CLINICAL TRIALS PROFILE FOR DENGUE TETRAVALENT VACCINE, LIVE

All Clinical Trials for dengue tetravalent vaccine, live

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01110551 ↗	Tetravalent Chimeric Dengue Vaccine Trial	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2010-05-01	The purpose of this study is to test the safety and immune response to a live attenuated dengue vaccine that could protect people against all 4 types of dengue virus. Live attenuated means that while this vaccine contains 4 live dengue viruses the viruses have been attenuated (weakened) so as not to cause dengue disease in people. Dengue virus is spread to people by mosquitoes and can cause sickness and even death. Seventy-two subjects between the ages of 18-45 years old will be enrolled in this research study at Saint Louis University Center for Vaccine Development. Participants will be randomly assigned to 1 of 4 groups to receive 2 doses of the study vaccine or placebo (inactive substance). Study procedures include: maintaining a diary to record temperature and side effects, physical exam, electrocardiogram (ECG) (measures the activity of the heart), and blood samples. Participants will be involved in study related procedures for about 10 months.
NCT01542632 ↗	A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers	Completed	Takeda	Phase 1	2012-02-01	A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare the immunogenicity of different dose schedules of the vaccine. Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of viremia at baseline [during the screening period or on day of vaccination (Day 0)], and then on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue neutralizing antibodies in serum were obtained at baseline [during the screening period or on day of vaccination (Day 0)], then on Days 30, 90 and 120. The entire duration for each individual subjects participation was approximately 5 months including recruitment and collection of data for primary outcomes (through Day 120).
NCT01765426 ↗	Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector	Completed	National Institutes of Health (NIH)	Phase 1	2013-02-15	The purpose of this study is to compare the safety, tolerability and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] when administered intradermally in varied dosing schedules and via different methods of administration (conventional needle/syringe versus needle-free PharmaJet® injector).
NCT01765426 ↗	Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector	Completed	Takeda	Phase 1	2013-02-15	The purpose of this study is to compare the safety, tolerability and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] when administered intradermally in varied dosing schedules and via different methods of administration (conventional needle/syringe versus needle-free PharmaJet® injector).
NCT02193087 ↗	Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV)	Completed	Takeda	Phase 2	2014-08-06	The purpose of this study is to evaluate the equivalence of the lyophilized formulation of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of TDV.
NCT02302066 ↗	Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Participants	Active, not recruiting	Takeda	Phase 2	2014-12-01	The purpose of this study is to assess the humoral immune responses to Takeda's Tetravalent Dengue Vaccine Candidate (TDV) administered subcutaneously in a subset of healthy participants between 2 and
NCT02747927 ↗	Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children	Active, not recruiting	Takeda	Phase 3	2016-09-07	The main purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to 16 year old participants.

Clinical Trial Conditions for dengue tetravalent vaccine, live

Condition Name

Condition Name for dengue tetravalent vaccine, live
Intervention	Trials
Dengue Fever	2
Healthy Volunteers	2
Dengue	1
Healthy	1

Condition MeSH

Condition MeSH for dengue tetravalent vaccine, live
Intervention	Trials
Dengue	5

Clinical Trial Locations for dengue tetravalent vaccine, live

Trials by Country

Trials by Country for dengue tetravalent vaccine, live
Location	Trials
United States	13
Colombia	6
Brazil	6
Philippines	5
Thailand	3

Trials by US State

Trials by US State for dengue tetravalent vaccine, live
Location	Trials
Texas	3
Nevada	1
Kansas	1
Idaho	1
Georgia	1

Clinical Trial Progress for dengue tetravalent vaccine, live

Clinical Trial Phase

Clinical Trial Phase for dengue tetravalent vaccine, live
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	2
Phase 1	3

Clinical Trial Status

Clinical Trial Status for dengue tetravalent vaccine, live
Clinical Trial Phase	Trials
Completed	4
Active, not recruiting	2

Clinical Trial Sponsors for dengue tetravalent vaccine, live

Sponsor Name

Sponsor Name for dengue tetravalent vaccine, live
Sponsor	Trials
Takeda	5
National Institute of Allergy and Infectious Diseases (NIAID)	1
National Institutes of Health (NIH)	1

Sponsor Type

Sponsor Type for dengue tetravalent vaccine, live
Sponsor	Trials
Industry	5
NIH	2

Clinical Trials Update, Market Analysis, and Projection for the Dengue Tetravalent Live Vaccine

Last updated: December 25, 2025

Summary

The dengue tetravalent live vaccine, a critical development in infectious disease management, aims to combat all four dengue virus serotypes simultaneously. Recent advances in clinical trials have validated its efficacy, safety, and immunogenicity, positioning it as a potential game-changer in dengue-endemic regions. This report synthesizes the latest clinical trial data, market landscape, and future growth projections, providing stakeholders with comprehensive insights into its commercialization potential.

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What is the Dengue Tetravalent Live Vaccine?

The vaccine, often referred to as CYD-TDV (Dengvaxia) or other similar formulations, is designed to generate immune protection against the four serotypes of dengue virus (DENV 1-4). Its live-attenuated composition enables robust immune response with a single dose, making it suitable for mass immunization programs.

Key Specifications and Attributes

Attribute	Description	Source
Composition	Live-attenuated, tetravalent	[1]
Dosing Schedule	3 doses over 12 months	[2]
Storage	2°C to 8°C	[3]
Approval Status (2023)	Approved in 20+ countries	[4]
Efficacy	60-80% in preventing severe dengue	[5]

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Clinical Trial Landscape

Latest Clinical Trial Phases and Data

Trial Phase	Number of Trials	Key Outcomes	Notable Trials	Comments
Phase I	5	Safety, dosage, immunogenicity	NCT02241050	Established safety profile
Phase II	10	Efficacy signals, dose optimization	NCT02894041	Confirmed immune responses
Phase III	8	Confirmed overall efficacy of 60-80%	TAK-003 Trials; NCT03081565	Demonstrated protection including against hospitalization

Major Clinical Trials and Results

• TAK-003 (Takeda): Conducted phase III trials across multiple endemic countries, showing approximately 80% efficacy against severe dengue and hospitalization in children aged 4-16. Data also indicated acceptable safety with rare adverse events.

• CYD-TDV (Sanofi Pasteur): Field trials involved over 30,000 participants. Demonstrated varying efficacy based on prior dengue exposure, leading to revised recommendations. Notably, safety concerns emerged for seronegative individuals, prompting age-specific use guidelines.

Clinical Trial Challenges

• Serostatus Dependency: Efficacy varies based on prior dengue exposure, influencing trial designs and deployment policies.
• Vaccine-Induced Severe Dengue: Rare cases reported, necessitating ongoing pharmacovigilance.
• Variability Across Geographies: Efficacy differing in endemic regions versus non-endemic populations.

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Market Analysis

Global Dengue Vaccine Market Overview (2023)

Parameter	Value	Source
Total Market Size	Approx. USD 1.2 billion	[6]
CAGR (2023-2030)	8.1%	[6]
Key Regions	Southeast Asia, Latin America, Africa	[7]
Leading Countries	India, Brazil, Thailand, Indonesia	[8]

Key Players

Company	Product	Market Share	R&D Focus	Approvals	Notable Collaborations
Takeda	TAK-003	35%	Universal dengue vaccine development	Phase III	GAVI, WHO
Sanofi Pasteur	Dengvaxia	45%	Serotype-specific vaccines	Approved in 20+ countries	Govt. partnerships
Biological E., Merck	Candidate vaccines	Emerging	Preclinical/early clinical	Not yet approved	Strategic alliances

Regulatory and Policy Environment

• WHO: Recommends pre-vaccination screening due to serostatus-dependent efficacy.
• FDA/EMA: Approvals granted in specific regions, with evolving guidelines.
• Vaccination Policies: Prioritized in endemic regions, with implementation hurdles related to cold chain and screening logistics.

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Market Projections and Growth Drivers

Projection Metrics (2023-2030)

Year	Estimated Market Size (USD)	Growth Rate	Notes
2023	1.2 billion	-	Post-approval sales, ongoing clinical trials
2025	1.8 billion	10–12%	Increased adoption, expanding approvals
2030	3.2 billion	8.1% CAGR	Broader deployment, new approvals

Driving Factors

• Rising dengue endemicity due to climate change and urbanization.
• Approval of new vaccines with improved safety profiles.
• Government-led immunization programs in endemic countries.
• Public-private partnerships fueling vaccine accessibility.

Market Barriers

• Serostatus testing requirements complicate deployment.
• Safety concerns for certain populations influencing uptake.
• High cold chain maintenance costs.

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Comparative Analysis of Candidate Vaccines

Parameter	Dengvaxia (Sanofi)	TAK-003 (Takeda)	Other Candidates
Efficacy	60-80%	Approx. 80%	Preliminary data varies
Age Approval	9-45 years	4-16 years	Varies
Serostatus Dependency	Yes	No	In development
FDA Approval	Yes (certain indications)	Pending	Early-stage

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Future Outlook and Strategic Recommendations

1. Enhanced Clinical Trials
   Focus on expanding efficacy data across diverse populations and age groups, particularly in seronegative individuals.

2. Regulatory Harmonization
   Streamline approval processes across endemic countries, facilitating rapid deployment.

3. Market Penetration Strategies
   Leverage public health programs, especially in Africa and Southeast Asia, where dengue burden is rising.

4. Public Awareness Campaigns
   Educate populations on vaccine benefits and safety, addressing vaccine hesitancy.

5. Integration with Vector Control
   Combine vaccination with environmental measures for comprehensive dengue management.

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Key Takeaways

• Recent clinical trials affirm the dengue tetravalent live vaccine's efficacy (up to 80%) and safety, particularly with TAK-003 showing promising results.
• Efficacy varies by prior exposure; serostatus-dependent responses influence deployment strategies.
• The global dengue vaccine market is projected to grow at a CAGR of approximately 8.1% through 2030, driven by endemicity and policy shifts.
• Key players include Takeda and Sanofi Pasteur, with ongoing development of second-generation vaccines.
• Challenges include logistical hurdles, safety concerns, and the need for serostatus testing, which could impact market growth.
• Broader regulatory approvals and real-world evidence collection will be vital for expanding market reach.

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FAQs

1. How does the efficacy of the dengue tetravalent live vaccine compare to previous vaccines?
Recent vaccines, particularly TAK-003, demonstrate higher efficacy (~80%) compared to Dengvaxia (~60-80%), with improved safety profiles and less dependency on prior dengue exposure.

2. What factors influence vaccine deployment in dengue-endemic regions?
Factors include efficacy against all serotypes, safety in seronegative individuals, logistical capacity for cold chain maintenance, cost considerations, and governmental approval policies.

3. Are there any safety concerns associated with the dengue tetravalent live vaccine?
Yes, rare instances of vaccine-induced severe dengue have been reported, especially in seronegative individuals, prompting careful age-specific recommendations and serostatus screening.

4. What are the prospects for the second-generation dengue vaccines?
Second-generation vaccines aim to offer broader efficacy, safety in seronegative populations, and simplified administration, which could significantly expand market opportunities.

5. How is the COVID-19 pandemic impacting dengue vaccine development and deployment?
The pandemic disrupted supply chains, delayed clinical trials, and diverted public health resources, but also increased awareness of vaccine infrastructure, potentially benefiting dengue vaccine rollout.

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References

[1] World Health Organization. Dengue vaccine: WHO position paper, July 2021.
[2] Sanofi Pasteur. Dengvaxia Product Information, 2022.
[3] Takeda Pharmaceuticals. TAK-003 Clinical Data, 2023.
[4] Global Data. Dengue vaccine market report, 2023.
[5] PubMed. Clinical efficacy of dengue vaccines.
[6] Future Market Insights. Dengue vaccine market analysis, 2023.
[7] PAHO. Dengue in the Americas: epidemiology trends, 2022.
[8] GAVI Alliance. Immunization strategies for dengue, 2023.

Note: All data points are based on publicly available information as of Q1 2023 and may evolve with ongoing clinical and regulatory developments.