Real-world Effectiveness, Safety and Immunogenicity of Chikungunya Vaccination in Populations at Risk of Severe or Complicated Forms: Prospective Study in La Réunion
NCT06928753 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1800
Last updated 2025-07-29
Summary
Against the backdrop of a growing chikungunya epidemic in La Réunion, this prospective study will assess the real-life efficacy, safety and immunogenicity of IXCHIQ® vaccine in vulnerable individuals (seniors, comorbid patients), defined by the French Health Autority (HAS) as at risk of severe or complicated forms and/or chronic disabling forms (chronic arthritis, chronic fatigue phenotypes). This study will also provide input for the preparation of a cluster randomized trial on a population scale.
Conditions
- Chikungunya Virus Infection
Interventions
- BIOLOGICAL
-
IXCHIQ
Group of vaccinated arm will be with the IXCHIQ vaccine
Sponsors & Collaborators
-
ANRS, Emerging Infectious Diseases
collaborator OTHER_GOV -
Région La Réunion
collaborator UNKNOWN -
ARS La Réunion
collaborator UNKNOWN -
Direction Générale de l'offre de Soins (DGOS)
collaborator UNKNOWN -
Centre Hospitalier Universitaire de la Réunion
lead OTHER
Principal Investigators
-
Patrick GERARDIN, MD · CHU La Réunion
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-18
- Primary Completion
- 2026-04-30
- Completion
- 2026-10-31
Countries
- France
Study Locations
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