Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-02

Study Completion Date

2013-01-31

Brief Summary

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

The purpose of this study was to evaluate the safety and immunogenicity of Phase III lots of the CYD dengue vaccine in a pediatric population in Malaysia.

Primary Objectives:

* To describe the safety (in terms of solicited and unsolicited adverse events) of the CYD dengue vaccine in all participants after each injection.
* To describe the antibody response to each dengue virus serotype post-injection 2 and post-injection 3.

Related Clinical Trials

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

A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia

NCT06388785

Dengue Fever

RECRUITING

Phase III Trial to Evaluate Efficacy and Safety of a Tetravalent Dengue Vaccine

NCT02406729

Dengue

ACTIVE_NOT_RECRUITING PHASE3

A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India

NCT06060067

Healthy Volunteers

COMPLETED PHASE3

Investigating Vector-Borne Determinants of Aedes Transmitted Arboviral Infections in Cambodia: An Observational Longitudinal Cohort Study in Children

NCT03534245

Dengue Fever

COMPLETED

Dengue Vaccine Hesitancy Among International Travelers

NCT06418854

Vaccine Hesitancy

COMPLETED NA

Detailed Description

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

Healthy participants aged 2 to 11 years received 3 vaccinations at pre-determined schedules and were followed-up for at least 6 months after the last vaccination.

Conditions

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

Dengue Fever Dengue Hemorrhagic Fever

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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

CYD Dengue vaccine group

Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.

Group Type EXPERIMENTAL

Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus

Intervention Type BIOLOGICAL

0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension

Placebo Group

Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.

Group Type PLACEBO_COMPARATOR

Placebo: NaCl 0.9%

Intervention Type BIOLOGICAL

0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus

0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension

Intervention Type BIOLOGICAL

Placebo: NaCl 0.9%

0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CYD Dengue vaccine Saline

Eligibility Criteria

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

Inclusion Criteria

* Aged 2 to 11 years on the day of inclusion
* Assent form was signed and dated by the participant (for participants ≥ 7 years) and informed consent form was signed and dated by the parent(s) or another legally accepted representative, and by an independent witness if the two parents or legally accepted representative were illiterate
* Participant and parent/legally accepted representative were able to attend all scheduled visits to comply with all trial procedures
* Participants in good health, based on medical history and physical examination
* For a female participant of childbearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination

Exclusion Criteria

* Known pregnancy, or a positive urine pregnancy test (for female participant of child-bearing potential only)
* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
* Planned participation in another clinical trial during the present trial period
* Planned receipt of any vaccine in the 4 weeks following the trial first vaccination, except for pandemic influenza vaccination
* Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Seropositivity for human immunodeficiency virus (HIV) reported by the parent/legally acceptable representative
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
* Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion
* Participants who plan to move to another country/region within the 18 coming months
* Identified as a child (adopted or natural) of the Investigator or of site employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center.

Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes