Pneumococcal disease
Conditions
Interventions
Group 1 (Experimental). Intervention 2p + 1, VCN7-T with outdated VA-MENGO-BC® vaccine, 2 doses of VCN7-T with an 8-week interval, by intramuscular route on the anterolateral left thigh, administered
Vaccines, Conjugate
Vacuna Va-Mengoc-BC®
Heberpenta®
Prevnar13®
VCN7-T
Sponsors
Finlay Institute Vaccine
Eligibility
Sex/Gender
All
Age
2 Months to 3 Months
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria: 1. Infectious diseases at moment of vaccination or 7 days before vaccination. 2. Previous use of any investigation product or any product 30 days before vaccination. 3. History of immune suppressor or immune stimulant treatment 30 days before vaccination. 4. History of use of blood products like blood transfusions, plasma, whole blood, platelet concentrate, gamma globulins and transfer factor at any time of lives. 5. History of anaphylaxis reactions related with the use Thiomersal or other pharmaceutical products. 6. History of severe allergic diseases or reactions. 7. History of immunosuppressive, congenital or acquired disease. 8. Infants with febrile convulsions history. 9. Diseases or mayor genetic defects. 10. History of chronic diseases as Asthma Bronquial, Diabetes Mellitus, Epilepsy, Allergic Dermatitis, encephalopathy and others. 11. Immunization with any Streptococcus pneumoniae vaccine. 12. History of vaccination with any vaccine 15 days before the administration of research product. 13. Mother less than 18 years old or mental disability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - 48 - 24 - 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® (Continuous. From the quantification limit (0.15 µg / mL) to the maximum concentration Quantified by the method (ELISA). Subjects reaching concentration = 0.35 µg / 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® (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
| Measure | Time frame |
|---|---|
| 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 . | — |
Countries
Cuba
Contacts
Public ContactNivaldo Linares Perez
Finlay Institute
Outcome results
None listed