NCT06928753 Real-world Effectiveness, Safety & Immunogenicity of Chikungunya Vaccination: Ambispective Study in Reunion & French Guiana
| NCT ID | NCT06928753 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Centre Hospitalier Universitaire de la Réunion |
| Condition | Chikungunya Virus Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,505 participants |
| Start Date | 2025-04-18 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,505 participants in total. It began in 2025-04-18 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In the context of the ongoing chikungunya epidemic in Réunion Island and the anticipated epidemic in French Guiana, the investigators 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
Contact & Investigator
Patrick GERARDIN, MD
STUDY DIRECTOR
CHU La Réunion
Frequently Asked Questions
Who can join the NCT06928753 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chikungunya Virus Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06928753 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06928753 currently recruiting?
Yes, NCT06928753 is actively recruiting participants. Contact the research team at patrick.gerardin@chu-reunion.fr for enrollment information.
Where is the NCT06928753 trial being conducted?
This trial is being conducted at Cayenne, French Guiana, Saint-Denis, Reunion.
Who is sponsoring the NCT06928753 clinical trial?
NCT06928753 is sponsored by Centre Hospitalier Universitaire de la Réunion. The principal investigator is Patrick GERARDIN, MD at CHU La Réunion. The trial plans to enroll 1,505 participants.