RPCEC00000135尚未招募2 期
Immunogenicity, tolerance and reactogenicity of Quimi-Hib and alum phospate adjuvanted Quimi-Hib vaccines in healthy infants according to 6 – 10 – 14 weeks primary vaccination series. A multicenter, controlled, randomized, doubled blind clinical trial.”
Center for Genetic Engineering and Biotechnology0 个研究点目标入组 208 人开始时间: 2012年9月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 208
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Parallel. Purpose: Prevention
入排标准
- 年龄范围
- aged 6 weeks 至 7 weeks（—）
- 性别
- All
入选标准
- •1.Signing of the written inform consent Act by parents/legal guardians. 2.6 weeks old healthy infants, both sexes, with normal clinical examination and medical history. 3.Nutritional evaluation over 10 percentile 4.History of no primary immunization series against Hib or DTP. 5.Administration of the scheduled Hepatitis B vaccine dose at birth
排除标准
- •1.Administration of other Investigation Medicinal Product (IMP) different to IMP under study in the 30 days previous to administration of the 1st vaccine dose or its intention of use during the period planned for the clinical trial. 2.Acute infectious illness or body temperature over 37?C at the moment of vaccination visit. 3.History of preterm delivery (birth before 36th weeks of pregnancy). 4.Major congenital defects or serious chronic disease. 5.Infants with history of convulsive or non-convulsive encephalopathy. 6.Chronic medication (defined as more than 21 days of treatment) with immune-suppressor or immuno-modulatory drugs prior to administration of the 1st vaccine dose. 7.History of invasive Hib disease. 8.Any suspected or diagnosed immune-suppression or immunodeficiency (congenital o secondary), including HIV infection, based on the medical history and physical examination. 9.History of allergic reactions or allergic disease with probability to be exacerbated by any component of the vaccine under study (including thiomersal allergy). 10.Gammaglobulin administration or other blood –derived components during the period prior to administration of the 1st vaccine dose or the intention of administration during the planned trial period. 11.Maternal history for HIV or HBV infection, based on the medical records.
研究者
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