"Clinical Trial Protocol for Evaluation of Immunogenicity and Safety of Rabies Vaccine Human (Cell Culture) I.P. in post exposure subjects"
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Immunogenicity and safety profile will be evaluated and compared with that of the reference vaccine in the study population by estimating the percentage seroconversion.The seroconversion in the subjects will be evaluated.
研究概览
简要总结
The purpose of this Clinical Trial was to compare Immunogenicity and safety of Rabies Vaccine Sure Rab manufactured by Biomed Private Limited with the Vero Rab manufactured by Aventis Pasteur in post exposure subjects.
Objectives:
-
For Evaluation of Immunogenicity and safety of Rabies Vaccine Human (Cell Culture) I.P. in post exposure subjects.
-
Subjects were divided into three groups:-
-
Group I : Immunized by Essen regimen with Sure Rab.
-
Group II: Immunized by Thai Red Cross regimen Sure Rab.
-
Group III: Immunized by Essen regimen with Vero Rab.
All volunteers of test and comparator vaccine achieved the protective level on Day 14.
Results were submitted to DCGI and sale permission is granted by DCGI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 2.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject is bitten by suspect rabid animal and having either category II or III exposure as assessed by history,physical examination and clinical judgment of the investigator.
- •2.Subject is of age group (2 to 65)years.
- •3.Subject is of Indian origin and will remain in the study area for the length of the trial.
- •4.Subject should accept written and inform consent.
- •5.Subject is aware of full information regarding the vaccine and clinical trial.
排除标准
- •1.History of allergy or hypersensitivity to any component of the vaccine.
- •2.History of Rabies immunization.
- •3.Person participating in any other study at the same time or during the past three months.
- •4.Surgery planned during the study period.
- •5.Person known to be HIV positive.
- •Pregnant women.
- •7.Infants and children ≤2 years of age.
结局指标
主要结局
Immunogenicity and safety profile will be evaluated and compared with that of the reference vaccine in the study population by estimating the percentage seroconversion.The seroconversion in the subjects will be evaluated.
时间窗: The rabies antibody titers shall be analysed for seroconversion(≥ 0.5 IU/ml)
次要结局
未报告次要终点