Dengue vaccine shows promise in massive child trial
NCT ID NCT02747927
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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20,099 people
The number who actually took part.
- Started
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Apr 2016
- Finished
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Jun 2024
- Lead sponsor
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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
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4 to 16 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Associacao Obras Sociais Irma Dulce Hospital Santo Antonio
Salvador, Estado de Bahia, 40415-000, Brazil
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Calle Alexander Fleming No. 90 Esquina 37, Ensanche La Fe
Santo Domingo, Distrito Nacional Santo Domingo, 10514, Dominican Republic
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Centro De Vacunacion Internacional, S.A. (Cevaxin)
Panama City, 10662, Panama
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Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede 24 de Diciembre
Panama City, Panama
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Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede Plaza Carolina
Panama City, Panama
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Centro De Vacunacion Internacional, S.A.(Cevaxin) - La Chorrera
Panama City, Panama
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Centro de Atencion e Investigacion Medica S.A - CAIMED - Aguazul - PPDS-PV
Aguazul, Casanare Department, Colombia
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Centro de Atencion e Investigacion Medica S.A - CAIMED - Yopal - PPDS-PV
Yopal, Casanare Department, Colombia
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Centro de Atencion e Investigacion Medica S.A. - CAIMED - Acacias - PPDS-PV
Acacías, Meta Department, 507001, Colombia
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Centro de Estudios em Infectologia Pediatrica SAS (CEIP S.A.S)
Cali, San Fernando, Colombia
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Centro de Estudos e Pesquisa em Molestias Infecciosas LTDA (CPCLIN)
Cidade Alta, Natal - RN, 59025-050, Brazil
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Colombo North Teaching Hospital
Ragama, 11010, Sri Lanka
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Colombo South Teaching Hospital
Dehiwala, 10250, Sri Lanka
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Dela Salle Health Sciences Institute
Dasmariñas, Cavite, 4114, Philippines
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Hospital Maternidad Nuestra Senora de Altagracia
Santo Domingo, Distrito Nacional Santo Domingo, 10204, Dominican Republic
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Lady Ridgeway Hospital for Children
Colombo, 00800, Sri Lanka
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Las Pinas Health Center A
Las Piñas, Philippines
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Las Pinas Health Center D
Las Piñas, Philippines
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Negombo General Hospital
Negombo, 11500, Sri Lanka
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Philippines-AFRIMS Virology Research Unit
Cebu City, Cebu, 6000, Philippines
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Phramongkutklao Hospital
Bangkok, Bangkok, 10400, Thailand
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Research Institute for Tropical Medicine
City of Muntinlupa, 1781, Philippines
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Srinagarind Hospital
Khon Kaen, 40002, Thailand
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The Hospital for Tropical Diseases
Bangkok, Bangkok, 10270, Thailand
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Universidad Nacional Autonoma de Nicaragua
León, Nicaragua
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Universidade Federal Do Espirito Santo Hospital Universitario Cassiano Antonio de Moraes HUCAM
Vitória, Espírito Santo, 29040-091, Brazil
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Universidade Federal de Mato Grosso do Sul
Campo Grande, Mato Grosso do Sul, 79070-900, Brazil
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University of the Philippine Manila
Ermita, 1000, Philippines
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