Dose Comparison Study of Tuberculin Purified Protein Derivative (PPD)With Standard Tuberculin Purified Protein Derivative.
试验速览
- 阶段
- 2 期
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Confirm the potency of Aplisol equipotent to PPD-S2.
研究概览
简要总结
Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the standard tuberculin purified derivative (PPD-S2).
详细描述
JHP proposes to demonstrate clinical comparability of Aplisol formulated from the new Tuberculin PPD drug substance to the standard PPD-S2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or nonpregnant females age 18 to 60 years
- •Documented PPD reactivity of 5 to 21 mm in the past, documented in a medical record. Self-reported PPD reactivity will be accepted if medical records cannot be obtained.
- •Give written informed consent to participate
- •Generally healthy, as determined by medical history and targeted physical examination, if indicated
- •Possess 2 forearms that are free of burns, scars, eczema, or any physical deformity, which could impair injection of study preparation or the readings of the injections
- •Comprehension of the study requirements; expressed availability for the required study period, including readings at the nominal time points of 48 and 72 hours
排除标准
- •Prior PPD test within the past 30 days
- •Subject is of childbearing potential and unable to use contraceptives; is planning pregnancy; is pregnant or lactating
- •History of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration, necrosis) or other severe reaction to PPD in the past
- •Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born or lived outside the US as a child and is uncertain of his/her BCG vaccination status
- •Presence of conditions that may suppress TST reactivity
研究组 & 干预措施
Aplisol, potency determination
To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.
干预措施: To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard. (Biological)
Aplisol, potency determination
To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.
干预措施: Reactivity of Aplisol compared to reference standard PPD-S2. (Biological)
Reference standard PPD-S2, reference
Reactivity of Aplisol compared to reference standard PPD-S2.
干预措施: To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard. (Biological)
Reference standard PPD-S2, reference
Reactivity of Aplisol compared to reference standard PPD-S2.
干预措施: Reactivity of Aplisol compared to reference standard PPD-S2. (Biological)
结局指标
主要结局
Confirm the potency of Aplisol equipotent to PPD-S2.
时间窗: 72 hours
次要结局
- Assess tolerability of Aplisol with new tuberculin PPD(72 hours)