Pneumococcal diseases
Conditions
Interventions
Elevenvalent Conjugate Vaccine against Pneumococci (PCV11) (Experimental group): The vaccine will be administered by intramuscular route on the anterolateral aspect of the left thigh. Primary vaccinat
Sponsors
Finlay Vaccine Institute (FVI)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Infants two months of age, of both sexes, whose parents or legal guardians sign the informed consent. 2. Weight-height nutritional assessment above the 10th percentile. 3. Birth weight greater than or equal to 2500 grams. 4. Apgar equal to or greater than 7 at birth and equal to or greater than 8 at five minutes after birth. 5. Maternal gestational age equal to or greater than 37 weeks at the time of delivery.
Exclusion criteria
Exclusion criteria: 1. Acute infectious disease at the time or within 7 days before the application of each dose. (You can wait up to 14 days after the date on which the second dose and booster dose vaccination is due). 2. Use of any investigational product. 3. Present a history of immunosuppressive or immunostimulant treatment in the 30 days prior to the administration of the vaccine. 4. History of treatment with blood products such as transfusions of blood cells, plasma, whole blood, platelet concentrate, gamma globulins and transfer factor at some point in their life. 5. History of anaphylaxis after the administration of a vaccine, mercurial products such as Thiomersal or other drugs. 6. History of severe allergic reactions or diseases. 7. History of immunosuppressive disease, congenital or acquired. 8. Infants with a history of febrile seizure illness. 9. Major congenital diseases or malformations. 10 Infants with a history of recurrent or chronic diseases such as bronchial asthma, diabetes mellitus, epilepsy, atopic or allergic dermatitis or eczema, immunosuppressed, encephalopathies). 11. History of application of any vaccine against Streptococcus pneumoniae. 12. Infants with a history of receiving any vaccine from the Cuban vaccination scheme in a period of less than 15 days, prior to the administration of the investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Seroprotection (It is defined as concentration of anti-PsC IgG antibodies = 0.35 µg/mL [= 0.35 /< 0.35]). Measurement time: Four weeks after second dose and, four weeks after booster dose. 2. Adverse Events-AE (Type of AE (Description of the AE), Severity of the AE (Grievous/Serious; Not grievous/Not serious), Intensity of the AE (Mild, Moderate, Severe), Causality of the AE (A. Causal association consistent with immunization [A1. Event related to the vaccine product; A2. Event related to a vaccine quality defect; A3. Event related to immunization errors; A4. Event related with immunization anxiety]; B. Undetermined [B1. The temporal relationship is consistent, but there is insufficient definitive evidence that the vaccine caused the event; B2. Review of factors results in conflicting trends of consistency - inconsistency of causal association with immunization]; C. Inconsistent causal association with immunization; D. Not classifiable)). Measurement time: until four weeks after booster dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Antibody concentration (Concentration of anti-Psc IgG antibodies [ug/ml]). Measurement time: Four weeks after second dose and, four weeks after booster dose. 2. Opsonophagocytic titers (Functionality of the antibodies determined through opsonophagocytic titers in a subsample of 20% of the included participants; titers = 1:8 will be considered protection according to the correlation of protection established by the WHO). Measurement time: Four weeks after booster dose. 3. Opsonophagocytic titers = 1:8 (Opsonophagocytic titers = 1:8/Opsonophagocytic titers < 1:8). Measurement time: Four weeks after booster dose. | — |
Countries
Cuba
Contacts
Public ContactNarciso Jimenez Perez
Finlay Vaccine Institute (FVI)
Outcome results
None listed