Effectiveness of Dengue Vaccine in Children and Adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Resomelagon in Dengue Infection: Safety and Function in Adults

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• Two-dose tetravalent dengue vaccine for infants and toddlers

  This will test whether two doses of a tetravalent dengue vaccine given three months apart are safe and help children aged 6 to under 21 months develop protective immune responses.

  Recruiting Phase 3 Takeda · Barranquilla, Atlántico and 3 other locations · NCT06665035

• Zanamivir treatment for severe dengue symptoms

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• Gut leakage in dengue: is the intestinal barrier affected during infection?

  Researchers are studying whether dengue infection disrupts the gut barrier and if that contributes to severe disease in adults with dengue who are in hospital.

  Recruiting University of Oxford · Chittagong, Chattogram Division · NCT07602920

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.