QDENGA® (TAK-003) Dengue Vaccine Clinical Trials, Dosage, Indication, Side Effects
Takeda GmbH's QDENGA® (TAK-003) (Dengue Tetravalent Vaccine [Live, Attenuated]) is an approved two-dose vaccine preventing dengue fever and/or Severe Dengue caused by any of the four serotypes of the dengue virus. QDENGA is based on dengue serotype 2, which provides the genetic backbone for all four dengue virus serotypes. The active substance of QDENGA (ATC code: J07BX04) contains live attenuated dengue viruses, which replicate locally and elicit humoral and cellular immune responses against dengue serotypes.
Takeda's clinical development program for QDENGA consists of Phase 3, Phase 2, and Phase 1 studies. Data in children and adolescents showed that QDENGA induced immune responses against all four dengue serotypes in seropositive and seronegative participants. In addition, QDENGA was found to be generally safe and well-tolerated. In a Phase 2 study published on October 17, 2024, TAK-003 elicited durable T cell responses against all four DENV serotypes, regardless of baseline serostatus, in individuals aged 4–16 years residing in dengue-endemic countries. Furthermore, TAK-003-elicited CD4+ and CD8+ T cells were multifunctional and persisted for up to 3 years post-vaccination.
On December 8, 2022, QDENGA became the first dengue vaccine approved in Europe for use regardless of previous exposure and without the need for pre-vaccination testing. Europe's Committee for Medicinal Products for Human Use adopted a positive opinion on October 13, 2022, recommending that Takeda GmbH be granted marketing authorization for QDENGA EMEA/H/C/005155. In 2023, Brazil was the first country to integrate QDENGA into its public health system. The World Health Organization (WHO) added QDENGA® (TAK-003) to its List of Prequalified Vaccines, effective May 9, 2024. On May 3, 2024, the WHO published a paper on dengue vaccines, including final guidance on the use of QDENGA in public vaccination programs based on the SAGE recommendation. The WHO-SAGE recommends that TAK-003 be considered for public programs in high-transmission areas for individuals aged 6-16.
On November 3, 2025, Takeda announced data, including an exploratory analysis of a booster dose, confirming the favorable benefit-risk profile of QDENGA and that the two-dose regimen provides sustained protection against Dengue over 7 years. As of November 2025, QDENGA is authorized in the United Kingdom and a total of 41 countries.
Derek Wallace, President, Global Vaccine Business Unit, Takeda Pharmaceuticals, informed Vax-Before-Travel on November 6, 2025, "Dengue is spreading to areas once considered low-risk, with year-round peak seasons in many regions. These long-term data show that QDENGA's two-dose schedule provides sustained protection without a booster, simplifying vaccination efforts and improving our ability to combat Dengue globally."
Osaka-based Takeda Pharmaceutical Company Limited (TSE: 4502, NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people, and the planet in approximately 80 countries and regions. For more information about QDENGA (TAK-003), visit www.TakedaVaccines.com. QDENGA - Trademark Details: 2019-06-04.
QDENGA (TAK-003) Vaccine Availability 2025
The WHO recommends that countries consider introducing TAK-003 into their routine immunization programs in areas with high Dengue transmission intensity, where it poses a significant public health problem. Since 2022, QDENGA has been authorized in 41 countries, and 18.6 million doses have been distributed in 11 endemic countries including Indonesia (approved Aug 2022, available April 2023), Brazil (approved Mar 2023, available June 2023, Thailand (approved May 2023, available Aug 2023), Argentina (approved Apr 2023, available Oct 2023), Malaysia (approved Feb 2024, available June 2024), Colombia (approved Sept 2023, available July 2024), Germany (approved Dec 2022, available Feb 2023), Finland (approved Dec 2022, available Feb 2023), Sweden (approved Dec 2022, available Feb 2023), Norway (approved Dec 2022, available Feb 2023), Denmark (approved Dec 2022, available Mar 2023), The Netherlands (approved Dec 2022, available Mar 2023), Luxembourg (approved Dec 2022, available March 2023), Czech Republic (approved Dec 2022, available April 2023), Austria (approved Dec 2022, available April 2023), Belgium (approved Dec 2022, available April 2023), Ireland (approved Dec 2022, available April 2023), Portugal (approved Dec 2022, available May 2023), Spain (approved Dec 2022, available May 2023), U.K. (approved Jan 2023, available 2024), Slovakia (approved Dec 2022, available Aug 2023), Italy (approved Dec 2022, available Oct 2023), Poland (approved Dec 2022, available Dec 2023), Israel (approved May 2024, available July 2024), Switzerland (approved Aug. 2024), Malasyia, Thailand, and Vietnam. As of 2025, availability in the Philippines and India was [ending.
Qdenga (TAK-003) Vaccine Efficacy
A Takeda-funded study, based in Thailand, concluded on June 17, 2025, that the pragmatic introduction of TAK-003 into the immunization program would prevent 44% of cases and 53% of hospitalizations, resulting in $ 1.346 billion in savings over 20 years.
On October 17, 2024, the journal NPJ Vaccines published results from a study that concluded that TAK-003 was well tolerated and elicited durable T cell responses against all four dengue virus (DENV) serotypes, irrespective of baseline serostatus, in children and adolescents aged 4–16 years living in dengue-endemic countries. TAK-003-elicited CD4+ and CD8+ T cells were multifunctional and persisted for up to 3 years post-vaccination.
An exploratory analysis published on September 11, 2024 (December 2, 2024) demonstrated a vaccine efficacy (VE) of 82.1% for the onset of protection of TAK-003 in the three months between administering the first and second doses in the safety population. The journal Vaccine published a Short Communication on September 7, 2024, reporting that QDENGA's vaccine efficacy (VE) against disease was 82.1% up to 3 months after the first dose. On October 2, 2023, the WHO Strategic Advisory Group of Experts on Immunization (SAGE) confirmed that QDENGA demonstrated efficacy against all four serotypes of the virus in baseline seropositive children (4-16 years old) in endemic countries, as well as against serotypes 1 and 2 in baseline seronegative children. The SAGE recommended that the Vaccine be considered for introduction to children aged 6 to 16 years in settings with high dengue disease burden and high transmission intensity. Long-term efficacy results announced on June 9, 2022, supplemented previously published TIDES clinical study data, demonstrating QDENGA met its primary endpoint of overall VE against VCD, with 80.2% efficacy at 12-month follow-up, as well as all secondary endpoints for which there were a sufficient number of dengue cases at 18-month follow-up, including 90.4% VE against hospitalized Dengue. On May 20, 2021, an audio review of the Three-Year Efficacy of Takeda's Tetravalent Dengue Vaccine Candidate was published.
Qdenga (TAK-003) Time to Onset of Vaccine Efficacy
A study published in Vaccine on September 7, 2024, in the DEN-301 clinical trial estimated the Vaccine's efficacy onset to be approximately 2 weeks. Results from a study published in the Journal of Infectious Diseases on March 18, 2025, found that TAK-003 had a modest impact on asymptomatic dengue infections in the first months post-vaccination, particularly among baseline seropositive participants.
QDENGA and U.S. FDA
Takeda announced on July 11, 2023, that the Company voluntarily withdrew the U.S. Biologics License Application (BLA) for TAK-003 following discussions with the U.S. Food and Drug Administration (FDA) regarding data-collection aspects that could not be addressed within the current BLA review cycle. The plan for TAK-003 in the U.S. will be further evaluated, given the need for travelers and those living in dengue-endemic areas, such as Puerto Rico, Mexico, and Florida. On November 22, 2022, Takeda announced that the FDA had accepted and granted priority review of the Biologics License Application (BLA) for QDENGA to prevent dengue disease caused by any dengue virus serotype in individuals aged four years through 60 years.
QDENGA and U.S. CDC
During the U.S. Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) meeting on October 26, 2023, Dr. Gabriela Paz-Bailey (CDC/NCEZID) led a QDENGA update. Wilbur Chen, MD, presented Updates on Dengue Vaccines. On June 22, 2023, I reviewed the following presentations: ACIP Dengue Vaccines Work Group introduction, Wilbur Chen, MD, MSc; Economic analysis and health impacts of routine vaccination with TAK-003 dengue vaccine in San Juan, Puerto Rico; Summary of two economic models for dengue vaccine TAK-003 use in Puerto Rico; Partial Evidence to Recommendations Framework for Dengue Vaccine TAK-003, presented by Joshua Wong, MD. On February 23, 2023, the ACIP met to discuss the following presentations: Introduction, Dr. W Chen; Takeda dengue vaccine (TAK-003) safety and efficacy, Dr. Shibidas Biswal; Workgroup considerations, Dr. Gabriela Paz-Bailey. Previously, Laura Adams, DVM, MPH, DACVPM, led the U.S. CDC's Dengue Epidemiology vaccine overview on October 20, 2022, during the CDC/ACIP Dengue Vaccine Workgroup presentation.
QDENGA (TAK-003) Indication
Dengue is now detected in 129 countries and set a record for cases in 2024. As more travelers return to the U.S. with dengue virus infections, the risk of local mosquito-borne transmission increases. In European Union Member States, QDENGA is indicated for the prevention of dengue disease in individuals aged 4 years and above. It prevents Dengue, which is caused by the four Dengue serotypes. On May 15, 2024, the WHO confirmed that Qdenga is approved for use in children aged 6–16 in settings with a high dengue burden and transmission intensity. The WHO says TAK-003 does not prevent all cases of Dengue.
QDENGA (TAK-003) Dosage
Under the approved dosing regimen, QDENGA should be administered subcutaneously in a two-dose schedule (0 and 3 months) at a dose of 0.5 mL. The WHO SAGE recommends administering QDENGA in a 2-dose schedule with a 3-month interval between doses. QDENGA should be administered preferably in the upper arm in the deltoid region. QDENGA must not be injected intravascularly, intradermally, or intramuscularly. In Europe, the EMA approved after reconstitution, one dose (0.5 mL) contains Dengue virus serotype 1 (live, attenuated)*: ≥ 3.3 log10 PFU/dose Dengue virus serotype 2 (live, attenuated): ≥ 2.7 log10 PFU/dose Dengue virus serotype 3 (live, attenuated): ≥ 4.0 log10 PFU/dose Dengue virus serotype 4 (live, attenuated): ≥ 4.5 log10 PFU/dose.
On September 2, 2024, Vaccine published an analysis that concluded that one dose of TAK-003 was as effective as two doses.
QDENGA (TAK-003) Coadministraion
Co-administration with a hepatitis A vaccine has been studied without increased side effects or impaired antibody response. When co-administered with the yellow fever vaccine, a lower level of neutralizing antibodies against DENV1 was seen, the clinical significance of which is unclear.
QDENGA Co-Administration With HPV9 Vaccine
According to a recent phase 3 clinical study published in the journal Vaccines (Volume 62, August 30, 2025, 127558), dengue-endemic countries, such as the Kingdom of Thailand, have already initiated national Human Papillomavirus (HPV) school-based vaccination programs. Researchers wrote on July 30, 2025, 'Due to the overlapping age range targeted by many vaccines, including 9vHPV (Merck GARDASIL 9®) and TAK-003 (Takeda's QDENGA®), integration of Dengue vaccination into existing vaccination programs could be a beneficial approach to increase vaccine coverage and reduce operational costs.'
QDENGA (TAK-003) Side Effects
A Phase 4 study published by ScienceDirect (Volume 42, Issue 26) on October 4, 2024, identified anaphylaxis as a safety signal for TAK-003 vaccines in adolescents. Most anaphylaxis cases occurred 15 minutes after vaccination. In response, Brazil's Ministry of Health published recommendations to intensify efforts to ensure safe vaccination, including training for healthcare professionals and post-vaccination observation.
The ongoing Phase 3 study of TAK-003 demonstrated that rates of serious adverse events were 2.9% in the TAK-003 group and 3.5% in the placebo group during the continuing long-term follow-up (i.e., the second half of the three years following vaccination). Still, none of the cases were related to the study drug. The European Medicines Agency states that there is no clear evidence of an increased risk of severe dengue disease in individuals who have been previously infected with the disease.
QDENGA (TAK-003) Adverse Reactions
The most frequently reported adverse reactions post TAK-003 vaccination in subjects 4 to 60 years of age were injection site pain (50%), headache (35%), myalgia (31%), injection site erythema (27%), malaise (24%), asthenia (20%), and fever (11%). Very common (≥1/10 of subjects): upper respiratory tract infection, decreased appetite, irritability, headache, drowsiness, myalgia, injection site pain, injection site erythema, malaise, asthenia, and fever.
In February 2025, a study reported that Vaccine-related reactions were frequently reported, predominantly after the first dose in dengue-naïve participants.
QDENGA (TAK-003) Contraindications
Contraindications include hypersensitivity to the active substances or excipients listed, as well as a history of hypersensitivity to QDENGA. Individuals with congenital or acquired immune deficiency, including immunosuppressive therapies such as chemotherapy or high doses of systemic corticosteroids (e.g., 20 mg/day or 2 mg/kg body weight/day of prednisone for two weeks or more) within four weeks before vaccination. Individuals with symptomatic HIV infection or asymptomatic HIV infection, with impaired immune function, and pregnant and breastfeeding women.
QDENGA (TAK-003) Vaccination of Pregnant Women
A post-hoc analysis published on March 18, 2025, found no evidence of increased adverse pregnancy outcomes following unintentional TAK-003 vaccination occurring inside the exposure window compared with placebo.
QDENGA Format
Qdenga is available as a powder and as a solution for injection.
QDENGA (TAK-003) Vaccination Breakthrough Case
The immune response to dengue infection is complex and multifaceted, and the infection can progress to severe disease with limited clinical signs. This study, published in October 2024, examined a case involving a child who developed dengue symptoms after receiving the Qdenga vaccination. Despite initial negative diagnostic results, molecular analysis confirmed DENV4 infection.
QDENGA (TAK-003) Price
Takeda indicated in a March 16, 2023, presentation that the price of QDENGA in Indonesia would be USD 40 per dose, USD 26 ex-factory. For the travel market segment, vaccine pricing will be similar to that of other innovative travel vaccines in their respective countries. For example, the retail price in Germany would be USD 115 per dose. In Brazil, reports indicate QDENGA's price is about $171.
Qdenga (TAK-003) Vaccine Revenues
QDENGA Q4 FY2024 (April 2024-March 2025) Revenue was JPY 35.6B (+259%), QDENGA's FY2024 H1 Revenue was JPY 19.9B (+863% growth); FY2024 Q1 Revenue was JPY 9.5B (+1,099% growth).
QDENGA Vaccine Production
Biological E. Limited is committed to manufacturing up to 50 million QDENGA vaccine doses annually, accelerating Takeda's ability to deliver 100 million doses annually by 2030.
QDENGA Vaccine News
November 3, 2025 - "QDENGA is the most comprehensively studied dengue vaccine, with more than 60,000 participants globally in the clinical program, and these long-term data highlight the durability of its safety and efficacy profile, across diverse populations worldwide," said Derek Wallace, M.D., president of the Global Vaccine Business Unit at Takeda.
August 25, 2025 - A study reported: We find some evidence of a risk of vaccine-induced disease enhancement in seronegative vaccine recipients for dengue serotypes 3 and 4, especially for children under 6 years of age. Because of this, the benefits of vaccination in lower-transmission settings are less specific, and more data on the long-term efficacy of Qdenga against serotypes 3 and 4 are needed.
June 9, 2025 - Thailand's Public Health Minister Somsak Thepsuthin unveiled a new national strategy during the 2025 ASEAN Dengue Day event, which includes deploying QDENGA vaccinations in 2025.
February 18, 2025 - The Philippine Medical Association requested access to new-generation dengue vaccines.
September 7, 2024: The journal Vaccine published a Short communication titled "Early onset of protection of the TAK-003 dengue vaccine: Data from the DEN-301 clinical trial." The Estimated time to the onset of Qdenga vaccine efficacy was approximately two weeks.
May 10, 2024 - The World Health Organization prequalified Takeda's QDENGA vaccine. "The prequalification of TAK-003 is an important step in the expansion of global access to dengue vaccines, as it is now eligible for procurement by UN agencies, including UNICEF and PAHO," said Dr Rogerio Gaspar, WHO Director for Regulation and Prequalification.
May 9, 2024 - Takeda announced financial results for fiscal year 2023 (period ended March 31, 2024).
October 3, 2023 – Takeda announced that the WHO Strategic Advisory Group of Experts on Immunization issued recommendations for the use of QDENGA.
July 11, 2023 - "Our clinical program was designed to account for the complex global nature of dengue, and data from our 4.5-year trial has built confidence in TAK-003's ability to help provide long-term protection against dengue, with a positive benefit and risk profile regardless of baseline serostatus," said Gary Dubin, M.D., president of Takeda's Vaccines Business Unit.
June 22, 2023 - The U.S. CDC's Advisory Committee on Immunization Practices reviewed various dengue vaccine presentations.
May 23, 2023 - Filomeno Fortes, Director of Portugal's Institute of Hygiene and Tropical Medicine, confirmed the authorization of the Qdenga vaccine.
May 11, 2023 - Takeda announced its collaboration with Brazil's National Health Surveillance Agency. In March 2023, QDENGA received the first approval in Latin America.
March 13, 2023 - José Manuel Caamaño, president of Takeda in Brazil, stated in a press release, "We are proud to make our vaccine available to the Brazilian government and health care providers with the hope that it may become an important tool to help combat dengue as part of an integrated dengue management program along with vector control."
February 6, 2023 - Takeda UK Ltd. announced that the U.K.'s Medicines and Healthcare products Regulatory Agency had granted marketing authorization for Qdenga.
October 20, 2022: The U.S. CDC vaccine committee presented Dengue Epidemiology: Globally and in the U.S., including ACIP dengue vaccine recommendations.
October 14, 2022 - The EMA's human medicines committee recommended granting marketing authorization for the QDENGA Dengue Tetravalent Vaccine (Live, Attenuated) to prevent dengue virus serotypes 1, 2, 3, and 4 in individuals aged four years and above.
August 22, 2022: Gary Dubin, president of Takeda's Vaccine Business Unit, announced, "We're proud to introduce QDENGA as a new dengue prevention tool to the people of Indonesia. We will continue to work with additional regulatory agencies to make QDENGA available globally."
March 17, 2020 - The Lancet published the 'Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2–17.
November 6, 2019: Takeda's Dengue Vaccine Candidate Demonstrates Protection in Children Aged Four to 16, Regardless of Previous Dengue Exposure.
November 5, 2019 – Takeda Pharmaceutical Company announced plans for a new manufacturing plant in Singen, Germany, for TAK-003.
January 29, 2019 - Takeda announced that TAK-003, which is in a pivotal Phase 3 trial, met the primary efficacy endpoint.
September 7, 2016 - Takeda Initiated the Global Phase 3 Clinical Trial (TIDES) of the Dengue Vaccine Candidate (TAK-003).
QDENGA TAK-003 Clinical Trials
The approval of QDENGA is based on results from 19 Phase 1, 2, and 3 trials involving more than 28,000 children and adults, including 4.5 years of follow-up data from the global, pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. The study was designed in collaboration with the World Health Organization (WHO) for a second-generation dengue vaccine. A study published in the journal Vaccine on August 22, 2023, revealed that QDENGA had an efficacy of approximately 80.2% (95% CI, 73.3–85.3) against any serotype in the primary analysis. QDENGA's effectiveness declined over time, with 62% (95% CI, 56.6–66.7) efficacy at 3 years and 61.2% (95% CI, 56.0–65.8) at 4.5 years.
As of June 9, 2022, through four and a half years, TAK-003 demonstrated 84.1% vaccine efficacy (VE) (95% CI: 77.8, 88.6) against hospitalized Dengue, with 85.9% VE (78.7, 90.7) in seropositive individuals and 79.3% VE (63.5, 88.2) in seronegative individuals. TAK-003 also demonstrated an overall vaccine efficacy (VE) of 61.2% (95% CI: 56.0-65.8) against virologically confirmed Dengue (VCD), with 64.2% VE (58.4-69.2) in seropositive individuals and 53.5% VE (41.6-62.9) in seronegative individuals. Observations of VE varied by serotype and remained consistent with previously reported results. TAK-003 was generally well tolerated, and no critical safety risks were identified. No evidence of disease enhancement was observed during the 54-month exploratory follow-up analysis.
