RPCEC00000103
Completed
Phase 1
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 sites624 target enrollmentApril 29, 2011
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prophylaxis against infections diseases: Diphtheria, Tetanus, B. pertussis, H. influenzae type b and hepatitis B.
- Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB).
- Enrollment
- 624
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Not specified
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