A Phase 3, Randomized, Double-Blind, Placebo-Controlled (Older Adults, Aged >60 to 79 Years) and Open-Label (Adults, Aged 45 to 60 Years), Multicenter Trial to Investigate the Safety and Immunogenicity of a Dengue Tetravalent Vaccine (TDV) Administered Subcutaneously to Adults and Older Adults With or Without Comorbidities in Endemic Areas for Dengue

Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. Researchers have seen that dengue fever now also happens more often in elderly persons. The main aim of this study is to learn more about the side effects of TDV in adult (45 - 60 years) and elderly (60 - 79 years) persons and about TDV's ability to create an immune response in adult and elderly persons. Another aim is to learn about the side effects of TDV in adult and elderly persons in endemic countries who have one or more additional medical conditions (called comorbidities) such as diabetes mellitus, hypertension or a chronic kidney condition.
In this study, participants will receive 2 vaccinations with TDV (the second 3 months after the first).
During the study, participants will visit their study clinic 5 times.

Start Date01 Apr 2026

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT07047521

/ Not yet recruitingPhase 3

A Randomized, Double-Blind, Phase 3 Trial to Investigate the Immunogenicity and Safety of a New Formulation of Tetravalent Dengue Vaccine (TDV) Versus the Current Formulation of TDV in Healthy Adults (Aged 18-60 Years) in a Non-Endemic Area for Dengue

Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. The TDV in current formulation has been approved by health authorities in many countries around the world. The main aim of the study is to confirm that the TDV new formulation induces the similar immune response as approved TDV.
Healthy adults who live in an area in which dengue fever does not occur will receive 2 TDV vaccinations 3-months apart with either the new or the current TDV. Blood samples will be taken before and after the vaccinations. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 5 times.

Start Date17 Nov 2025

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT06665035

/ RecruitingPhase 3

A Randomized, Age-Descending, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Safety and Immunogenicity of 2 Doses of a Subcutaneous Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Within the Routine Vaccination Schedule of Pediatric Participants ?6 Months to <21 Months of Age

Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. The purpose of this study is to collect information of vaccination with TDV when given to children younger than 2 years. The main aims of this study are to learn how safe the vaccine is and how well it works to activate a young child's immune system (this is called immunogenicity). Children between the age of 6 and 21 months will receive two vaccinations with either TDV or placebo 3 months apart. Blood samples will be taken before and after the vaccination as well as throughout the study. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 8 times for vaccinations, blood draws and health checks.

Start Date16 Jun 2025

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

100 Clinical Results associated with Dengue vaccine tetravalent(Takeda)

100 Translational Medicine associated with Dengue vaccine tetravalent(Takeda)

100 Patents (Medical) associated with Dengue vaccine tetravalent(Takeda)

274

Literatures (Medical) associated with Dengue vaccine tetravalent(Takeda)

31 Dec 2025·Human Vaccines & Immunotherapeutics

Travel medicine providers’ opinions on the dengue vaccine TAK-003 as a travel vaccine and the need for decision-support information and materials before its launch in Japan

Article

Author: Fukushima, Shinji ; Fukunishi, Atsuko ; Machida, Masaki ; Inoue, Shigeru

TAK-003 is a dengue vaccine introduced in dengue-endemic countries and considered for travelers. Although not yet approved in Japan, inquiries from travelers are increasing. With limited evidence about vaccine use for travelers, consolidated expert opinions would aid in vaccination decision-making. Therefore, this study examined the opinions on TAK-003 and the need for decision-support information and materials among travel medicine providers before its launch in Japan. Participants recruited from the Japanese Society of Travel and Health were assessed on their intention to receive TAK-003 themselves when visiting dengue-endemic areas, and their intention to recommend it to travelers, with responses provided separately for short- and long-term travels. Participants who did not recommend TAK-003 provided reasons using multiple-choice questions. All participants were asked about their need for supporting information to aid in vaccination decision-making. Among the 154 respondents, over half intended to receive (55% for short-term, 75% for long-term) and recommend (53% for short-term, 75% for long-term) the vaccination. The primary reasons for not recommending it were concerns about efficacy and safety, which were also the most requested support information. These findings suggest that many travel medicine providers have positive opinions on TAK-003 as a travel vaccine and need decision-support information and materials.

31 Dec 2025·Expert Review of Vaccines

TAK-003: development of a tetravalent dengue vaccine

Review

Author: Sharma, Mayuri ; Dean, Hansi ; Low, Jenny Guek Hong ; Kosalaraksa, Pope ; Sáez-Llorens, Xavier ; DeAntonio, Rodrigo ; Tricou, Vianney ; Biswal, Shibadas

INTRODUCTION:

Dengue incidence has increased over the past few decades. One tetravalent dengue vaccine based on a yellow fever backbone has been approved, but due to increased risk of severe disease in dengue-naïve recipients, its use is limited to individuals with prior dengue exposure.

AREAS COVERED:

We summarize the clinical development of TAK-003, a tetravalent dengue vaccine based on a live-attenuated DENV-2 backbone. We discuss vaccine development and preclinical and clinical work leading to a commercially available formulation. TAK-003 is approved in several countries and the WHO-SAGE recommend TAK-003 to be considered for public programs in high transmission areas for individuals aged 6-16 years. Finally, we discuss the potential role of TAK-003 as part of an integrated multimodal strategy for dengue prevention.

EXPERT OPINION:

TAK-003 has been assessed in a comprehensive clinical development program; demonstrating sustained efficacy and safety against all four serotypes in baseline seropositive individuals, and against DENV-1 and DENV-2 in seronegative individuals, and has been well tolerated. Effectiveness in a real world setting and safety will be monitored in ongoing and future studies, particularly for DENV-3 and DENV-4, together with the impact of a booster dose. Overall, TAK-003 shows promise as a new tool for dengue prevention.

31 Dec 2025·Expert Review of Vaccines

Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine

Article

Author: Youard, Zeb ; Zent, Olaf ; Patel, Sanjay S. ; Faccin, Alice ; Pang, Hang ; Rauscher, Martina

BACKGROUND:

The tetravalent dengue vaccine TAK-003 is contraindicated during pregnancy. Pregnant women were excluded from TAK-003 clinical studies; however, some pregnancies occurred unintentionally.

RESEARCH DESIGN AND METHODS:

This post-hoc analysis of phase 2 and 3 studies, evaluated pregnancy outcomes and neonatal adverse events (AEs) following unintentional vaccination during the time period ('exposure window') when women could be pregnant (within 44 days before last menstrual period until the outcome of pregnancy).

RESULTS:

Of the 557 reported pregnancies, 38 (TAK-003, n = 28/375; placebo, n = 10/182) occurred inside the exposure window. Of these, 28 (TAK-003, n = 23; placebo, n = 5) resulted in live births, four resulted in elective terminations (TAK-003, n = 2; placebo, n = 2), five in spontaneous abortions (TAK-003, n = 3; placebo, n = 2) and one unknown outcome (placebo).Of the spontaneous abortions, there was no significant difference between TAK-003 and placebo recipients, or between those occurring within or outside the exposure window. Six participants who received TAK-003 in the exposure window and two neonates experienced serious AEs; none were considered TAK-003 related.

CONCLUSIONS:

This post-hoc analysis found no evidence of increased adverse pregnancy outcomes following unintentional TAK-003 vaccination occurring inside the exposure window compared with placebo.

CLINICAL TRIAL REGISTRATION:

The clinical trials from which data were extracted are registered at www.clinicaltrials.gov (identifiers are NCT02193087, NCT01511250, NCT02302066, NCT02425098, NCT03746015, NCT02747927, NCT03999996, NCT03423173, NCT03342898, NCT03771963, NCT04313244, NCT02948829, NCT035252119, NCT03341637).

News (Medical) associated with Dengue vaccine tetravalent(Takeda)

08 May 2025

·www.fiercepharma.com

Takeda looks toward 'inflection point' as it eyes new launches to shake off Vyvanse generic impacts

The Japanese drugmaker is looking to embark on a new path for growth as it leaves generics-ridden ADHD med Vyvanse behind. This time last year, Takeda was scrambling to accommodate for rapidly sinking profits from the hasty decline of ADHD mainstay Vyvanse with a 140 billion Japanese yen ($899 million) restructuring campaign. Now, things are looking up for the Japanese drugmaker with several key products keeping it afloat as it looks to unlock a new path to growth with upcoming launches.While six new launches are expected to help weather the storm ahead of biosimilar competition to lead sales driver Entyvio at the end of the decade, three “potentially life-transforming” new treatment options are on track for phase 3 readouts this year, the company said in its 2024 full-year earnings release. Takeda’s fiscal year just wrapped up in March 2025 and began in April 2024.2025’s fiscal year, meanwhile, will be “pivotal” as it invests in launch readiness, which is key for the company’s long-term growth potential despite a flat 2025 outlook, CEO Christophe Weber commented. Rusfertide, a treatment for chronic blood disorder polycythemia vera that Takeda bought from Protagonist Therapeutics for $300 million last year, already delivered a phase 3 win in March. The company expects that the buy will be well worth it with $1 billion to $2 billion in potential peak revenue and previously noted that FDA submissions are expected in 2025. Elsewhere, the first half of the year should see a phase 3 readout for narcolepsy type 1 treatment oveporexton, which is looking at $2 billion to $3 billion in peak sales, while the latter half of the year should have phase 3 data from zasocitinib, a TYK2 inhibitor that could “redefine what is possible” as an oral therapy for psoriasis. That one has the greatest potential revenues with $3 billion to $6 billion.Together, the three make an “inflection point” for the company, said Chief Financial Officer Milano Furuta, who is “excited about our growth trajectory." Takeda is hoping that the boosts to come will help it shake off the ghost of its Vyvanse past, its longtime top-selling ADHD med that succumbed to generic competition in late 2023 after 16 years of market exclusivity. The company described its 2025 outlook (PDF) as the final year of “significant” generic headwind to the med, although it may be worth noting that it said the same last year about its 2024 expectations. Nonetheless, the new launch preparations and an expected 30% sales slide for Vyvanse are anticipated to leave revenue at a “broadly flat” 4.5 trillion yen ($31 billion).That forecast does not reflect the potential impact of pharmaceutical-specific tariffs, Takeda noted, although it will “continue to monitor the situation.” Since 50% of its revenue comes from the U.S. and its imports make up only about 8% to 10% of its total U.S. revenue, the company’s potential exposure to tariffs are “limited,” it explained. The drugmaker is meanwhile taking “mitigation measures” for imports that may be impacted by tariffs, detailing its current global manufacturing network as 22 internal sites with 20 that supply the U.S. and 7 located in the U.S.Takeda did however also make some major cuts across its experimental drug pipeline. This includes the axing of three cancer candidates that has now halved the number of all oncology meds in Takeda’s phase 1 and 2 pipeline.Over 2024, Takeda reported a 7.5% boost in revenue to 4.6 trillion Japanese yen ($31.8 billion), although net profit fell 25.1%. Weber attributed its “multi-year efficacy program” to the company’s 4.9% bump in core operating profit growth. So fair, said program, which was unveiled last year to reduce layers and encourage organizational simplicity, added up to around 200 billion Japanese yen ($1.38 billion) in annualized savings to date and has prompted 3,000 layoffs (PDF) so far.The company’s "growth and launch" collection includes several products across its six key business areas and made up 48% of its total core revenue. Inflammatory bowel disease (IBD) drug Entyvio is Takeda’s top growth driver and is “maintaining share leadership” even as the IBD market becomes more and more crowded with fierce competition from AbbVie's Skyrizi and Rinvoq, among others. Still, the company touts it as the #1 brand in IBD and is bolstered by its newly launched pen option.Other growth drivers include metastatic colorectal cancer (mCRC) treatment Fruzaqla, which grew 351% to 48 billion Japanese yen ($331 million) and is seeing “strong uptake” in the U.S., while dengue vaccine Qdenga is on track to hit 100 million manufactured doses by 2030.

AcquisitionPhase 3Biosimilar

28 Apr 2025

·pharma.economictimes.indiatimes.com

Dengue vaccine 'Qdenga' to launch in India next year

New Delhi: Japanese major Takeda plans to launch its dengue vaccine, Qdenga, in India next year, partnering with Hyderabad-based Biological E (Bio E) to align with the 'Make-in-India' initiative. Having recognised dengue as a "global health challenge," the over $23 bn company will adopt a "tiered pricing model for its first global vaccine to maximise access'', Derek Wallace, president, global vaccine business unit, Takeda, told TOI in an exclusive interview. The company, with focus on oncology, rare diseases and gastroenterology, negotiates lower prices for centralised govt procurement on a country-by-country basis, and a similar strategy will be implemented in India, he said. Elaborating on the regulatory process, he said, it "is ongoing and on track", with clinical trials underway to generate local safety data. "We've already submitted a comprehensive data package that supported registration in 40 countries and we anticipate the vaccine will be licensed in India in 2026'', he added. "We plan to introduce the vaccine in both private and public sectors simultaneously. The initial conversation aligns with WHO guidelines for implementing public programs for the pediatric population. However, we are introducing the vaccine in the private sector for both pediatric and adult populations'", Wallace added. Qdenga is the company's first globally developed and marketed vaccine. It is a tetravalent live-attenuated vaccine targeting all four dengue serotypes, and has a two-dose regimen with a three-month interval. By Rupali Mukherjee ,

Vaccine

24 Oct 2024

·www.biopharmadive.com

Dengue is spreading and Sanofi is pulling the US market’s only vaccine. What’s next?

Derek Wallace was in a dengue-focused intensive care unmet in Thailand in 2009 when he first saw the devastating impact of the disease up close, also known as breakbone fever. Facing a shortage of space, children shared beds while parents slept together on mattresses tucked below.Thats been the case for decades in some countries, said Wallace, who was a clinical team leader for Sanofi's dengue vaccine studies at the time and is now president of Takeda Pharmaceuticals global vaccine business unit. But whats really important is that its getting worse. Theres 30 times more dengue than there was 50 years ago, and theres eight times more dengue now than there was 20 years ago.The mosquito-transmitted virus is among the top 10 global health threats designated by the World Health Organization. There were a record 6.43 million cases of dengue and nearly 7,000 deaths worldwide in 2023 the largest outbreak ever recorded. Dengue is also spreading faster in places where it hasnt before thanks to factors like climate change, urbanization and increased global travel, according to the WHO.Dengue is moving, and we are starting to get a ton of locally acquired dengue fever cases in the U.S., specifically in Puerto Rico, Virgin Islands and Florida, said Katelyn Jetelina, an epidemiologist and data scientist known for a popular newsletter. And we expect this to continue increasing over time.Despite the rapid global spread, there is no specific treatment for dengue, and worldwide vaccine availability is spottly.Sanofis Dengvaxia is currently the only dengue vaccine approved by the Food and Drug Administration in the U.S. But the company is discontinuing the shot in the third quarter of 2026 due to low global demand for this product, a Sanofi spokesperson said via email.Derek Wallace, president, global vaccine business unit, TakedaPermission granted by TakedaTakedas two-dose dengue vaccine, Qdenga, is approved in 40 countries outside of the U.S, and Takeda withdrew its U.S. application in 2023. Some additional data was requested that we couldn't provide, Wallace said, but declined to provide details.Although the U.S. IND is still open for Qdenga, there are no specific updates to share at this time about the timing of supplying additional data or resubmission, a Takeda spokesperson said via email.The vaccination challengeContracting most viral diseases for the first time will arm the body with antibodies that fend off subsequent infections. But thats not the case with dengue, thanks to antibody dependent enhancement that stems from dengues four closely related, but distinct, viral serotypes.Its challenging because it's a very unique disease in which secondary infections are more severe than the first infections, said Jetelina.Sanofis vaccine has long controversial for this reason. Receiving Dengvaxia could act as a first dengue infection, resulting in a more severe illness after contracting the virus a second time. As a result, Dengvaxia can only be administered to people whove had dengue before, and people must be screened for a previous infection before getting the shot.But thats not how Dengvaxias initial Philippines rollout went a mass vaccination program didnt take this screening step, leading to more severe disease among some patients and potentially some deaths.The onerous logistics of needing a pre-vaccine screening combined with a three-dose regimen not to mention erodeing public trust in vaccines has curbed demand for Dengvaxia so substantially that Sanofi is pulling it from the market.While we have made consistent efforts to facilitate its access and the implementation of the Screen & Vaccinate approach as recommended by WHO in 2018, uptake and demand has remained low, the Sanofi spokesperson said. Despite an increased prevalence of dengue in different parts of the world, theres only one Dengvaxia immunization program in place due to the complexity of implementing this product.Qdenga doesnt have these limitations. According to Takeda, the two-dose jab is the only vaccine approved for use regardless of previous dengue exposure. The WHO doesnt recommend pre-vaccination screenings for Qdenga administration in settings with high dengue transmission, although local approvals may vary. Qdenga has been shown to be 61% effective against symptomatic disease and 84% effective in preventing hospitalization. Still, its not approved in the U. S.Other vaccines are in development, including the single-dose ButantanDengue vaccine that showed positive Phase 3 study results.Dengues spreadThese vaccination and treatment challenges only make dengues spread more worrisome.Dengue is spreading to areas where it was not prevalent, and its affecting more susceptible populations that have no immunity whatsoever, said Andr Siqueira, head of the Dengue Global Program at the nonprofit Drugs for Neglected Diseases.He points to southern Brazil, where dengues recent and rapid spread has overwhelmed health systems in an area that previously didnt have any infections.What has happened the last few years in Brazil may mirror what can happen in these places where dengue transmission is still picking up, Siqueira said.The U. S. is one of those places. In Puerto Rico, a record-high dengue surge sparked a public health emergency in March, and in the Florida Keys, public health officials issued an alert last summer.Dengue thrives in warm urban areas, and the mosquitoes responsible for its spread can efficiently reproduce even in small pockets of water. Therefore, a warming climate with heavier rainfalls, along with increased urbanization, are all fueling the spread. Moreover, these mosquitoes have evolved resistance to insecticides and are adapting to different conditions, including more temperate climates, Siqueira said.Thats why public health organizations are taking action. DNDi kick-started its Dengue Alliance in 2022; the WHO launched a global strategic plan against dengue earlier this month; and Takeda partnered with the Indian pharma Biological E. Limited earlier this year to accelerate access to the vaccine in endemic areas.But public health officials and local health systems are still racing against the clock, calling for more vaccines, dengue-specific treatments and improved diagnostics.There is a perception that well find one solution for dengue, Siqueira said. What we probably need in the most affected areas is an integrated approach. '

Clinical ResultVaccineDrug ApprovalPhase 3

100 Deals associated with Dengue vaccine tetravalent(Takeda)

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Dengue	Indonesia	Takeda Pharmaceutical Co., Ltd.	22 Aug 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis A	Phase 3	United Kingdom	Takeda Pharmaceutical Co., Ltd.	16 May 2018
Yellow Fever	Phase 3	United States	Takeda Pharmaceutical Co., Ltd.	28 Feb 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03771963 (TAK-003, Pubmed \| Expert Rev Vaccines)	Phase 2/3	Pregnancy	557	TAK-003	nhafjkbtfv(ngbuinkuqe) = zrpbyukpsm ijegfkxqtd (dfpdllykrk ) View more	Positive	31 Dec 2025
				TAK-003 (Placebo)	nhafjkbtfv(ngbuinkuqe) = xpsfprkalx ijegfkxqtd (dfpdllykrk ) View more
NCT03999996 (CTgov)	Phase 3	Dengue	365	Dengue Tetravalent Vaccine+Live, Attenuated+Takeda (Prior to Booster: DEN-304)	rjhblsaayu(iwzecdthgv) = uzshvagwim mgvfjlnwgz (nouprshmvt, xgdshrvknv - rgwjqzopsi) View more	-	12 Jun 2025
				Dengue Tetravalent Vaccine+Live, Attenuated+Takeda (Prior to Booster: DEN-315)	rjhblsaayu(iwzecdthgv) = fhwxezhpye mgvfjlnwgz (nouprshmvt, rmzqhptwwm - fbkglxxotx) View more
NCT02747927 (DEN-301, Pubmed \| Clin Infect Dis)	Phase 3	Dengue	-	TAK-003 Vaccine	fvpnstnvyv(uragalpzlv) = GMTs remained elevated against all 4 serotypes for ∼4 years postvaccination, with no evident differences across age groups avmngkxzbb (vnpsxafvic )	Positive	05 Feb 2025
NCT02747927 (Pubmed \| J Infect Dis)	Phase 3	Dengue yellow fever vaccination	-	TAK-003	czktlgfbqu(xocoqimruu) = Within 28 days of any vaccination, the proportions of participants with serious adverse events in the YF/JE prior vaccination population were comparable between the TAK-003 and placebo groups uufaekwmjj (nuuteoffjj )	-	16 Dec 2024
NCT04313244 (CTgov)	Phase 3	Dengue	614	9vHPV Vaccine+Dengue Tetravalent Vaccine (TDV) (9vHPV+TDV)	qnjxhlfydz(jmnsnwotbo) = jzalwoblgw ujwfnhtyev (licmwqlzrq, xmrhhmilud - jsbyeqsmet) View more	-	07 Feb 2024
				9vHPV Vaccine (9vHPV)	qnjxhlfydz(jmnsnwotbo) = rivkwpvluo ujwfnhtyev (licmwqlzrq, nfulfsnssk - jdlnqezgkk) View more
NCT03342898 (Pubmed)	Phase 3	Dengue \| Yellow Fever	900	YF-17D+TAK-003	hbsiilbmby(ndrowaorvg) = koacwnhljq sufbraxran (mdectwudst )	-	01 Mar 2023
NCT03525119 (Pubmed)	Phase 3	Dengue	900	HAV vaccine	zgojxbwmoe(gzpznkwwpf) = qxaqvypphd hhbnupguks (ejfbphuprr ) View more	-	19 Jan 2023
				TAK-003	wpwjiyhlgt(rrnrogebbk) = cjkajgjljl lviunkoksf (ukifkayuth )
NCT03771963 (TAK-003, CTgov)	Phase 3	Dengue	200	Tetravalent Dengue Vaccine (TDV)	ldgkbgeljv(flpuczhymc) = hihcpyfdwo nvvbtudjhu (zdanfcxiwx, ydktbiyfqz - igykvbxgik) View more	-	07 Jun 2021
NCT03341637 (Pubmed \| Rev Panam Salud Publica)	Phase 3	-	400	TAK-003	rrizybcunu(ulhvlsrjxy) = One MAAE in each group was considered treatment-related (TAK-003: injection-site erythema, and placebo: pharyngitis) mhaddwglvh (ebzxuihvox )	-	01 Jan 2021
				Placebo
NCT03423173 (CTgov)	Phase 3	Dengue	923	Placebo (Placebo)	vnrdzpuwsq(lnnwbbpafa) = tbiscndvdv jngvnsxctt (poebcemeux, jdmratmteu - vqiwkdhsty) View more	-	20 Oct 2020
				TAK-003 (TDV Lot 1)	vnrdzpuwsq(lnnwbbpafa) = tdztxysxum jngvnsxctt (poebcemeux, zuygdffczm - wjbqegocqj) View more

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