NCT04839757 Dengue Vaccine Strategy in Children Aged 9 to 17 Years in the French Caribbean
| NCT ID | NCT04839757 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Center of Martinique |
| Condition | Dengue |
| Study Type | OBSERVATIONAL |
| Enrollment | 590 participants |
| Start Date | 2021-06-03 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 590 participants in total. It began in 2021-06-03 with a primary completion date of 2025-12.
⚠ 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
Dengue fever, an arbovirus transmitted by the Aedes mosquito, is a public health problem in all tropical and subtropical regions of the world. There is currently no antiviral treatment and vector control has shown its limits. The 2018 European marketing authorization of the tetravalent chimeric yellow fever / dengue vaccine (Dengvaxia®) is a major step forward in the fight against the disease. Dengvaxia® is indicated for the prevention of dengue due to serotypes DENV 1-4 in subjects aged 9 to 45 years with a history of infection with the dengue virus and living in endemic areas (seroprevalence of at least 70% in the target population). Dengue seroprevalence data in the French Caribbean territories of Martinique and Guadeloupe dates back to 2011 and concerns only adult blood donors aged 18 to 70 years. To date, no data exists for individuals aged 9 to 17 years in the region. In order to implement an optimal vaccine introduction strategy for these territories, the main aim of the DengueSEA study is to estimate the seroprevalence of the Dengue viruses (DENV 1-4) in 9-17 year olds giving a blood sample as part of care in hospital departments of the French Caribbean islands of Martinique and Guadeloupe.
Eligibility Criteria
CHILDREN Inclusion Criteria for children: * Any child aged 9 to 17 years presenting to one of the hospital departments participating in the study at the University Hospitals of Martinique or Guadeloupe * Need to take a blood sample or place a peripheral venous line for the management of the child * Residence in Martinique or Guadeloupe since at least one year * Information on the study given to the child and his/her parent or legal guardian * Collection of the parent's or legal guardian's non-objection to the child's participation Exclusion Criteria for children: * Presence of fever or suspected acute infection * Presence of an immune deficiency or any other dysimmune condition PARENTS Parental inclusion criteria ("vaccine acceptability" survey) * Collection of the parent's or legal guardian's non-objection to participate in the Dengvaxia® vaccine acceptability survey * Comprehension of spoken and written French Non-inclusion criteria for parents (vaccine acceptability survey) \- None of the above
Contact & Investigator
Andre CABIE
PRINCIPAL INVESTIGATOR
Martinique University Hospital Center
Frequently Asked Questions
Who can join the NCT04839757 clinical trial?
This trial is open to participants of all sexes, aged 9 Years or older, up to 17 Years, studying Dengue. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04839757 currently recruiting?
Yes, NCT04839757 is actively recruiting participants. Contact the research team at veronique.pelonde-erimee@chu-martinique.fr for enrollment information.
Where is the NCT04839757 trial being conducted?
This trial is being conducted at Fort-de-France, Martinique.
Who is sponsoring the NCT04839757 clinical trial?
NCT04839757 is sponsored by University Hospital Center of Martinique. The principal investigator is Andre CABIE at Martinique University Hospital Center. The trial plans to enroll 590 participants.