Business Wire

Takeda Completes Enrollment of More Than 20,000 Children and Adolescents in Global Phase 3 Trial of Dengue Vaccine Candidate


Takeda Pharmaceutical Company Limited [TSE: 4502], (“Takeda”) today announced that it has completed enrollment of 20,100 children and adolescents ages 4 through 16 in its global, pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial, a double-blind, randomized and placebo-controlled study designed to evaluate the efficacy, safety and immunogenicity of its live-attenuated tetravalent dengue vaccine candidate (TAK-003).1 Takeda initiated the TIDES trial, the largest vaccine clinical trial for Takeda to date, in September 2016 and completed enrollment in less than seven months.1

“The successful enrollment of more than 20,000 children and adolescents in this Phase 3 trial, across several continents, and on an ambitious timeline, while maintaining a clear focus on quality and subject safety, reflects Takeda’s prioritization of dengue and the substantial capabilities of our global organization,” said Rajeev Venkayya, MD, President of the Global Vaccine Business Unit at Takeda.

The study is taking place in eight dengue-endemic countries in Latin America and Asia: Brazil, Colombia, Panama, Dominican Republic, Nicaragua, Philippines, Thailand and Sri Lanka.1 While dengue can affect people of all ages, it is a leading cause of serious illness among children in some countries in Latin America and Asia.2 The enrollment of children and adolescents between the ages of 4 and 16 years underscores the significant burden of dengue disease across the entire pediatric age range. Initial results of the TIDES trial are expected in 2018.1

TIDES will build on previous studies which have assessed the tolerability, safety and immunogenicity of the vaccine against all four dengue serotypes in multiple age groups to determine whether the vaccine helps prevent symptomatic dengue.3,4,5,6,7 In Phase 1 and Phase 2 studies, Takeda’s vaccine candidate induced neutralizing antibody responses against all four dengue virus serotypes across age groups and in both seropositive and seronegative individuals with no observed safety concerns.3,4,5,6,7 Interim results of one Phase 2 study (DEN-203) showed the vaccine to be generally safe and well tolerated.3,5 Results also showed that adults vaccinated with two doses had a sustained immune response against all four serotypes of the dengue virus, even after two years.5 Interim results of another Phase 2 study (DEN-204) showed an acceptable safety profile in endemic pediatric populations, as well as antibody responses against the four dengue serotypes in dengue seropositive and seronegative participants, with a sustained immune response through 180 days.6,7

“This enrollment milestone demonstrates our commitment to a thorough evaluation of the safety and efficacy of our vaccine candidates and, subject to licensure, ensuring that they are available to all populations at risk. It follows Takeda’s recent decision to invest more than 100 million euros to build a new plant for the manufacturing of TAK-003,” said Venkayya. “Beyond dengue, Takeda is pursuing a number of vaccine programs to address high-priority infectious diseases including our Zika program funded by the U.S. Government’s Biomedical Advanced Research and Development Authority (BARDA) and our polio program supported by the Bill & Melinda Gates Foundation.”

About the Phase 3 TIDES Study 1

TIDES is investigating the efficacy, safety and immunogenicity of two doses of TAK-003 administered three months apart. TIDES participants were randomized to receive a two-dose regimen of either TAK-003 or placebo by subcutaneous injection at Day 1 and Day 90. A subset of these participants was randomly selected and stratified by region and age to be included in the safety and immunogenicity subsets. Efficacy assessments will take place once 120 cases of virologically confirmed dengue have accrued and after a minimum subject follow-up period of 12 months, post second vaccination.

The primary outcome measure is vaccine protection against virologically-confirmed dengue of any severity, caused by any of the four dengue virus serotypes, regardless of whether a subject has been previously exposed to dengue. Secondary endpoints include vaccine efficacy in preventing dengue induced by each dengue serotype, vaccine efficacy in preventing hospitalization due to dengue induced by any serotype, vaccine efficacy in preventing severe dengue induced by any serotype, frequency and severity of Adverse Events (AEs) or Serious Adverse Events (SAEs), and seropositivity rate and geometric mean titers (GMTs) of neutralizing antibodies in the immunogenicity subset.

About TAK-003

Takeda’s tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus (DENV-2), which provides the genetic ‘backbone’ for all four vaccine viruses.8 Phase 1 and 2 data have supported progression into Phase 3 study, suggesting that TAK-003 is safe and well-tolerated in children and adolescents (no vaccine-related SAEs occurred and reactogenicity was limited) and induced immunogenicity against all four dengue serotypes, even in seronegative participants.4,5,6,7

About Dengue

Dengue is the fastest spreading mosquito-borne viral disease.2 Dengue is spread by Aedes aegypti and Aedes albopictus mosquitoes and is caused by four dengue virus serotypes, each of which can cause dengue fever or severe dengue.9,10 The serotypes vary across different geographies, countries, regions, seasons and over time.11,12

Dengue outbreaks are observed in tropical and sub-tropical areas and have recently caused outbreaks in parts of mainland U.S. and Europe.9,13,14 Forty percent of the world now lives under the threat of dengue, which is responsible for approximately 390 million infections and 20,000 deaths globally each year.9,10 Dengue virus can infect people of all ages and is a leading cause of serious illness among children in some countries in Latin America and Asia.2

Takeda’s Commitment to Vaccines

Vaccines prevent more than two million deaths each year and have transformed global public health.15 For 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda’s global vaccine business is applying innovation to tackle some of the world’s most challenging infectious diseases, such as dengue, Zika, norovirus and polio. Our team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world’s most pressing public health needs.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit

1 Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES). 2016. Retrieved March 2017.

2 World Health Organization. Vector-borne Diseases: Dengue. 2015. Retrieved January 2017.

3 Osorio, J.E., et al. Development of a Recombinant, Chimeric Tetravalent Dengue Vaccine Candidate. Vaccine. 2015. Retrieved March 2017.

4 Osorio, J.E., et al. Safety and immunogenicity of a recombinant live attenuated tetravalent dengue vaccine (DENVax) in flavivirus-naive healthy adults in Colombia: a randomised, placebo-controlled, phase 1 study. The Lancet Infectious Diseases. 2014. Retrieved May 2016.

5 Wallace, D. Persistence of neutralizing antibodies one year after two doses of a candidate recombinant tetravalent dengue vaccine in subjects aged from 1.5 to 45 years. Presented at 6th Annual Meeting, American Society of Tropical Medicine and Hygiene. 2015.

6 Saez-Llorens X., et al. Phase II, double-blind, controlled trial to assess the safety and immunogenicity of different schedules of Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) in healthy subjects aged between 2 and <18 years and living in dengue endemic countries in Asia and Latin America. Presented at 5th Pan-American Dengue Research Network Meeting. 2016.

7 Sáez-Llorens, X., et al. Safety and immunogenicity of one versus two doses of Takeda's tetravalent dengue vaccine: Interim results of a long-term phase 2, randomized, placebo-controlled pediatric trial in Asia and Latin America. The Lancet Infectious Diseases. 2017. Retrieved March 2017.

8 Huang, C. Y.-H., et al. Genetic and Phenotypic Characterization of Manufacturing Seeds for Tetravalent Dengue Vaccine (DENVax). PLoS Neglected Tropical Diseases. 2013. Retrieved May 2016.

9 World Health Organization. Dengue and Severe Dengue. 2016. Retrieved January 2017.

10 Centers for Disease Control and Prevention. Clinical Guidance Dengue Virus. 2014. Retrieved January 2017.

11 Bravo, L., et al. Epidemiology of Dengue Disease in the Philippines (2000-2011): A Systematic Literature Review. PLoS Neglected Tropical Diseases. 2014. Retrieved January 2017.

12 Guzman, M.G., et al. Dengue: a continuing global threat. Nature reviews Microbiology. 2010. Retrieved May 2016.

13 Knowlton, K., et al. NRDC Issue Paper: Mosquito-Borne Dengue Fever Threat Spreading in the Americas. 2009. Retrieved May 2016.

14 Chan E., et al. Using Web Search Query Data to Monitor Dengue Epidemics: A New Model for Neglected Tropical Disease Surveillance. PLoS Neglected Tropical Diseases. 2011. Retrieved January 2017.

15 UNICEF. Immunization Facts and Figures. 2013. Retrieved January 2017.

Contact information

Takeda Pharmaceutical Company Limited
For media outside of Japan:
Elissa J. Johnsen
TEL: + 1 224-554-3185
For Japanese media:
Tsuyoshi Tada
TEL: +81-3-3278-2417

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

LIAF: Experts at the European Parlament - E-Cigarettes Are a Potential Game Changer for European Health20.3.2018 18:27Pressemelding

The following is a statement from LIAF – Lega Italiana Anti Fumo: The panel discussion at the EU Parliament recognises the potential benefits of electronic cigarettes and for European countries to treat these products as regular consumer products to ensure equal access for all Europeans. Following a debate in which leading scientific experts presented the state-of-the-art evidence around e-cigarettes, it became clear that public health is increasingly moving on from an approach that solely advocates ‘quit-or-die’ to a harm reduction strategy. “I’m glad to have brought the Parliament attention to this important issue for public health. Today we have listened to the results of scientific studies and researches from a high-level expert’s roundtable, which have illustrated to us the advantages of electronic cigarettes and the potential public health benefits that these products pose when compared to the conventional cigarettes. As decision-makers, we need to take into considerations these

Morinaga Milk's New Probiotic Strain, Bifidobacterium breve A1, May Prevent Onset of Alzheimer's Disease20.3.2018 18:00Pressemelding

Morinaga Milk Industry Co., Ltd. (TOKYO:2264), a leading Japanese dairy product company, today announced the results of a new study investigating the preventive effects of its new probiotic strain Bifidobacterium breve A1 on a model of Alzheimer’s disease. Researchers found that B. breve A1 improved spatial recognition capability, as well as learning and memory capabilities, in cognitively deficient mice, indicating it could play an important role in preventing the onset of Alzheimer’s Disease in humans.1 This press release features multimedia. View the full release here: (Fig. 1) Effects of B. Breve A1 in improving spatial recognition, learning and memory capabilities (Graphic: Business Wire) The number of patients affected by dementia is increasing worldwide. One report estimates there were 46.8 million people worldwide living with dementia in 2015 and projects this number will reach 131.5 million by 2050.2 Alzheimer’s disease

Dubai Breaks Ground on World’s Biggest CSP Project20.3.2018 16:10Pressemelding

HH Sheikh Mohammed bin Rashid Al Maktoum, Vice President and Prime Minister of the UAE and Ruler of Dubai, broke ground on the 4th phase of the Mohammed bin Rashid Al Maktoum Solar Park. This is the biggest Concentrated Solar Power (CSP) investment project in the world, based on the Independent Power Producer (IPP) model, and will generate 700MW on a single site. It will have the world’s tallest solar tower at 260 metres, and the largest thermal energy storage capacity in the world. It will provide clean energy to 270,000 residences, reducing 1.4 million tonnes of carbon emissions annually. The project will use two technologies: a 600MW parabolic basin complex and a 100MW solar tower, over 43 square kilometres. This project, with AED14.2 billion in investments, achieved the lowest Levelised Cost of Electricity (LCOE) of USD 7.3 cents per kW/h. This press release features multimedia. View the full release here: Dubai breaks groun

Edgecore Networks Introduces 400G Open Networking20.3.2018 16:00Pressemelding

OCP Summit – Edgecore Networks, the leader in open networking, today announced its contribution to the Open Compute Project (OCP) of the design of a 400 Gigabit Ethernet (400G) data center switch, the industry’s first 400G open design, that will enable public and private network operators to increase dramatically the capacity of their infrastructures. “Four years ago, Edgecore contributed the industry’s first OCP-ACCEPTED™ network product, a 10G top-of-rack switch,” said George Tchaparian, CEO, Edgecore Networks. “Since then, we have contributed over 15 network product designs as open networking technology and deployments grew to include 25G/100G data center fabrics, deep-buffer data center interconnect switches, service provider access infrastructures, open modular chassis, and campus/branch/wireless networks. Now, Edgecore is introducing the industry’s first 400G open network switch, enabling network operators to respond to growing demands for network capacity, and increasing the ban

Technics Organizes World's First Full Turntable Orchestra20.3.2018 14:48Pressemelding

On March 20, 2018, the "Record Day," Panasonic Corporation released the video of the world's first full orchestra performance featuring Technics "turntables (analog record players)" as the only instruments, under the Technics brand's theme, "Rediscover Music." This press release features multimedia. View the full release here: World's First Full Turntable Orchestra organized by Technics (Photo: Business Wire) Videos: - THE PHILHARMONIC TURNTABLE ORCHESTRA - BEHIND THE BEATS : THE PHILHARMONIC TURNTABLE ORCHESTRA "The Philharmonic Turntable Orchestra" special website Thirty renowned DJs from around the world, including DJ Rena, the reigning Japanese world champion (youngest ever world champion in history), who took the "DMC World Championship" title in 2017 at just 12 years old*, came together to create the world's first "turntable orchestra." Using the Technics' iconic tu

Bentley Systems' Year in Infrastructure 2018 Conference and Awards Gala to be Held in London, Oct. 15-1820.3.2018 14:30Pressemelding

Bentley Systems, Incorporated, a leading global provider of comprehensive software solutions for advancing infrastructure, today announced that the Year in Infrastructure 2018 Conference will be held Oct. 15 through 18 in London at the Hilton London Metropole. Presented by Bentley Institute, the conference is a global gathering of leading industry executives and prominent thought leaders in the design, construction, and operations of the world’s infrastructure. The theme of this year’s conference is Going Digital: Advancements in Infrastructure. The conference features nearly 70 speakers and more than 50 informative sessions, including keynotes by leading industry experts, interactive workshops, forums, panel discussions, and product demonstrations. Attendees can visit the Technology Pavilion, which features exhibits and presentations from Bentley Systems and its strategic partners Microsoft, Siemens, Topcon, and Bureau Veritas. On the first day of the conference, Bentley Institute wil