RecruitingNCT06776692

Characterisation of Dengue Vaccine-induced Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination

Characterisation of Dengue Vaccine (Qdenga®, TAK-003)-Induced Humoral and Cellular Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Enrollment

402 participants

Start Date

Jul 10, 2024

Study Type

OBSERVATIONAL

Conditions

Dengue Vaccines

Summary

The goal of this observational study is to learn about the immunity induced by the Qdenga® vaccine in vaccinees. Participants that will receive the Dengue vaccine as part of their routine before a travel will be asked to undergo a blood sample at the time of administration of the first dose (T0), 24-48 hours after the first dose (T1) of the vaccine, immediately before the second dose (T2 ) and one to two months after the second dose (T3). Possibly a further sample will be collected within 2 years.

Eligibility

Min Age: 4 Years

Inclusion Criteria3

Subjects of both sexes presenting to the DITM to receive the anti-DENV vaccine whether or not they have had a history of prior DENV or other flaviviruses infection or a history of prior vaccination against other flaviviruses. These data will be recorded in the study CRF.
Age >= 4 years.
Signed informed consent.

Exclusion Criteria2

Age < 4 years.
Absence of signed informed consent.

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Interventions

DRUGQdenga

Administration of Dengue vaccine and blood sample collection

Locations(1)

IRCCS Sacro Cuore Don Calabria

Negrar, VR, Italy

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NCT06776692