A Study in Children and Teenagers to Learn if a TDV Dengue Vaccination Lowers the Chance of Hospital Stays for Dengue

Официальное название

The Association Between Prior Exposure to Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) and Dengue Hospitalization in a Pediatric and Adolescent Population: A Nested Case-Control Post-Authorization Effectiveness Study

Обзор

The main aim of this study is to collect more information on the effectiveness of TDV when used in a pilot public vaccination program for children and adolescents participating in a community-based cohort in Southeast Asian countries with high dengue transmission, specifically Thailand, Indonesia, and Malaysia where TDV is already approved for use. The study will include cohort participants (individual follow-up of 3 years) who may or may not later be vaccinated with TDV as part of a pilot public vaccination program in the study countries. The study will investigate if cohort participants who were vaccinated with TDV have less hospital stays due to dengue than cohort participants who were not vaccinated with TDV. The study will also provide further information on the effectiveness of TDV against the least common dengue virus serotypes (DENV-3 and DENV-4).

Вмешательства

• Другое No Intervention
  This is a non-interventional study.

Первичные конечные точки

• Hospitalization Due to VCD of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants [Срок оценки: Up to Month 36]

Вторичные конечные точки (3)

• Hospitalization Due to VCD By Each Infecting Dengue Serotype (DENV-1, DENV-2, DENV-3, DENV-4) in Unvaccinated and Fully Vaccinated Participants [Срок оценки: Up to Month 36]
• Hospitalization Due to VCD by Baseline Dengue Serostatus (Seronegative and Seropositive) of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants [Срок оценки: Up to Month 36]
• Hospitalization Due to VCD By Each Infecting Dengue Serotype and Baseline Dengue Serostatus in Unvaccinated and Fully Vaccinated Participants [Срок оценки: Up to Month 36]

Критерии участия

Критерии включения

Cohort:

To be eligible for inclusion in the study cohort, participants must meet the following inclusion criteria:

• The participant is a child or adolescent eligible to be vaccinated with TDV as part of a vaccination program planned in the study area.
• The participant's family do not intend to migrate away from the cohort hospital catchment area within 3 years of his/her enrollment into the study cohort.
• The participant's parent(s) or legally acceptable representative (LAR) signs and dates a written informed consent form (ICF), and any required privacy authorization where applicable, prior to the initiation of any study procedures, after the nature of the study has been explained according to local regulatory requirements.
• The participant signs and dates an age-appropriate assent form prior to the initiation of any study procedures, after the nature of the study has been explained according to local regulatory requirements.
• The participant's parent(s) or LAR agrees that a baseline blood sample may be taken from the participant.

Cases:

To be eligible for inclusion as a case, participants must meet the following inclusion criteria:

• The participant is part of the cohort.
• The participant is hospitalized and clinically diagnosed with dengue.
• The participant has a blood sample available that was taken preferably within 5 days of fever onset and/or onset of symptoms compatible with dengue.
• The participant tested positive for dengue by RT-PCR.

Controls:

To be eligible for inclusion as a matched control, participants must meet the following inclusion criteria:

• The participant is part of the cohort.
• The participant had not been hospitalized with VCD at any point between enrollment in the cohort and the index date (that is, when his/her matched case was hospitalized with CDD).
• The participant is a resident in the same neighbourhood as the matched case.
• The participant's date of birth is in the same calendar year as the matched case.

Критерии исключения

Cases:

To be eligible for inclusion as a case participants must not meet any of the following criteria:

• The participant has been vaccinated with TDV, a tetravalent, live attenuated, chimeric dengue vaccine in a yellow fever 17D backbone (CYD-TDV), or an investigational dengue vaccine prior to cohort enrollment.
• Contraindications as per the locally approved label/product information leaflet.

Controls:

To be eligible for inclusion as a control participants must not meet any of the following criteria:

• The participant has been vaccinated with TDV, CYD-TDV, or an investigational dengue vaccine prior to cohort enrollment.
• Contraindications as per the locally approved label/product information leaflet.
• The participant could not be contacted at the time of being selected as a control.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Индонезия · 3 центра

• Fakultas Kedokteran Lambung Mangkurat — Banjarmasin
• Fakultas Kedokteran Universitas Sriwijaya — Palembang
• Fakultas Kedokteran Universitas Indonesia — Jakarta Pusat

Таиланд · 3 центра

• Pattaya Patamakhun Hospital — Chon Buri
• Nakhon Phanom Hospital — Nakhon Phanom
• Phra Nakhon Si Ayutthaya Hospital — Phra Nakhon Si Ayutthaya

Малайзия · 1 центр

• Universiti Malaya Medical Centre — Kuala Lumpur

Идентификаторы

NCT: NCT06843226 · DEN-401 · EUPAS1000000218

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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