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Dengue Vaccine

Phase 1

Dengue Fever | Vaccine | Infectious Disease |GSK plc|Trials Updated: Feb 24, 2014

Dengue Vaccine target and mechanism

ModalityVaccine

Also known as Dengue Vaccine Formulation 17

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Dengue Vaccine clinical trials

Dengue Vaccine · 1 trial · 1 indication

Phase 1 1
NCT00384670A Phase I/II Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naïve ChildrenDengue Fever
COMPLETED7 Analytics
PHASE1COMPLETED
A Phase I/II Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naïve Children
Dengue FeverUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Solicited Adverse Events Within 21 Days After the First Dose of Dengue Vaccine.
21 days

Number of solicited general symptoms within the 21-day follow-up after dengue dose 1 (total vaccinated cohort).

Secondary Endpoints

Number of Unsolicited Adverse Events Within 30 Days After Each Dose of Dengue Vaccine
30 days
Number of Solicited Adverse Events for 21 Days (0-20) After the Second Dose of Dengue Vaccine
21 Days (0-20) After the Second Dose of Dengue Vaccine
Percentage of Individuals With Neutralizing Antibody (Seroconversion) to Japanese Encephalitis (JE) and 4 Dengue Types, 30 Days After the Second Dose of JE Vaccine.
30 days after the second dose of JE vaccine
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Dengue and Japanese Encephalitis vaccineEXPERIMENTAL1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.

Interventions

NameTypeDescription
Dengue Vaccine Formulation 17BIOLOGICALTetravalent live attenuated DEN vaccine candidate. Containing dengue serotypes 1,2, and 3 vaccines produced at the Salk Institute and dengue serotype 4 produced at the WRAIR Pilot Bioproduction Facility. Dosage 1 mL administered via injection at Day 0 and Day 60.
Licensed Japanese Encephalitis (JE) VaccineBIOLOGICALProduced by the Thailand GPO using a Beijing strain of JE in liquid form; dosed at 0.5 mL ot 7 and 7.5 months.
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Eligibility Criteria

Age Range6 Years to 10 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * A male or female child six to nine years of age (greater than or equal to 6 years of age and less than 10 years of age) at the time of the first vaccination. * Free of obvious health problems as established by medical history and physical examination before entering into the s...

Countries:Thailand
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Frequently asked questions about Dengue Vaccine

What is the Dengue Vaccine?

The Dengue Vaccine is an investigational vaccine being developed by GSK plc for the prevention of dengue fever, an infectious disease. It is a vaccine candidate that has been studied in early-stage clinical research. It is not yet an approved product.

What is the Dengue Vaccine used for in dengue fever?

The Dengue Vaccine is being developed for dengue fever, an infectious disease caused by dengue virus. The candidate is a vaccine intended to prevent the disease. It remains investigational and has only been evaluated in a Phase 1 clinical trial.

Who makes the Dengue Vaccine?

The Dengue Vaccine is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this dengue vaccine candidate.

What phase is the Dengue Vaccine in?

The Dengue Vaccine is in Phase 1 development. It is investigational and has not been approved. One Phase 1 trial has been completed, and no trials are currently active.

What clinical trials is the Dengue Vaccine in?

The Dengue Vaccine has been studied in one completed Phase 1 trial, NCT00384670, titled A Phase I/II Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naïve Children. The trial enrolled 7 participants in Thailand and has completed.

Is the Dengue Vaccine the same as Dengue Vaccine Formulation 17?

Yes. Dengue Vaccine Formulation 17 is another name for the Dengue Vaccine developed by GSK plc. Both names refer to the same investigational vaccine candidate for dengue fever.