Qdenga (dengue tetravalent vaccine [live, attenuated]) / Takeda - LARVOL DELTA

Passive Safety Surveillance Data of Dengue Vaccine, Qdenga (TAK 003) in Private Vaccination Sites in Buenos Aires, Argentina. (clinicaltrials.gov) - P=N/A | N=112345 | Completed | Sponsor: Fundación Vacunar | Active, not recruiting ➔ Completed

Trial completion • Dengue Fever

Retrospective Analysis of the Second Year of Safety Surveillance of the Qdenga® (TAK-003) Vaccine in Private Vaccination Centers, Including a Sub-analysis of Safety in Adults Over 60 Years of Age (clinicaltrials.gov) - P=N/A | N=94526 | Active, not recruiting | Sponsor: Fundación Vacunar

New trial • Dengue Fever

Update on efficacy, safety, and immunogenicity of Dengue vaccines: a systematic review and meta-analysis. (PubMed, Infez Med) - "Chimeric Yellow Fever-Dengue Tetravalent Vaccine (CYD-TDV/Dengvaxia®) was assessed in 28 trials, 3 of which reported a pooled vaccine efficacy of 55% (95%CI 47%-62, I 2=86.9%; p <0.001) against Dengue...Takeda-003 (TAK-003/QDENGA®) was evaluated in 23 trials, showing sustained efficacy against virologically confirmed dengue (43.5%-82.1%) and high protection against hospitalization (approximately 87%-90%)...Other promising candidates included other investigational vaccines such as subunit (V180) or DNA-based (TVDV, D1ME100)...Emerging vaccine candidates, including TV003/TV005, Butantan-DV, TDEN, inactivated, subunit, and DNA-based platforms, have also shown promising safety and immunogenicity results in early-phase trials. Future attempts should focus on developing Dengue vaccines that provide safe, balanced, and durable protection against all four Dengue virus serotypes while minimizing the risk of antibody-dependent enhancement, focusing also on special..."

Journal • Retrospective data • Review • Dengue Fever • Infectious Disease

Strengthening public understanding and prevention of dengue in Malaysia: insights and recommendations based on knowledge, attitudes, and practices toward vector control and vaccination. (PubMed, Front Public Health) - "A total of 41% expressed high willingness to receive a dengue vaccine, as measured before a dengue vaccine TAK-003 (Qdenga) became available in Malaysia...Efforts should focus on addressing misconceptions on dengue and vaccination, strengthening communication through trusted channels, and promoting more consistent adoption of vector control practices. Improving access to clear and reliable information on dengue vaccines will be critical to reducing hesitancy and supporting uptake."

Journal • Cognitive Disorders • Dengue Fever • Infectious Disease • Novel Coronavirus Disease

TAK-003 Dengue Vaccine Safety: Evidence from a Systematic Review and Meta-analysis of Clinical Trials. (PubMed, Indian J Community Med) - "TAK-003 shows an acceptable safety profile, with no rise in SAEs or mortality. Although local and mild systemic reactions were more common, they were brief and tolerable, supporting an acceptable safety profile within the available randomized clinical trial evidence."

Clinical • Journal • Retrospective data • Review • Dengue Fever • Musculoskeletal Pain • Pain

Serotype skewing and immune imprinting shape response to the tetravalent dengue virus Qdenga vaccine. (PubMed, J Exp Med) - "These findings clarify why balanced tetravalent immunity is rarely achieved with Qdenga and demonstrate that both immune imprinting and vaccine backbone limit the breadth and magnitude of the responses. This has important implications for deployment, long-term protection in naive populations, and DENV-4-targeted boosters."

Journal • Dengue Fever • Infectious Disease

Mapping immune responses to TAK-003 dengue vaccine: immunogenicity across the clinical development program. (PubMed, Front Immunol) - "In this review, we summarise the magnitude, quality, and functionality of humoral and cellular immune responses following the first and second doses of TAK-003 across age, region, and DENV serotype. We also outline long-term persistence and durability, ongoing investigations into correlates of protection, age-stratified responses, and evidence on co-administration with other vaccines."

Journal • Review • Dengue Fever

Characterization of vaccine viremia, attenuation reversion, and safety: Combined results from the TAK-003 dengue vaccine clinical development program. (PubMed, Vaccine) - "In the DEN-301/DEN-313 analysis, participants with febrile illness showed a similar pattern of symptoms with and without RNAemia. The presence of RNAemia was associated with transient, mild-to-moderate symptoms, resembling natural infection, which were also observed in the absence of RNAemia."

Journal • Dengue Fever • Dermatology • Fatigue • Infectious Disease • Musculoskeletal Pain • Pain

In a major step towards dengue prevention, the Central Drugs Standard Control Organisation (CDSCO) has approved Japanese drug maker Takeda Pharmaceutical's QDENGA (TAK-003), making it the first dengue vaccine to receive approval in India. (New Indian Express) - "The approval is based on Takeda's global clinical development programme involving 19 Phase 1, 2 and 3 clinical trials with more than 28,000 participants. The Phase III TIDES (DEN-301) trial involving more than 20,000 participants across eight countries showed an overall vaccine efficacy of 80.2% against virologically confirmed dengue 12 months after the second dose."

Approval • Dengue Fever

Shared evidence, different recommendations: a comparative analysis of Qdenga (TAK-003) dengue vaccine guidance for travellers across countries. (PubMed, J Travel Med) - "Variation in Qdenga guidance reflects differences in how advisory bodies interpret shared evidence and manage uncertainty arising from data gaps and differences between trial populations and travellers. Additional data on vaccine effectiveness and clinical outcomes among seronegative travellers and older adults may help reduce uncertainty and support greater alignment of future recommendations. Regardless, transparency and shared clinical decision-making remain essential when discussing dengue vaccination with travellers."

Journal • Dengue Fever • Infectious Disease

A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults (clinicaltrials.gov) - P3 | N=496 | Active, not recruiting | Sponsor: Takeda | Trial completion date: Jul 2027 ➔ Dec 2026

Trial completion date • Dengue Fever

Beyond neutralization: A comprehensive framework for evaluating humoral immunity induced by a live-attenuated tetravalent dengue vaccine. (PubMed, Vaccine) - P2, P3 | "TAK-003 vaccination elicited multiple non-overlapping, unique humoral immune responses. Data support including parameters in addition to NAbs to better assess vaccine-induced humoral responses."

Journal • Dengue Fever • Infectious Disease

Serotype skewing and immune imprinting shape response to the tetravalent dengue virus Qdenga vaccine. (PubMed, medRxiv) - "These findings clarify why balanced tetravalent immunity is rarely achieved with Qdenga and demonstrate that both immune imprinting and vaccine backbone skewing limit the breadth and magnitude of the responses. This has important implications for deployment strategies, long-term protection in DENV-naïve populations, and the need for booster strategies focusing on tetravalent coverage, especially for DENV-4."

Journal • Dengue Fever • Infectious Disease

Hypersensitivity reactions to dengue vaccine TAK-003 (Qdenga®) following an immunization campaign targeting children and adolescents. (PubMed, Rev Soc Bras Med Trop) - "Hypersensitivity rates exceeded expected vaccine-associated levels, reinforcing the need for continued pharmacovigilance."

Journal • Dengue Fever • Immunology

POST-MARKETING SAFETY PROFILE OF TAK-003: REAL-WORLD EVIDENCE FROM ARGENTINA, BRAZIL, AND GERMANY (ESPID 2026) - "These findings support continued implementation in vaccination programmes with routine safety monitoring. Sponsorship: Takeda Pharmaceuticals International AG"

Clinical • HEOR • P4 data • Real-world • Real-world evidence • Dengue Fever • Infectious Disease

A QUALITATIVE STUDY OF TAK-003 DENGUE VACCINE SAFETY SURVEILLANCE IN REAL-WORLD SETTINGS: INSIGHTS FROM ARGENTINA, BRAZIL, AND GERMANY (ESPID 2026) - "Conclusions/Learning Points These lessons learned can be leveraged by public and private sectors in different settings to inform safety surveillance. Furthermore, they can support robust and reliable real-world data collection to complement TAK-003's well-established safety profile."

Clinical • Real-world • Real-world evidence • Dengue Fever • Infectious Disease

CHARACTERIZATION OF IMMUNIZATION ERRORS FOLLOWING THE INTRODUCTION OF THE QDENGA® VACCINE IN A PEDIATRIC POPULATION IN SÃO PAULO, BRAZIL: A DESCRIPTIVE STUDY (ESPID 2026) - "Conclusions/Learning Points These findings emphasize the need for robust surveillance to detect immunization errors. Enhancing healthcare professional training, improving access to vaccination records, and ensuring adherence to guidelines are key to patient safety and effective vaccination programs."

Clinical • Dengue Fever • Infectious Disease • Influenza • Meningococcal Infections • Novel Coronavirus Disease

TOLERABILITY AND CLINICAL PROFILE OF DENGUE VACCINATION IN A PEDIATRIC TRAVEL COHORT (ESPID 2026) - "This study evaluated the experience of QdengaÒ dengue vaccination in children (indicated for ages ≥4 years)...VFR travelers were the most frequently vaccinated, particularly to Central and South America. Many children had incomplete vaccination before travel, highlighting the need for early pre-travel counseling and vaccination at least three months in advance."

Clinical • Dengue Fever • Infectious Disease

TTV Viremia and Immune Responses Following Vaccination Against Mpox and Dengue Viruses. (PubMed, Vaccines (Basel)) - "Humoral and cellular responses to MVA-BN (for MPXV) and QDENGA (for DGV) vaccines were measured by using serology, neutralization assays, and interferon-γ ELISpot, and correlations with TTV viremia were investigated... TTV viremia does not predict vaccine immunogenicity in immunocompetent or mildly immunosuppressed individuals. These results, which derive from within-cohort analyses and do not rely on direct comparisons between heterogeneous vaccine populations, support the role of TTV as a marker of immune status along a continuum of immunosuppression, with predictive value likely confined to populations with more severe immune impairment."

Journal • Dengue Fever • Human Immunodeficiency Virus • Infectious Disease • IFNG

PRIME-Q: A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia (clinicaltrials.gov) - P=N/A | N=2000 | Active, not recruiting | Sponsor: Takeda | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • Real-world evidence • Dengue Fever

CD8+ T cells and Humoral Immunity Influence the Development of Antibody-Dependent Enhancement: Implications for Vaccine Design. (PubMed, bioRxiv) - "ADE complicates dengue vaccine development; signals of ADE were observed in the CYD-TDV (Dengvaxia) vaccine trials but have not yet been reported for trials of TAK-003 (Qdenga)...The model predicts that CD8+ T-cell responses can mitigate ADE-associated pathology and may help explain the differing levels of protection observed for CYD-TDV and TAK-003 vaccines. These findings suggest that evaluating CD8+ T-cell responses alongside antibody titers may be important for assessing vaccine safety and protection."

Journal • Dengue Fever • Infectious Disease • CD8

Demographic Characteristics of TAK-003 Dengue Vaccine Recipients in Vietnam (clinicaltrials.gov) - P=N/A | N=800000 | Active, not recruiting | Sponsor: Tam Anh Research Institute

New trial • Dengue Fever

Towards national guidance on dengue and chikungunya vaccination in travellers: Lessons from global recommendations. (PubMed, Travel Med Infect Dis) - "Recent approvals of Qdenga (TAK-003) for dengue and IXCHIQ (VLA1553) for chikungunya have expanded preventive options. Based on this analysis, we propose tailored recommendations for Poland, prioritising vaccination of travellers with documented prior dengue infection and high exposure risk, alongside strengthened personal protective measures and pre-travel counselling. The analytical framework presented may also support policy development in other non-endemic countries."

Journal • Review • Chikungunya • CNS Disorders • Dengue Fever • Infectious Disease

Adult dengue vaccination in a low transmission setting: A modelling study in Singapore. (PubMed, PLoS Negl Trop Dis) - "Qdenga (TAK-003), a commercially available dengue vaccine, has been recommended by the World Health Organization Strategic Advisory Group of Experts (WHO-SAGE) for use in high-transmission settings...Our model-based analysis provides useful insights to support policymakers and public health authorities in designing evidence-based, dengue vaccination strategies in Singapore. The findings also underscore the importance of tailoring dengue vaccination programs to local epidemiological conditions for effective disease control."

Journal • Dengue Fever

Humoral and cellular responses to a tetravalent dengue vaccine (TAK-003) in adults from a dengue non-endemic region: An open-label phase 2 trial. (PubMed, Vaccine) - P2 | "TAK-003 was well tolerated and elicited tetravalent humoral and cellular immune responses sustained for at least 12 months in flavivirus seronegative and dengue seropositive adults residing in areas without DENV circulation."

Journal • P2 data • CNS Disorders • Dengue Fever • Infectious Disease • CD4 • CD8 • IFNG • IL2 • TNFA