CTRI/2011/04/001700已完成1/2 期
An open label, multicentric, phase I/II clinical trial to assess the immunogenicity and safety of Inactivated Influenza Vaccine (Whole Virion) IP, Trivalent in healthy adult subjects
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- 2.Increase in Geometric Mean Titre (GMT)
研究概览
简要总结
This study is an open label, single treatment arm study to assess the immunogenicity and safety of Inactivated Influenza Vaccine (Whole Virion) IP,Trivalent given as 0.5 ml single I.M. injection in healthy adult subjects that will be conducted in India with a follow-up period of 42 days. The primary outcome measure will be the immunogenicity assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy volunteers of the age 18-60 years age.
- •2.If female, not pregnant or lactating at the time of enrolment and not planning pregnancy during the study period.
- •3.Subjects likely to be available for all visits during the follow-up period.
- •4.Informed consent of the subject/relative.
排除标准
- •1.Pregnancy & Lactation.
- •2.Subjects with a history of anaphylaxis or serious reactions to vaccines; influenzal viral protein, egg proteins, neomycin or polymyxin.
- •3.Subjects who are taking immunostimulant therapy or immunosuppressant medications.
- •4.Subjects who are known to be suffering from diseases which can affect immune competence.
- •5.Subjects who have received blood products or immunoglobulins parenterally during the preceding 3 months.
- •6.Subjects who have recently had acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy.
- •7.Subjects having received influenza vaccine within the previous six months.
- •8.Subjects who have received any other vaccine or investigational medicinal product in the preceding 3 months.
- •9.Subjects with any other clinically significant concurrent illness.
- •10.Subjects with continuing history of alcohol and / or drug abuse.
结局指标
主要结局
2.Increase in Geometric Mean Titre (GMT)
时间窗: Day 0 & Day 21
1.Number of seroconversions or significant increase in anti-haemagglutinin antibody titre
时间窗: Day 0 & Day 21
3.The proportion of subjects achieving an HI titre more than or equal to 1:40
时间窗: Day 0 & Day 21
次要结局
- Safety Assessments(Day 0, 7, 21 & 42)
研究者
研究点 (2)
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