A Phase I/II Trial of a Tetravalent Live Attenuated DEN Vaccine in Flavivirus Antibody Naive Children

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

PHASE1/PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2009-02-28

Brief Summary

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

One year follow-up on immunogenicity and safety of a booster dose of DEN vaccine administered approx. 1 year following the second dose

Related Clinical Trials

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

A Phase I/II Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naïve Children

NCT00384670

Dengue Fever

COMPLETED PHASE1/PHASE2

Efficacy and Safety of Dengue Vaccine in Healthy Children

NCT00842530

Dengue Virus Dengue Fever Dengue Hemorrhagic Fever +1 more

COMPLETED PHASE2

Immunogenicity of an Intradermal Qdenga Vaccine Among Healthy Volunteers

NCT06837116

Dengue

COMPLETED EARLY_PHASE1

A Study of Dengue Vaccine in Healthy Toddlers Aged 12 to 15 Months in the Philippines

NCT01064141

Dengue Fever Dengue Hemorrhagic Fever

COMPLETED PHASE2

Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule

NCT02623725

Dengue Fever Dengue Hemorrhagic Fever

COMPLETED PHASE2

Detailed Description

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

The purpose of this study is to find out more about the two doses of dengue vaccine, over a five year period, that the children received in the Dengue-003 study and to study a third dose of dengue that will be given to the children

* Do children still have dengue antibodies intended to provide protection against dengue infection one year after the two doses of vaccine given in study Dengue-003?
* Were there any major medical problems that appeared as dengue-like symptoms during the one year after vaccinations?
* Will a third dose of dengue help to further stimulate the part of the immune system intended to help protect against dengue infection?
* Is a third dose as safe as the first two doses?
* Are the local reactions to a third dose of the vaccine similar to what your child experienced after the first two doses?

Conditions

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

Dengue

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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

Total vaccinated

The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003

Group Type EXPERIMENTAL

DEN vaccine F17

Intervention Type BIOLOGICAL

The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).

Interventions

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

DEN vaccine F17

The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).

Intervention Type BIOLOGICAL

Other Intervention Names

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

Live attenuated tetravalent dengue (DEN) vaccine

Eligibility Criteria

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

Inclusion Criteria

* Subjects who received two doses of DEN vaccine in the Dengue-003 study
* Subjects whos parents signed an informed consent form were eligible for participation in the five year follow-up study