RPCEC00000101已完成2 期
Reactogenicity and immunogenicity of a new formulation of the cuban conjugated vaccine against Haemophilus influenzae type b (QuimiHib®) adjuvated in aluminium phosphate in healthy infants. A controlled, randomized, doubled blinded clinical trial.”
Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点目标入组 178 人开始时间: 2011年4月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 178
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
- 15 months 至 18 months（—）
- 性别
- All
入选标准
- •1) Voluntary participation (signature of informed consent by parents). 2) Healthy children of both sexes, aged 15-18 months of age, with history and normal clinical examination. 3) Nutritional evaluation over 10 percentile. 4) History of full primary immunization series against Hib (2-4-6 months).
排除标准
- •1) Having received the booster dose against Haemophilus influenzae type b. 2) Submit acute infectious disease at the time of vaccination or within three days prior to the administration of it. 3) Higher temperature at 37oC at the time of the visit to administer the vaccine or from the previous 24 hours. 4) History of chronic diseases eg. Bronchial Asthma, Congenital or acquired Cardiopathies, neuropathies, haematological diseases, etc. 5) Thiomersal allergy or allergy to any components of the vaccine 6) History of convulsive or non-convulsive encephalopathy 7) Underlying immunosuppressive disease, intake of immunosuppressor drugs (including steroids) in the six month period prior to study entry.
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