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Dengue Tetravalent Vaccine

Phase 3

Dengue Fever | Vaccine | Infectious Disease |Takeda Pharmaceutical Company Limited|Trials Updated: Feb 7, 2024

Dengue Tetravalent Vaccine development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jul 2020

Dengue Tetravalent Vaccine target and mechanism

ModalityVaccine

Also known as Dengue Tetravalent Vaccine (TDV)

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment614

FDA Designations

No designations recorded

Dengue Tetravalent Vaccine clinical trials

Dengue Tetravalent Vaccine · 1 trial · 1 indication

Phase 3 1
NCT04313244Immunogenicity and Safety of Dengue Tetravalent Vaccine (TDV) and Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) in Participants Aged ≥9 to <15 YearsDengue Fever
COMPLETED614 Analytics
PHASE3COMPLETED
Immunogenicity and Safety of Dengue Tetravalent Vaccine (TDV) and Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) in Participants Aged ≥9 to <15 Years
Dengue FeverUnlock trial analytics

Study Endpoints

Primary Endpoints

Geometric Mean Titers (GMTs) for Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, 58
Day 210 (Month 7)

GMTs for HPV were measured by immunoglobulin G binding assay (IgGBA) assay. HPV-6, HPV-11, HPV-16, HPV-18, HPV-31, HPV-33, HPV-45, HPV-52 and HPV-58 were the types of HPV analyzed.

Secondary Endpoints

Percentage of Participants With Seropositivity for HPV Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 as Measured by Immunoglobulin G Binding Assay (IgGBA)
Day 210 (Month 7)
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes
Day 120 (Month 4)
Percentage of Participants With Seropositivity for Each of the 4 Dengue Serotypes
Day 120 (Month 4)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
9vHPV+TDVEXPERIMENTALParticipants will receive 0.5 mL 9vHPV intramuscularly (IM) with 0.5 mL TDV subcutaneously (SC) once on Day 1 (Month 0) followed by 0.5 mL TDV SC once on Day 90 (Month 3) and 0.5 mL 9vHPV IM once on Day 180 (Month 6).
9vHPVEXPERIMENTALParticipants will receive 0.5 mL 9vHPV vaccine IM once on Day 1 (Month 0) followed by 0.5 mL 9vHPV vaccine IM once on Day 180 (Month 6).

Interventions

NameTypeDescription
9vHPV VaccineBIOLOGICAL9vHPV intramuscular injection
Dengue Tetravalent Vaccine (TDV)BIOLOGICALTDV subcutaneous injection
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Eligibility Criteria

Age Range9 Years to 14 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: 1. Participants who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and the clinical judgment of the investigator. 2. Participants who can comply with trial procedures and are available for th...

Countries:Thailand
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Frequently asked questions about Dengue Tetravalent Vaccine

What is Dengue Tetravalent Vaccine (TDV)?

Dengue Tetravalent Vaccine (TDV) is an investigational vaccine developed by Takeda Pharmaceutical Company Limited for the prevention of dengue fever. It is designed to protect against dengue, a mosquito-borne viral infection. TDV has been studied in a Phase 3 clinical trial in Thailand involving 614 healthy participants aged 9 to under 15 years.

What is Dengue Tetravalent Vaccine (TDV) used for?

Dengue Tetravalent Vaccine (TDV) is being developed for the prevention of dengue fever, an infectious disease caused by dengue virus. The vaccine is intended for use in healthy individuals, including adolescents and children. Its clinical program has focused on participants aged 9 to under 15 years in Thailand.

Who makes Dengue Tetravalent Vaccine (TDV)?

Dengue Tetravalent Vaccine (TDV) is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical development program for this vaccine candidate.

What phase is Dengue Tetravalent Vaccine (TDV) in?

Dengue Tetravalent Vaccine (TDV) is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 3 trial evaluating TDV has been completed.

What clinical trials is Dengue Tetravalent Vaccine (TDV) in?

Dengue Tetravalent Vaccine (TDV) has been evaluated in a Phase 3 trial, NCT04313244, titled "Immunogenicity and Safety of Dengue Tetravalent Vaccine (TDV) and Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) in Participants Aged ≥9 to <15 Years." The trial enrolled 614 participants in Thailand and is completed.

Is Dengue Tetravalent Vaccine the same as TDV?

Yes, Dengue Tetravalent Vaccine is also known as Dengue Tetravalent Vaccine (TDV), often shortened to TDV. Both names refer to the same investigational vaccine developed by Takeda Pharmaceutical Company Limited for dengue fever prevention.