Evaluation of the safety and immunogenicity of combined pentavalent vaccine DPT-HB-Hib, liquid, in healthy suckling children according to a schedule of administration at 6-10-14 weeks of age. Open and randomized clinical trial.

Center for Genetic Engineering and Biotechnology (CIGB).0 个研究点目标入组 149 人开始时间: 2011年4月27日最近更新: 2024年8月19日

适应症

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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

•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 ) as when to the suckling child before each dose. 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 or Haemophilus influenzae previously to the initiation of the study or beyond the study, once initiated this.

•Absence of any of the inclusion criteria. Temperature = 37 °C in the moment of the visit for administering the vaccine or within the 24 previous hours having a diagnose of acute infectious disease at the moment of the application of the vaccine or in the three previous days. 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. Background of having received any vaccine against Hepatitis B, DPT or Haemophilus influenzae that is not within those administered in the study. Allergy to any of the components of the vaccine (for instance, Tiomersal). The administration during the assay of any medicament immuno-stimulating or immuno-modulator (cortico-esteroids for more than two weeks, immunoglobulin, etc).

发起方

Center for Genetic Engineering and Biotechnology (CIGB).