Pneumococcal infections, invasive pneumococcal disease and related syndromes
Conditions
Interventions
Group I (Intervention):
First moment: application of the seven-valent anti-pneumococcal vaccine candidate (VCN7-T)
2 doses (0.5 ml) for all children in the Cienfuegos province from 12 months to 23 months with 29 days
with an interval of 8 weeks, intramuscular route of administration. One dose (0.5 ml) for all children in the Cienfuegos province from 2 years to 5 years, intramuscular route of administration.
Second
Pneumococcal Vaccines
Injections, Intramuscular
Sponsors
Instituto Finlay de Vacunas (IFV)
Eligibility
Sex/Gender
All
Age
12 Months to 5 Years
Inclusion criteria
Inclusion criteria: 1. Children 1-5 years old residing in the health areas of the Province. 2. Children whose parents sign the informed consent for vaccination and follow-up
Exclusion criteria
Exclusion criteria: 1. Children previously vaccinated with any pneumococcal vaccine or participants in previous studies with the VCN7-T vaccine candidate. 2. Children with decompensated chronic diseases according to clinical criteria. 3. Children with a known allergy to thiomersal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative incidence of disease cases (ENI, pneumonia and bacterial meningitis and Acute Otitis Media). operationalization: proportion of cases (# cases of disease / total population x 1000). Measurement time: one year and 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events supposedly attributable to vaccination (ESAVI) with VCN7-T (ESAVI rate (# of subjects with ESAVI / Total doses administered in the campaign x 1000)). Measurement time: 30 days after each administered dose of VCN7-T. Global antimicrobial resistance due to pneumococcus (Proportion of cases (# cases with antimicrobial resistance / total cases sampled x 100)). Measurement time: one year and 3 years | — |
Countries
Cuba
Contacts
Public ContactBeatriz Paredes-Moreno
Finlay Institute of Vaccines
Outcome results
None listed