Infectious disease: Chikungunya
Conditions
Brief summary
EV defined as the quotient of the difference in attack rate between unvaccinated and vaccinated participants divided by the attack rate in unvaccinated participants: EV (%): (λnv - λv) × 100 / λnv The attack rate (λ) corresponds to the cumulative incidence (%) at the end of the study follow-up period (interim analysis at 3 months at the end of the hot season, then at the end of full follow-up at 12 months) from D7 post-vaccination for the vaccinated group.
Detailed description
Rate of hospitalization over 24 hours and preventive fraction of hospitalization in vaccinated and unvaccinated participants, Rate of ICU hospitalization or death and preventive fraction in vaccinated and unvaccinated participants at D30 and at the end of the study, Rate of disabling complications such as arthralgia and/or chronic phenotypes (fatigue/anxiety-depression) at 3 months of inclusion, and at the end of the study.
Interventions
DRUGIXCHIQ powder and solvent for solution for injection
Chikungunya vaccine (live)
Sponsors
Centre Hospitalier Universitaire De La Reunion
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EV defined as the quotient of the difference in attack rate between unvaccinated and vaccinated participants divided by the attack rate in unvaccinated participants: EV (%): (λnv - λv) × 100 / λnv The attack rate (λ) corresponds to the cumulative incidence (%) at the end of the study follow-up period (interim analysis at 3 months at the end of the hot season, then at the end of full follow-up at 12 months) from D7 post-vaccination for the vaccinated group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of hospitalization over 24 hours and preventive fraction of hospitalization in vaccinated and unvaccinated participants, Rate of ICU hospitalization or death and preventive fraction in vaccinated and unvaccinated participants at D30 and at the end of the study, Rate of disabling complications such as arthralgia and/or chronic phenotypes (fatigue/anxiety-depression) at 3 months of inclusion, and at the end of the study. | — |
Countries
France
Outcome results
None listed