Effectiveness of Dengue Vaccine in Children and Adolescents

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

This study is testing how well a new dengue vaccine works to keep children and teens in Southeast Asia out of the hospital due to dengue fever.

Quick facts

• Study type: Observational
• Enrollment: 70000 (estimated)
• Ages: 6 Years to 12 Years
• Sex: All
• Sponsor: Takeda (Industry-sponsored)
• Locations: 7 sites (Banjarmasin, South Kalimantan and 6 other locations)
• Trial ID: NCT06843226 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather data on the effectiveness of Takeda's Dengue Tetravalent Vaccine (TDV) in reducing hospitalizations due to dengue fever among children and adolescents in Southeast Asia. Participants will be part of a community-based cohort, with individual follow-up lasting three years. The study will compare hospitalization rates between those vaccinated with TDV and those who are not, while also assessing the vaccine's effectiveness against less common dengue virus serotypes. The findings will contribute to understanding the vaccine's impact in real-world settings.

Who should consider this trial

Good fit: Ideal candidates for this study are children and adolescents eligible for vaccination with TDV in the designated Southeast Asian regions.

Not a fit: Patients who are not eligible for the TDV vaccination or who plan to migrate away from the study area within three years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could demonstrate the effectiveness of the TDV in significantly reducing hospitalizations due to dengue fever in children and adolescents.

How similar studies have performed: Other studies have shown promising results with similar dengue vaccination approaches, indicating potential for success in this observational study.

Eligibility criteria

Inclusion Criteria:

Cohort:

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

1. The participant is a child or adolescent eligible to be vaccinated with TDV as part of a vaccination program planned in the study area.
2. 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.
3. 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.
4. 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.
5. 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:

1. The participant is part of the cohort.
2. The participant is hospitalized and clinically diagnosed with dengue.
3. 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.
4. 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:

1. The participant is part of the cohort.
2. 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).
3. The participant is a resident in the same neighbourhood as the matched case.
4. The participant's date of birth is in the same calendar year as the matched case.

Exclusion Criteria

Cases:

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

1. 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.
2. 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:

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

Where this trial is running

Banjarmasin, South Kalimantan and 6 other locations

• Fakultas Kedokteran Lambung Mangkurat — Banjarmasin, South Kalimantan, Indonesia (Recruiting)
• Fakultas Kedokteran Universitas Sriwijaya — Palembang, South Sumatra, Indonesia (Recruiting)
• Fakultas Kedokteran Universitas Indonesia — Jakarta Pusat, Indonesia (Recruiting)
• Universiti Malaya Medical Centre — Kuala Lumpur, Malaysia (Not_yet_recruiting)
• Pattaya Patamakhun Hospital — Chon Buri, Thailand (Active_not_recruiting)
• Nakhon Phanom Hospital — Nakhon Phanom, Thailand (Active_not_recruiting)
• Phra Nakhon Si Ayutthaya Hospital — Phra Nakhon Si Ayutthaya, Thailand (Active_not_recruiting)

Study contacts

• Study coordinator: Takeda Contact

Conditions Dengue Fever; Dengue Tetravalent Vaccine