Safety and immunogenicity of VCN7-T in infants of 2 and 3 months. Phase I/II.

INTERVENTION: Group 1 (Experimental). Intervention 2p + 1, VCN7‐T with outdated VA‐MENGO‐BC(R) vaccine, 2 doses of VCN7‐T with an 8‐week interval, by intramuscular route on the anterolateral left thigh, administered at 3 and 5 months, 1 Dose of VCN7‐T administered at 12 months of age. Group 2 (Experimental). Intervention 2p + 1, VCN7‐T, concomitant with the VA‐MENGO‐BC(R) vaccine, 2 doses of VCN7‐T with an 8‐week interval, by intramuscular route on the anterolateral left thigh, administered at 3 and 5 months, VA‐MENGO‐BC(R) vaccine will be administered concomitantly on the anterolateral aspect of the right thigh, 1 dose of VCN7‐T administered at 12 months of age. Group 3 (Control). Intervention 2p + 1, Prevnar 13 (R) with outdated VA‐MENGO‐BC(R) vaccine, 2 doses of Prevnar 13(R) with an 8‐week interval, by intramuscular route on the anterolateral left thigh, administered at 3 and 5 months, 1 Dose of Prevnar 13 (R) administered at 12 months of age. Group 4 (Control). Intervention 2p + 1, Prevnar 13 (R) with the concomitant VA‐MENGO‐BC(R) vaccine, 2 doses of Prevnar 13(R) with an 8‐week interval, by intramuscular route on the anterolateral left thigh, administered at 3 and 5 months, VA‐MENGO‐BC(R) vaccine will be administered concomitantly on the anterolateral aspect of the right thigh, 1 dose of Prevnar 13 (R) administered at 12 months of age. Group 5 (Experimental). Intervention 3p + 0, VCN7‐T concomitant with Heberpenta(R), 3 doses of VCN7‐T with interval of 8 weeks, by intramuscular route on the anterolateral side of the left thigh, administered at 2, 4 and 6 months. Group 6 (Control). Intervention 3p + 0, Prevnar 13 (R) concomitant with Heberpenta (R), 3 doses of Prevnar 13 (R) with an 8‐week interval, by intramuscular route on the anterolateral side of the left thigh, administered at 2,4 and 6 months Heptavalent Pneumococcal Conjugate Vaccine Vacuna Va‐Mengoc‐BC(R) Heberpenta(R) Prevnar13(R) VCN7‐T CONDITION: Healthy Volunteers Pneumococcal disease PRIMARY OUTCOME: Phase I: Safety Adverse event (AE). Measuring time: 3 hour after each immunization and at 24, 48, 72 hours, 7,15, 21 and 30 days. The AD will be measured like: ‐ Description of the expected AE (Nominal. Any sign or symptom that appears after the vaccination and 30 days before it is declared as AE expected). ‐ Description of the unexpected AE (Nominal. Any signs or symptoms that appear after the before vaccination and 30 days is not expected within the AE). ‐ Duration of AE (Ordinal. <= 24 hours> 24 ‐ <= 48 hours> 48 ‐ <= 72 hours, more than 72 hours) ‐ Emergence of AE (Ordinal. <= 24 hours> 24 ‐ <= 48 hours> 48 ‐ <= 72 hours, more than 72 hours) ‐ Intensity of AE (Ordinal. mild, moderate, severe) ‐ Severity of AE (Nominal. Grave / Serious, not serious) ‐ Results of AE (Nominal. recovered, recovered with sequelae, persistence, death or unknowns). ‐ Causal relationship (Nominal. Causal association consistent with vaccination, Undetermined, Causal association inconsistent) Phase II: Immunogenicity 1. Anti‐PsC antibody concentration of the seven common serotypes between VCN7‐T and Prevnar 13(R) (Continuous. From the quantification limit (0.15 ?g / mL) to the maximum concentration Quantified by the method (ELISA). Subjects reaching concentration >= 0.35 ?g / mL). Measuring time: after the completion of the vaccination . 2. Anti‐Psi antibodies index of the seven common serotypes between VCN7‐T and Prevnar 13(R) (Continuous. From the minimum dilution (1: 4) to the maximum serum dilution causing a 50% death Bacterial (opsonophagocytosis assay). Subjects reaching opsonophagocytic index >= 8). Measuring time: after the completion of the vaccination . SECONDARY OUTCOME: Nasopharyngeal carrier status (nasopharyngeal exudate to explore changes in carrier status and determine circulating serotypes). Measurement time: baseline and, after the completion of the vaccination . INCLUSION CRITERIA: 1. Infants whose parents or legal guardians sign the Informed Consent. 2. Infant of 2 and 3 months of age after questioning and physical examination practiced by the Clinical Investigator. 3. Weight‐height nutritional assessment above the 10th percentile. 4. Birth weight greater than or equal to 2500 grams. 5. Apgar equal or greater than 7 at birth and equal or greater than 8 at five minutes of birth. 6. Maternal gestational age equal to or greater than 37 weeks at the time of delivery.