Evaluation of the safety and immunogenicity of the combined pentavalent vaccine DPT-HB-Hib, liquid, in healthy suckling children according to a schedule of administration at 2-4-6 months of age. Comparative, open and randomized clinical trial.

Center for Genetic Engineering and Biotechnology (CIGB).0 个研究点目标入组 624 人开始时间: 2011年4月29日最近更新: 2024年8月19日

适应症

试验速览

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研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Prevention

年龄范围: Suckling children of 6 week at moment of 1st dose. 至 Suckling children of 10 week at moment of 1st dose（—）
性别: All

•Newborns on term of any sex, healthy, with normal history and clinical exam. Participating in a voluntary way (signing of the Informed Consent by the parents). Nutritional evaluation over the tenth percent (p10), so when born (weigh > 2500 gr ). Children from mothers with absence of surface antigen against the virus of hepatitis B during pregnancy. Not having received vaccines against Tetanus, Diphtheria, Whooping Cough, Hepatitis B or Haemophilus influenza previously to the initiation of the study or beyond the study, once initiated this.

•Presenting, when born, a diagnosis of any of the following conditions: congenital irregularity, endocrine-metabolic disease, convulsive encephalopathy, chronic disease involving the liver or the hemolymphopoietic, respiratory, or urogenital systems, etc. If the family plans to change home or move out of the locality during the period of duration of the study. Icteric disease of any origin (except physiological icterus) or acute hepatic disease. Allergy to any of the components of the vaccine (for instance, Tiomersal).

发起方

Center for Genetic Engineering and Biotechnology (CIGB).