Heptavalent Conjugate Vaccine against Pneumococcal (VCN7-T) in healthy children.

INTERVENTION: First Stage: Children 2 to 5 years. Study Group (Heptavalent Pneumococcal Conjugate Vaccine (VCN7‐T)): 1 dose of VCN7‐T, intramuscularly in the deltoid. Control Group (Pneumococcal 10‐valent protein D conjugate Haemophilus influenzae nontypable, Synflorix (R), GlaxoSmithKline): 1 dose of Synflorix, intramuscularly in the left deltoid. Second stage: Children 12 to 23 months. Study Group (Heptavalent Pneumococcal Conjugate Vaccine (VCN7‐T)): 2 doses of VCN7‐T with interval of 8 weeks intramuscularly in the deltoid. Control Group (Pneumococcal 10‐valent protein D conjugate Haemophilus influenzae nontypable, Synflorix (R), GlaxoSmithKline): 2 doses of Synflorix with interval of 8 weeks intramuscularly in the deltoid. CONDITION: Pneumococcal infection PRIMARY OUTCOME: ‐ Geometric mean concentration of anti‐PsC antibodies for each serotype included in VCN7‐T and additional serotypes 6A and 19A (continuous). Measurement time: First stage: Before and 30 days post‐vaccination, Second Stage: Before the first dose and 30 days after the second dose. ‐ Seroprotection (dichotomous): Proportion of subjects reaching anti‐PsC concentration of antibodies for each serotype included in VCN7‐T and additional serotypes 6A and 19A of >= 0.20 mg / mL. Measurement time: First stage: Before and 30 days post‐vaccination, Second Stage: Before the first dose and 30 days after the second dose. ‐ Seroconversion (dichotomous): proportion of subjects who seroconverted. Measurement time: First stage: Before and 30 days post‐vaccination, Second Stage: Before the first dose and 30 days after the second dose. SECONDARY OUTCOME: Adverse event (AE). Measuring time: 3 hours after each immunization and at 24, 48, 72 hours, 7, 21 and 30 days. ‐Description of the expected AE (Fever, pain injection site, erythema, induration, local temperature increase, functional impotence, infiltration, abscess, necrosis, headache, malaise, nausea, vomiting, weakness, anaphylactic shock. ‐Description of the unexpected AE (Any signs or symptoms that appear after the before vaccination and 30 days is not expected within the AE. ‐Duration of AE (<= 24 hours> 24 ‐ <= 48 hours> 48 ‐ <= 72 hours, more than 72 hours). ‐Emergence of AE (<= 24 hours> 24 ‐ <= 48 hours> 48 ‐ <= 72 hours, more than 72 hours). ‐Intensity of AE (mild, moderate, severe). ‐Severity of AE (Grave / Serious, not serious). ‐Results of AE (recovered, recovered with sequelae, persistence, death or unknowns). ‐Causality relationship (very likely or certain, probable, possible, unlikely, not related, not classifiable). INCLUSION CRITERIA: 1. Children 2‐5 years old in the first stage and 12 to 23 months in the second, residents in municipality Cienfuegos, whose health condition, established by medical criteria, by physical examination, medical history and personal and family history. 2. Children whose parents or guardians sign the Informed Consent. 3. Nutritional assessment greater than the 3rd percentile.