Dengue Effectiveness Study in the Philippines

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2081 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2023-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is an observational study that aims to determine the effectiveness of a tetravalent dengue vaccine (CYD-TDV) when given through a community-based immunization program against hospitalized and /or severe virologically confirmed dengue.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects

NCT02992418

Dengue Fever Dengue Hemorrhagic Fever

TERMINATED PHASE3

Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose

NCT03999996

Dengue Fever

COMPLETED PHASE3

Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)

NCT04051268

Safety Issues Immunogenicity

COMPLETED PHASE3

Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants

NCT03460405

Safety Issues Immunogenicity

COMPLETED PHASE2

Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III)

NCT04204096

Typhoid

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a matched case-control study. Cases will be children who are admitted with a clinical suspicion of dengue at the study hospitals and were eligible to have received the dengue vaccine during the mass immunization. The outcome of interest is hospitalized and/or severe virologically-confirmed dengue and the exposure is receipt of the dengue vaccine. Each case will be matched to two controls who were also eligible to have received the dengue vaccine and lives in the same area as the case. Cases and controls will be matched by age and sex.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dengue Severe Dengue Virologically Confirmed Dengue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Confirmed dengue case

Dengue cases who are 9-14 years old during the dengue mass vaccination program in Cebu with \<5 days history of fever, admitted in the participating hospitals with dengue virus confirmation by RT-PCR

No interventions assigned to this group

Control

Age and sex matched neighborhood controls

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

CASE-CONTROL STUDIES

* For a suspected case to be enrolled in the study, he/she should:

* Provide signed informed consent and assent (as applicable)
* Be within the age group eligible to receive the dengue vaccine at the time of mass vaccination (i.e. no condition that would have made him/her ineligible for dengue vaccination)
* Be admitted in any of the participating hospitals for suspected dengue
* Have ≤5 days history of fever.
* For controls to be recruited into the study, he/she should:

* Provide signed informed consent and assent (as applicable)
* Be age and sex-matched to the case
* Be from the same community as the matched case
* Be eligible to have received dengue vaccine during the community-based dengue immunization campaign in 2017 (i.e. no condition that would have made him/her ineligible for dengue vaccination)
* Have had no episode of clinically-diagnosed or laboratory-confirmed dengue fever from the start of the community -based dengue immunization campaign to the focal time (the date of onset of dengue fever in the matched case)
* Should not have been previously recruited as a control.

Exclusion Criteria

• Any subject whose parent/guardian refuse to provide informed consent and/or assent.

* In addition, the following conditions automatically exclude children from the dengue mass immunization:

* Children \<9 years or adults older than 45 years of age
* Anyone who is allergic or has had an allergic reaction to a prior dose or to any component of the dengue vaccine
* Recipient of blood product in the last 3 months
* Immunocompromised individuals, due to but not limited to genetic defects, HIV infection, or therapies that affect the immune system such as high-dose corticosteroids or chemotherapy
* Recipient of any vaccine within the past month
* History of bleeding disorder
* Pregnant or breastfeeding women
* Enrolled in dengue vaccine Phase 3 clinical study

Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes