NCT00694460已完成2 期
A Phase II, Pilot, Randomized, Open-Label, Single-Center Study to Evaluate Immunogenicity, Safety and Booster Response of 3 Full Intramuscular Doses Versus 3 Half Intramuscular Doses Versus 3 Intradermal Doses Versus 2 Intradermal Doses of PCEC Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine as a Pre-Exposure Regimen in 12 to 18 Months Old Toddlers in Thailand.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Rabies virus neutralizing antibody concentrations
研究概览
简要总结
This study evaluated the safety and immunogenicity of rabies vaccine and Japanese encephalitis vaccine in toddlers. All children developed adequate immune responses. Rabies vaccination with PCECV did not interfere with the antibody response to Japanese encephalitis vaccine. The rabies vaccine PCECV and Japanese encephalitis vaccine are safe and immunogenic when administered concomitantly to toddlers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female 12-18 months old toddlers if they
- •are in good health at time of entry into the study
- •are available for all the visits scheduled in the study
- •have been granted a written informed consent, signed by their parents
排除标准
- •a history of rabies immunization
- •a history of Japanese encephalitis immunization or disease
- •a significant acute or chronic infectious disease at the time of enrollment
- •fever ≥ 38.0°C (axillary) or/and significant acute or chronic infection requiring antibiotic or antiviral therapy within the past 7 days before enrollment
- •being under treatment with corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment
- •administration of any vaccine within the past 14 days before enrollment
- •known immunodeficiency or an autoimmune disease
- •history of allergy to eggs, egg products
- •known hypersensitivity to neomycin, tetracycline, amphotericin-B
- •planned surgery during the study period
- •being enrolled in any other investigational trial contemporaneously
- •the family plans to leave the area of the study site before the end of study period
- •history of febrile convulsions
- •history of wheezing
结局指标
主要结局
Rabies virus neutralizing antibody concentrations
时间窗: 2 years
次要结局
- Japanese encephalitis virus neutralizing antibody titers(2 years)
研究者
研究点 (2)
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