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NCT06928753
Real-world Effectiveness, Safety & Immunogenicity of Chikungunya Vaccination: Ambispective Study in Reunion & French Guiana
Conditions: Chikungunya Virus Infection
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 1505
Sponsor: Centre Hospitalier Universitaire de la Réunion
Location: Centre Hospitalier Universitaire de Guyane Cayenne
Summary
In the context of the ongoing chikungunya epidemic in Réunion Island and the anticipated epidemic in French Guiana, we propose an ambispective study to evaluate the real-world effectiveness, safety, and immunogenicity of the recommended vaccines, IXCHIQ® and VIMKUNYA®, as defined by the French National Authority for Health (HAS).
Eligibility Criteria
Inclusion Criteria:
Retrospective study VIMKUNYA or IXCHIQ
* Adult (Aged 18 or above)
* Adult (Aged 18 or above) eligible for anti-chikungunya vaccination according to French High Health Authority (HAS)
Prospective study
* VIMKUNYA: Adult (Aged 18 or above) eligible for anti-chikungunya vaccination according to French High Health Authority (HAS)
* IXCHIQ: Adult (Aged 18 -64) eligible for anti-chikungunya vaccination according to French High Health Authority (HAS) Eligibility Criteria common to both groups
* Agreeing to participate in study
* Beneficiary of French social security coverage
* Signature of informed consent form
Exclusion Criteria:
* Pregnant or breastfeeding women entering the prospective study
* Vaccine (IXCHIQ or VIMKUNYA) contraindication for patients undergoing medical treatment
* Persons under guardianship, curatorship or safeguard of justice
* Anyone who has received immunoglobulin or a blood or plasma transfusion 3 months prior to vaccine administration
* Missing French Social security coverage
Source: ClinicalTrials.gov (NCT06928753). StuddyBuddy aggregates publicly available trial information.