacy of HN-VAC (Influenza A/H1N1 Adjuvant vaccine) Produced by BBIL in healthy volunteers.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Healthy male or female volunteers aged between 18 to 65 years inclusive
- •2.Subjects of child-bearing potential must agree to practice adequate contraception that may include, but is not limited to, abstinence, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods during the study for at least 30 days following the last vaccination
- •3.The subject must be in good health as determined by medical history, physical examination and laboratory screening tests
- •4.Subject must be willing and able to comply with planned study procedures and be available for all study visits
- •5.Subject must provide written informed consent prior to initiation of any study procedures, and subject may provide written assent as appropriate
- •6.Subjects willing to stay for entire study duration and follow-up period in the current residential address.
排除标准
- •1.Allergy to components of the vaccine including, thiomersal, and aluminum hydroxide
- •2.Has a history of previous severe allergic reaction with generalized urticaria, angioedema or anaphylaxis
- •3.Female with positive urine pregnancy test within 24 hours prior to vaccination or breastfeeding or unwilling to undergo pregnancy testing
- •4.History of smoking 20 pack-years or greater
- •5.Has received anticancer chemotherapy or radiation therapy (cytotoxic) within the past 36 months
- •6.Has an active neoplastic disease or a history of any hematologic malignancy
- •7.Known history of a bleeding disorder contraindicating intramuscular vaccination
- •8.History of schizophrenia, bipolar disease, suicidal attempt, major psychiatric illness or confinement for danger to self or others
- •9.History of receiving immunoglobulin, anti-cytokine antibodies, immunosuppressants, immune modifying agents or other blood product within the 3 months prior to vaccination in this study
- •10.Has received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 3 months prior to vaccination in this study or expected to receive an experimental agent during this study
- •11.Has received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study, or plan receipt of such vaccines within 21 days following the second vaccination
- •12.Has an acute illness, including an oral temperature greater than >37 C, 1 week before the vaccination
- •13.Has a chronic neurologic or autoimmune disorder
- •14.Has a history of Guillain-Barré Syndrome
- •15.Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, or would interfere with the evaluation of vaccine response
- •16.Participated in a novel influenza H1N1 vaccine study in the past two years or has a history of novel influenza H1N1 2009 infection or treatment
- •17.Has a history of alcohol or drug addiction in the last 5 years
研究者
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