Reactogenicity and Immunogenicity of the pentavalent vaccine DPT-HB+Hib. Schedule 2-4-6 months.

Phase 1

Conditions: Prophylaxis against infections diseases: Diphtheria, Tetanus, B. pertussis, H. influenzae type b and hepatitis B.

Registration Number: RPCEC00000103

Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB).

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 624

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: Measuring time: 1 hour, 24, 48 and 72 hours and 7 and 30 days after each dose. Measured as: Local Events (Erythema, Induration, Pain, Infiltration, abscess) and Sistemic Events (Fever, feverish, irritability, vomits, persistent crying, anaphylactic shock).

Secondary Outcome Measures

Name	Time	Method
Immunogenicity: Measuring time: 30 days after the 3rd dose (last dose). Measured as: Anti-HBsAg titres = 10 IU/L, and % of hyper-response (anti-HBsAg titres = 100 IU/L). Titres against the diphtheria and tetanic toxoids = 0.1 IU/mL, Titres anti-B. pertussis specific = 11 UN (Novatec Units) to the value of cut of the determination. Titres anti-PRP of Hib = 0.15 µg/mL and = 1.0 µg/mL long term protection.