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

INTERVENTION: Group I (study): Received the combined DPT‐HB‐Hib vaccine (liquid). 0.5 mL. Group II (control): Received the commercial combined DPT‐HB+Hib vaccine (Heberpenta). 0.74 mL. Both groups received the vaccine by intramuscular route, with a schedule of 2‐4‐6 months CONDITION: Prophylaxis against infections diseases: Diphtheria, Tetanus, B. pertussis, H. influenzae type b and hepatitis B. PRIMARY OUTCOME: 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: 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 ug/mL and = 1.0 ug/mL long term protection. 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.