CTRI/2010/091/000152已完成1 期
A Phase I, Randomized, Double Blind, Placebo Controlled and Parallel Assignment Study to Evaluate the Safety and Efficacy of H1N1 Vaccine With or Without ajuvant Produced by BBIL in healthy volunteers. Acronym Influenza A H1N1 pandemic 2009 Vaccine(Inactivated)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- 1. Occurrence of solicited and unsolicited local AEs within 7 days post vaccination by age group and overall from Days 0 to 7.
研究概览
简要总结
This study is a Phase I, Randomized, Double Blind, Placebo Controlled and Parallel Assignment Study to Evaluate the Safety and Efficacy of Influenza A H1N1 pandemic 2009 Vaccine (Inactivated) With or Without Adjuvant Produced by Bharat Biotech International Limited in healthy volunteers in 160 healthy volunteer in one center in India. The primary objective of the study is to evaluate the safety of the cell cultured Influenza A H1N1 pandemic 2009 Vaccine (Inactivated) vaccine with or without an Adjuvant in healthy volunteers of 18 to 65 years. The secondary objective is to assess and obtain immunogenicity data of the cell cultured Influenza A H1N1 pandemic 2009 Vaccine (Inactivated) with or without an Adjuvant in healthy volunteers of 18 to 65 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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 hydroxide2.Has a history of previous severe allergic reaction with generalized urticaria, angioedema or anaphylaxis3.Female with positive urine pregnancy test within 24 hours prior to vaccination or breastfeeding or unwilling to undergo pregnancy testing4.History of smoking 20 pack-years or greater5.Has received anticancer chemotherapy or radiation therapy (cytotoxic) within the past 36 months6.Has an active neoplastic disease or a history of any hematologic malignancy7.Known history of a bleeding disorder contraindicating intramuscular vaccination8.History of schizophrenia, bipolar disease, suicidal attempt, major psychiatric illness or confinement for danger to self or others9.History of receiving immunoglobulin, anti-cytokine antibodies, immunosuppressants, immune modifying agents or other blood product within the 3 months prior to vaccination in this study10.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 study11.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 vaccination12.Has an acute illness, including an oral temperature greater than >370C, 1 week before the vaccination13.Has a chronic neurologic or autoimmune disorder14.Has a history of Guillain-Barré Syndrome15.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 response16.Participated in a novel influenza H1N1 vaccine study in the past two years or has a history of novel influenza H1N1 2009 infection or treatment17.Has known active HIV, Hepatitis B or Hepatitis C infection18.Has a history of alcohol or drug addiction in the last 5 years.
结局指标
主要结局
1. Occurrence of solicited and unsolicited local AEs within 7 days post vaccination by age group and overall from Days 0 to 7.
时间窗: Throughout Study Duration
2. Occurrence of solicited and unsolicited systemic AEs within 21 days post vaccination by age group and overall on Days 0, 7, 21,
时间窗: Throughout Study Duration
3. Occurrence of vaccine-associated SAEs throughout the course of the study by age group and overall.
时间窗: Throughout Study Duration
次要结局
- 1.Proportion of participants achieving 4-fold or greater HAI antibody titer increase against the novel influenza H1N1 virus following single dose of BBIL H1N1 vaccine groups on day 212.Proportion of participants achieving a serum HAI antibody titer of 1:40 or greater against the novel influenza H1N1 virus following single dose of BBIL H1N1 vaccine groups on Days 21.3.GMT in each group on day 0 and 21.(21 days post vaccination)
研究者
研究点 (1)
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