About us
It is a synergistic organizational structure that articulates functionally and contractually, intra and inter-business / institutional relations, in order to respond jointly and flexibly, under the direction of the Finlay Vaccine Institute, to the demand for clinical research, epidemiological studies and pharmacovigilance, as well as the evaluation of effectiveness and social and health impact related to its products and technologies in favor of a scientifically supported technical-managerial decision making.
Mission
The Directorate of Clinical Research and Impact Evaluation of the Finlay Institute is responsible for designing and implementing clinical research, surveillance studies, evidence analysis and studies evaluating social and health impact of its products and technologies to contribute effectively, efficiently and with high quality standards to scientifically supported decision making.
Vision
The Directorate of Clinical Research and Impact Evaluation of the Finlay Institute will be recognized as a specialized leader in clinical research, epidemiological and evaluation studies and the synthesis and analysis of evidence related to its products and technologies.
Vaccine Candidates
Pneumococcal (PCV7-TT)
Vaccine Candidates have the following Studies:Evaluation of effectiveness and impact
2016
In preparation
Type of study
Community Intervention Trial
Objective
Evolution of the direct effects in vaccinated and indirect in cohabiting and the population impact on colonization and diseases associated with pneumococcus.
Population
Children 1-5 years old and living together
Sample (n)
12300
Site
Health Areas (APS) of Cienfuegos province
Researchers / Collaborators
Pharmacovigilance
2017-2020
In preparation
Type of study
Pharmacovigilance
Objective
ESAVI surveillance
Population
Pediatric age with emphasis on children under 5 years old
Sample (n)
All cases hospitalized and treated in the PHC
Site
HPGC (Cienfuegos), HPIS y HPIN (Santiago de Cuba), HJMM, HPWS, HPCH (La Habana).
Researchers / Collaborators
Pneumococcal diseases
2014-2018
In progress
Type of study
Sentinel Surveillance Study
Objective
Clinical characterization of cases, circulation of serotypes and hospital burden of disease
Population
Pediatric age with emphasis on children under 5 years old
Sample (n)
All hospitalized cases
Site
HPGC (Cienfuegos), HPIS y HPIN (Santiago de Cuba), HJMM, HPWS, HPCH (La Habana)
Researchers / Collaborators
Colonization
2016
Not started
Type of study
Descriptive cross-sectional observational
Objective
Prevalence of global colonization and serotypes in children 1-5 years old and living in Santiago de Cuba
Population
1-5 year old children and co-survivors belonging to irrigation groups
Sample (n)
570 households - children 1-5 years
Site
6 Health Areas (PHA) of the municipality of Santiago de Cuba
Researchers / Collaborators
2015-2016
In progress
Type of study
Observational analytical monitoring
Objective
Frequency of illness, hospitalization and changes in colonization one year after vaccination.
Population
1-5 year old children vaccinated
Sample (n)
570 children 1-5 years vaccinated
Site
8 Health Areas (PHA) of the Cienfuegos municipality
Researchers / Collaborators
2014
Concluded
Type of study
Descriptive cross-sectional observational
Objective
Prevalence of global colonization and serotypes
Population
Children, 3-18 months
Sample (n)
978
Site
Health Areas (PHA) Cienfuegos
Researchers / Collaborators
Clinical evaluation
2016
Not started
Type of study
EC Phase I-II
Objective
Safety (reactogenicity) Immunogenicity, not inferiority, comparison of schemes and booster effect
Population
2-4 months
Sample (n)
520, (120 phase I y 300 phase II)
Site
HJMM La Habana y HPPG Cienfuegos Áreas de Salud (APS) de Cienfuegos y La Habana
Researchers / Collaborators
2014-2015
In progress
Type of study
EC Phase II-III
Objective
Immunogenicity, not inferiority
Population
Preschoolers 12-23 months and 2-5 years
Sample (n)
1135
Site
Health Areas (PHA) Cienfuegos
Researchers / Collaborators
2013-2014
Concluded
Type of study
EC Phase I
Objective
Safety (reactogenicity) and immunogenicity scan
Population
Preschoolers, 4-5 years and Infants, 7-11 months
Sample (n)
45
Site
HJMM
Investigadores/Colaboradores
2012
Concluded
Type of study
EC Phase I
Objective
Safety (reactogenicity)
Population
Adults, 18-35 años
Sample (n)
20
Site
CENATOX