NCT02825368Unknown4 期
Homeopathic Vaccine Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 4 期
- 试验地点
- 2
- 主要终点
- Antibody levels for tetanus
研究概览
简要总结
The purpose of the study is to compare the immunological response of homeopathic vaccines to placebo and to conventional vaccines in healthy young adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 18 and 24 years
- •Has received primary childhood DTaP and MMR vaccinations
- •Available for a follow up visit (3 weeks after initial visit)
排除标准
- •Received a live vaccine in the past 4 weeks
- •Has had a serious allergic reaction to a previous vaccination
- •Has allergies to one or more of the components of the vaccines to be used (Neomycin, egg protein)
- •Has a history of encephalopathy within 7 days of receiving DTP/DTap
- •Has received nosodes for Diphtheria, Tetanus, Pertussis, Measles and Mumps
- •Has received an adult booster dose of conventional vaccines of diphtheria, pertussis, tetanus, mumps, and measles (Tdap or MMR)
- •Has received immunosuppressive doses of steroids or anti-cancer drugs in the past 3 months
- •Is pregnant or if there is a chance they could become pregnant during the next month
- •Has a moderate to severe acute illness at the time of enrolment
- •Has cancer, leukemia, HIV/AIDS, or any other serious immune health condition
- •Has a history of Guillaume Barre Syndrome
- •Has received blood transfusion, blood products, or immune globulin within the past year
研究组 & 干预措施
Homeopathic vaccine group
Experimental
- Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes.
- Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo.
干预措施: Diphtherinum® (Other)
Homeopathic vaccine group
Experimental
- Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes.
- Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo.
干预措施: Pertussinum® (Other)
Homeopathic vaccine group
Experimental
- Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes.
- Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo.
干预措施: Tetanotxicum® (Other)
Homeopathic vaccine group
Experimental
- Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes.
- Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo.
干预措施: Morbilinum® (Other)
Homeopathic vaccine group
Experimental
- Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes.
- Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo.
干预措施: Ourlianum® (Other)
Homeopathic vaccine group
Experimental
- Diphtheria (Diphtherinum®), pertussis (Pertussinum®), tetanus (Tetanotxicum®), measles (Morbilinum®) and mumps (Ourlianum®) nosodes.
- Two sterile saline injections (0.5ml each, intramuscular and subcutaneous) as placebo.
干预措施: Sterile saline (Other)
Conventional vaccine group
Active Comparator
- One intramuscular dose of Tdap (tetanus, diphtheria, acellular pertussis)
- One subcutaneous dose of MMR (measles, mumps, rubella)
- Sugar pellets as placebo.
干预措施: MMR (Biological)
Conventional vaccine group
Active Comparator
- One intramuscular dose of Tdap (tetanus, diphtheria, acellular pertussis)
- One subcutaneous dose of MMR (measles, mumps, rubella)
- Sugar pellets as placebo.
干预措施: Tdap (Biological)
Conventional vaccine group
Active Comparator
- One intramuscular dose of Tdap (tetanus, diphtheria, acellular pertussis)
- One subcutaneous dose of MMR (measles, mumps, rubella)
- Sugar pellets as placebo.
干预措施: Sugar pellets (Other)
Control group
Placebo Comparator
- Sugar pellets oral dose
- Two sterile saline injections (0.5 ml each, intramuscular and subcutaneous) as placebo
干预措施: Sugar pellets (Other)
Control group
Placebo Comparator
- Sugar pellets oral dose
- Two sterile saline injections (0.5 ml each, intramuscular and subcutaneous) as placebo
干预措施: Sterile saline (Other)
结局指标
主要结局
Antibody levels for tetanus
时间窗: 3 weeks
Antibody levels for mumps
时间窗: 3 weeks
Antibody levels for diphtheria
时间窗: 3 weeks
Antibody levels for pertussis
时间窗: 3 weeks
Antibody levels for measles
时间窗: 3 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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