Last reviewed 2026-04-23 · How we verify

TAK-003

TAK-003 is a live attenuated tetravalent dengue vaccine that stimulates immune responses against all four dengue virus serotypes.

TAK-003 is a live attenuated tetravalent dengue vaccine that stimulates immune responses against all four dengue virus serotypes. Used for Prevention of dengue fever caused by dengue virus serotypes 1, 2, 3, and 4 in endemic populations.

At a glance

Mechanism of action

TAK-003 contains weakened forms of all four dengue virus serotypes (DENV-1, DENV-2, DENV-3, DENV-4) designed to induce both humoral and cellular immune responses without causing disease. The vaccine primes the immune system to recognize and neutralize dengue viruses upon natural exposure, reducing the risk of symptomatic dengue infection and severe dengue disease.

Approved indications

• Prevention of dengue fever caused by dengue virus serotypes 1, 2, 3, and 4 in endemic populations

Common side effects

• Injection site pain or erythema
• Myalgia
• Headache
• Fever

Key clinical trials

• A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults (PHASE3)
• A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years) (PHASE3)
• A Study of Dengue Tetravalent Vaccine (TDV) in Healthy Participants in Japan (PHASE2, PHASE3)
• A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India (PHASE3)
• Evaluation of T-cell Responses After Vaccination With the Attenuated Tetravalent Dengue Vaccine (Takeda).
• A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers (PHASE3)
• Characterisation of Dengue Vaccine-induced Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination
• Passive Safety Surveillance Data of Dengue Vaccine, Qdenga (TAK 003) in Private Vaccination Sites in Buenos Aires, Argentina.

Primary sources

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