Recent Updates
Recently added Catalysts

Dengue Vaccine Formulation 17

Phase 1

Dengue Fever | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Feb 24, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

Dengue Vaccine Formulation 17 · 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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Dengue Vaccine Formulation 17

What is Dengue Vaccine Formulation 17 used for?

Dengue Vaccine Formulation 17 is an investigational vaccine being developed for the prevention of Dengue Fever. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The vaccine is intended for use in individuals at risk of dengue infection.

Who makes Dengue Vaccine Formulation 17?

Dengue Vaccine Formulation 17 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational dengue vaccine.

What phase is Dengue Vaccine Formulation 17 in?

Dengue Vaccine Formulation 17 is in Phase 1 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The Phase 1 trial has been completed, and the vaccine remains in early-stage clinical evaluation for the prevention of Dengue Fever.

What clinical trials is Dengue Vaccine Formulation 17 in?

Dengue Vaccine Formulation 17 has been studied in one completed Phase 1 clinical trial, identified as NCT00384670. This trial was a Phase I/II study of a tetravalent live attenuated dengue vaccine in flavivirus antibody naive children, conducted in Thailand with 7 participants.

How does Dengue Vaccine Formulation 17 work?

Dengue Vaccine Formulation 17 is a tetravalent live attenuated dengue vaccine, meaning it contains weakened forms of all four dengue virus serotypes. It is designed to stimulate the immune system to produce protective antibodies against dengue virus infection, potentially reducing the risk of Dengue Fever.