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Recruiting NCT06928753

Real-world Effectiveness, Safety and Immunogenicity of Chikungunya Vaccination in Populations at Risk of Severe or Complicated Forms: Prospective Study in La Réunion

Phase IV Interventional Chikungunya Virus Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IXCHIQ.
Who it may be relevant to
Registry conditions: Chikungunya Virus Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Biological IXCHIQ
    Group of vaccinated arm will be with the IXCHIQ vaccine

Primary outcome measures

  • To measure the vaccine effectiveness at 6 months [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Eligible for anti-chikungunya vaccination according to french Health Authority (HAS)
  • Beneficiary of social security coverage
  • Signature of informed consent form

Exclusion criteria

  • Pregnant women
  • Vaccine 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU La Réunion — Saint-Denis

Identifiers

NCT: NCT06928753 · 2025/CHU/12 · 2025-521307-43-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗