CTRI/2009/091/000539已完成4 期
A multicentric, single blind, parallel, randomized phase-IV study to evaluate the immunogenicity & safety of a single booster dose of BEs Tetanus Toxoid vaccine BETT administered to healthy Indian adults of either gender aged between 18-50 years in comparison with the marketed ShanTT® vaccine - A non-inferiority study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Non-inferiority(NI)assessment by proportions
研究概览
简要总结
A multicentric, single blind, parallel, randomized (2:1) phase-IV study to evaluate the immunogenicity & safety of a single booster dose of BE?s Tetanus Toxoid vaccine BETT administered to healthy Indian Adults of either gender aged between 18-50 years in comparison with the marketed ShanTT® vaccine conducted in three centres in India. The primary outcome measure is to demonstrate non-inferiority of BE?s monovalent Tetanus Toxoid vaccine (BETT) compared to ShanTT® in terms of proportion of subjects seroprotected. The secondary outcomes will be to assess non inferiority in terms of GMTs, assess booster responses, seroconversion and seroprotection rates & safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Written informed consent obtained from the subject or his/her legally acceptable representative; 2) Healthy Indian subjects of either gender aged between 18-50 yrs of age; 3) Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature >39.5 degrees); 4) History of previous immunisation with TT; 5) Subjects without any history of contagious diseases.
排除标准
- •Subjects with acute disease at the time of enrolment, defined as presence of a moderate or severe illness;2) Clinical or serological findings suggestive of any contagious disease at the time of screening; 3) Known case of hypersensitivity to any of the components of TT vaccine;4) Known history of any Serious Adverse Reaction (SAR) with previous TT immunizations in the individual to be immunized;5) Any criteria, which in the opinion of the Investigator, suggests that the subject would not be compliant with the study protocol.
结局指标
主要结局
Non-inferiority(NI)assessment by proportions
时间窗: Non-inferiority margin set at -10% assessed after 30 days of single booster dose.
次要结局
- 1. Non-inferiority (NI) by Geometric Mean titer ratio;2. Anti-Tetanus booster responses assessed by fold increase in titers;3. proportion of subjects seroconverted (SCR ≥0.01 IU/mL) and seroprotected (SPR ≥0.1 IU/mL).4. Occurrence of solicited and unsolicited local and general adverse events(1. Ratio set at > 1/1.5 assessed 30 days after single booster dose.2. 30 days after single booster dose3. 30 days after single booster dose.4.first 7 days after single dose and next 28 days thereafter and serious adverse events during the entire study period.)
研究者
研究点 (3)
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