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Dengue vaccine shows promise in massive child trial

NCT ID NCT02747927

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new dengue vaccine in over 20,000 healthy children aged 4 to 16 years. The goal was to see if two doses could prevent dengue fever caused by any of the four dengue virus types. The vaccine was given as a shot under the skin and compared to a placebo. Results showed the vaccine reduced the number of dengue cases and hospitalizations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

20,099 people

The number who actually took part.

Started

Apr 2016

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 16 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Is aged 4 to 16 years, inclusive, at the time of randomization. 2. Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the Investigator. 3. The participant and/or the participant's parent/guardian signs and dates an assent/written informed consent form where applicable, and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements. 4. Can comply with trial procedures and are available for the duration of follow-up. Inclusion criteria for Booster Phase: 1. Is included in the per-protocol set (PPS) of the trial. 2. Was aged 4 to 11 years at the time of randomization in the study (Day 1 \[Month 0\]). Exclusion Criteria: 1. Has febrile illness (temperature ≥38°C) or moderate or severe acute illness or infection at the time of randomization. 2. Has history of or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose an additional risk to the participant due to participation in the trial. 3. Has received any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccine within 28 days after Day 1 (Month 0). 4. Has participated in any clinical trial with another investigational product 30 days prior to Day 1 (Month 0) or intent to participate in another clinical trial at any time during the conduct of this trial. 5. Has previously participated in any clinical trial of a dengue candidate vaccine, or previous receipt of a dengue vaccine. 6. Is first degree relative of individuals involved in trial conduct. 7. Females of childbearing potential who are sexually active, and who have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1 (Month 0). 8. Females of childbearing potential who are sexually active, and who refuse to use an acceptable contraceptive method up to 6 weeks post-second vaccination. 9. Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily. 10. Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures. 11. Identified as an employee of the Investigator or trial center, with direct involvement in the proposed trial or other trials under the direction of that Investigator or trial center. Exclusion criteria for Booster Phase: 1. Receipt of any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1b (Month 0b), or planning to receive any vaccine within 28 days after Day 1b (Month 0b). 2. Participation in any clinical trial with another investigational product at any time during participation in this trial or intent to participate in another clinical trial at any time during the conduct of the booster phase of this trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Associacao Obras Sociais Irma Dulce Hospital Santo Antonio

    Salvador, Estado de Bahia, 40415-000, Brazil

  • Calle Alexander Fleming No. 90 Esquina 37, Ensanche La Fe

    Santo Domingo, Distrito Nacional Santo Domingo, 10514, Dominican Republic

  • Centro De Vacunacion Internacional, S.A. (Cevaxin)

    Panama City, 10662, Panama

  • Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede 24 de Diciembre

    Panama City, Panama

  • Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede Plaza Carolina

    Panama City, Panama

  • Centro De Vacunacion Internacional, S.A.(Cevaxin) - La Chorrera

    Panama City, Panama

  • Centro de Atencion e Investigacion Medica S.A - CAIMED - Aguazul - PPDS-PV

    Aguazul, Casanare Department, Colombia

  • Centro de Atencion e Investigacion Medica S.A - CAIMED - Yopal - PPDS-PV

    Yopal, Casanare Department, Colombia

  • Centro de Atencion e Investigacion Medica S.A. - CAIMED - Acacias - PPDS-PV

    Acacías, Meta Department, 507001, Colombia

  • Centro de Estudios em Infectologia Pediatrica SAS (CEIP S.A.S)

    Cali, San Fernando, Colombia

  • Centro de Estudos e Pesquisa em Molestias Infecciosas LTDA (CPCLIN)

    Cidade Alta, Natal - RN, 59025-050, Brazil

  • Colombo North Teaching Hospital

    Ragama, 11010, Sri Lanka

  • Colombo South Teaching Hospital

    Dehiwala, 10250, Sri Lanka

  • Dela Salle Health Sciences Institute

    Dasmariñas, Cavite, 4114, Philippines

  • Hospital Maternidad Nuestra Senora de Altagracia

    Santo Domingo, Distrito Nacional Santo Domingo, 10204, Dominican Republic

  • Lady Ridgeway Hospital for Children

    Colombo, 00800, Sri Lanka

  • Las Pinas Health Center A

    Las Piñas, Philippines

  • Las Pinas Health Center D

    Las Piñas, Philippines

  • Negombo General Hospital

    Negombo, 11500, Sri Lanka

  • Philippines-AFRIMS Virology Research Unit

    Cebu City, Cebu, 6000, Philippines

  • Phramongkutklao Hospital

    Bangkok, Bangkok, 10400, Thailand

  • Research Institute for Tropical Medicine

    City of Muntinlupa, 1781, Philippines

  • Srinagarind Hospital

    Khon Kaen, 40002, Thailand

  • The Hospital for Tropical Diseases

    Bangkok, Bangkok, 10270, Thailand

  • Universidad Nacional Autonoma de Nicaragua

    León, Nicaragua

  • Universidade Federal Do Espirito Santo Hospital Universitario Cassiano Antonio de Moraes HUCAM

    Vitória, Espírito Santo, 29040-091, Brazil

  • Universidade Federal de Mato Grosso do Sul

    Campo Grande, Mato Grosso do Sul, 79070-900, Brazil

  • University of the Philippine Manila

    Ermita, 1000, Philippines

More trials for these conditions

Other studies related to the condition(s) this trial covers.