Dengue FeverPhase 3NCT03423173

Lot-to-lot Consistency of 3 Lots of Tetravalent Dengue Vaccine (TDV) in Non-endemic Country(Ies) for Dengue

A Phase 3 study testing TAK-003 in people with Dengue Fever, run by Takeda at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to investigate lot-to-lot consistency in terms of equivalence of the immune responses induced by 3 consecutive TDV lots in healthy participants aged 18 to 60 years in non-endemic country(ies) for dengue. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Dengue Fever
What is being tested?: TAK-003
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 923 participants
Where: 14 sitesUnited States
Study dates: 12 Feb 2018to 14 Jan 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Is 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.
Signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.

Who cannot join

Has an elevated oral temperature (≥38°C or 100.4°F) within 3 days of the intended date of vaccination.
Known hypersensitivity or allergy to any of the vaccine components (including excipients of the investigational vaccine or placebo).
Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome).
Known or suspected impairment/alteration of immune function, including:
Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (M0) (use of inhaled, intranasal, or topical corticosteroids is allowed)
Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥ 2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (M0).

Show all 17Show fewer

Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial.
Receipt of immunostimulants within 60 days prior to Day 1 (M0).
Hepatitis C virus infection.
Genetic immunodeficiency.
Has abnormalities of splenic or thymic function.
Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Has any serious chronic or progressive disease according to judgment of the Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
Has body mass index (BMI) greater than or equal to 35 kg/m^2 (= weight in kg/[height in meters^2]).
Has history of substance or alcohol abuse within the past 2 years.
Had previous and planned vaccination (during the trial conduct) against any flavivirus including dengue, yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne encephalitis.
Has a current or previous infection with a flavivirus such as dengue, Zika, YF, JE, West Nile (WN) fever, tick-borne encephalitis or Murray Valley encephalitis and participants with a history of prolonged (≥1 year) habitation in a dengue endemic area.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Anaheim Clinical Trials, LLC
Anaheim, California, 92805
Heartland Research Associates LLC - Augusta
Augusta, Kansas, 67010
Advanced Clinical Research
Boise, Idaho, 83704
Synexus Limited - Columbus
Columbus, Ohio, 43212
Synexus Limited- Council Bluffs
Council Bluffs, Iowa, 51503
Synexus Limited - Minneapolis
Edina, Minnesota, 55435
Optimal Research
Huntsville, Alabama, 35802
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104
Heartland Research Associates LLC
Park City, Kansas, 67219
Optimal Research
Peoria, Illinois, 61614
Optimal Research
Rockville, Maryland, 20850
Advanced Clinical Research
Salt Lake City, Utah, 84123
Synexus Limited - St. Louis
St Louis, Missouri, 63141
Advanced Clinical Research
West Jordan, Utah, 84088

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Demonstrate Lot-to-Lot Consistency of 3 Lots of a Tetravalent Dengue Vaccine Candidate in Healthy Adults in Non-Endemic Country(Ies) for Dengue

Read the detailed description

The vaccine tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). The primary objective of this trial is to investigate lot-to-lot consistency in terms of equivalence of the immune responses induced by 3 consecutive lots of TDV in healthy participants in non-endemic country(ies) for dengue.

The study will enroll approximately 924 healthy participants. Participants will be randomized in 2:2:2:1 to one of 4 trial groups to receive TDV (Lots 1, 2 or 3) or placebo:

TDV 0.5 mL subcutaneous injection OR
Placebo normal saline solution (0.9% NaCl) for injection.

In each trial group, all participants will receive 2 doses of TDV or placebo by subcutaneous injection on Days 1 (Month 0) and 90 (Month 3). Immunogenicity will be assessed in participants included in the immunogenicity subset (TDV groups: 176 participants each and placebo group: 88 participants) and safety will be assessed in all participants in each group.

This multi-center trial will be conducted in the United States. The overall time to participate in this study is 270 days. Participants will make multiple visits to the clinic including a final visit at Day 270.

Conditions: Dengue Fever
Being tested: TAK-003, Placebo
Keywords: Vaccine
Medical subject headings: Dengue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAK-003Biological
Also called TDV
TDV subcutaneous injection
PlaceboBiological
TDV Placebo-matching normal saline (0.9% NaCl) subcutaneous injection

Study groups in NCT03423173
Study group	Role	What they receive
Placebo	Placebo comparator	TDV placebo matching injection, subcutaneously (SC) once on Day 1, and Day 90. Receives: Biological: Placebo
TDV Lot 1	Experimental	Participants were administered TDV lot 1, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. Receives: Biological: TAK-003
TDV Lot 2	Experimental	Participants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. Receives: Biological: TAK-003
TDV Lot 3	Experimental	Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90. Receives: Biological: TAK-003

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset
GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes was measured by microneutralization test 50% [MNT50]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Measured: 1 month post second dose (Day 120)

Secondary outcomes (7)

Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset
Seropositivity was defined as a reciprocal neutralizing titer ≥ 10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Measured: 1 month post second dose (Day 120) and 6 months post second dose (Day 270)
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset
GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes was measured by microneutralization test 50% [MNT50]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Measured: 6 months post second dose (Day 270)
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination
Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), redness (erythema) (<25 mm, mild: >25 - ≤50 mm, moderate: >50 - ≤100 mm, severe: >100 mm) and swelling (edema/induration) (<25 mm, mild: >25 - ≤50 mm, moderate: >50 - ≤100 mm, severe: >100 mm ). The percentages were rounded off to the first decimal place.
Measured: Within 7 Days of each Vaccination (day of vaccination + 6 days)
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
Solicited systemic AEs include fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. Solicited systemic AEs (headache, asthenia, malaise and myalgia) was graded from 0 to 3 by severity; where 0=None, 1=Mild: No interference with daily activity, 2=Moderate: Interference with daily activity, 3=Severe: Prevents daily activity; A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it. The percentages were rounded off to the first decimal place.
Measured: Within 14 Days of each Vaccination (day of vaccination + 13 days)
Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration.
Measured: Within 28 days (day of vaccination + 27 days) after each vaccination
Percentage of Participants With Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event that may require intervention to prevent any of the above mentioned criteria and/or may expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. The percentages were rounded off to the first decimal place.
Measured: From the first vaccination on Day 1 until the end of the trial (Day 270)
Percentage of Participants With Medically Attended Adverse Events (MAAEs)
MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria. The percentages were rounded off to the first decimal place.
Measured: From the first vaccination on Day 1 until the end of the trial (Day 270)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Feb 201814 Jan 2019

First posted6 Feb 2018
Study start12 Feb 2018
Primary completion3 Aug 2018
Study completion14 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Dengue FeverStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 923 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03423173
Sponsor's protocol ID: DEN-304
Status last verified: Oct 2020
First submitted: 31 Jan 2018
Last updated: 20 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

Gottardo R, Dean H, Nascimento EJM, Tricou V, Sharma M. Beyond neutralization: A comprehensive framework for evaluating humoral immunity induced by a live-attenuated tetravalent dengue vaccine. Vaccine. 2026 Aug 13;88:128929. doi: 10.1016/j.vaccine.2026.128929. Epub 2026 Jul 21.
PubMed 42480195
Rauscher M, Youard Z, Faccin A, Patel SS, Pang H, Zent O. Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. Expert Rev Vaccines. 2025 Dec;24(1):221-229. doi: 10.1080/14760584.2025.2480297. Epub 2025 Mar 27.
PubMed 40099800
Tricou V, Winkle PJ, Tharenos LM, Rauscher M, Escudero I, Hoffman E, LeFevre I, Borkowski A, Wallace D. Consistency of immunogenicity in three consecutive lots of a tetravalent dengue vaccine candidate (TAK-003): A randomized placebo-controlled trial in US adults. Vaccine. 2023 Nov 13;41(47):6999-7006. doi: 10.1016/j.vaccine.2023.09.049. Epub 2023 Oct 24.
PubMed 37884415

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
Healthy
RecruitingPhase 1
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
Healthy Volunteers, Dengue
Active, not recruiting
A Controlled Human Infection Model of Dengue
Dengue
RecruitingPhase 2/3
Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
Dengue
RecruitingPhase 2
Adaptive Dengue Antiviral Platform Trial
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All Dengue Fever trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Demonstrate Lot-to-Lot Consistency of 3 Lots of a Tetravalent Dengue Vaccine Candidate in Healthy Adults in Non-Endemic Country(Ies) for Dengue
ClinicalTrials.gov ID: NCT03423173
Acronym / sponsor ID: DEN-304
Conditions: Dengue Fever
Keywords: Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 923 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 12 Feb 2018 (actual)
Primary completion: 3 Aug 2018 (actual)
Study completion: 14 Jan 2019 (actual)
First posted: 6 Feb 2018 (actual)
Results: Posted 20 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will enroll approximately 924 healthy participants. Participants will be randomized in 2:2:2:1 to one of 4 trial groups to receive TDV (Lots 1, 2 or 3) or placebo:

TDV 0.5 mL subcutaneous injection OR
Placebo normal saline solution (0.9% NaCl) for injection.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Biological: PlaceboTDV placebo matching injection, subcutaneously (SC) once on Day 1, and Day 90.
TDV Lot 1	Experimental	Biological: TAK-003Participants were administered TDV lot 1, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90.
TDV Lot 2	Experimental	Biological: TAK-003Participants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90.
TDV Lot 3	Experimental	Biological: TAK-003Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Is 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.
Signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.

Key exclusion criteria (17 listed)

Has an elevated oral temperature (≥38°C or 100.4°F) within 3 days of the intended date of vaccination.
Known hypersensitivity or allergy to any of the vaccine components (including excipients of the investigational vaccine or placebo).
Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome).
Known or suspected impairment/alteration of immune function, including:
Has abnormalities of splenic or thymic function.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAK-003Also: TDVTDV subcutaneous injection	Biological	TDV Lot 1, TDV Lot 2, TDV Lot 3
PlaceboTDV Placebo-matching normal saline (0.9% NaCl) subcutaneous injection	Biological	Placebo

Primary outcome

Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset
Time frame: 1 month post second dose (Day 120)
GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes was measured by microneutralization test 50% [MNT50]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.

7 secondary outcomes

Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset
Time frame: 1 month post second dose (Day 120) and 6 months post second dose (Day 270)
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset
Time frame: 6 months post second dose (Day 270)
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination
Time frame: Within 7 Days of each Vaccination (day of vaccination + 6 days)
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
Time frame: Within 14 Days of each Vaccination (day of vaccination + 13 days)
Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination
Time frame: Within 28 days (day of vaccination + 27 days) after each vaccination
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: From the first vaccination on Day 1 until the end of the trial (Day 270)
Percentage of Participants With Medically Attended Adverse Events (MAAEs)
Time frame: From the first vaccination on Day 1 until the end of the trial (Day 270)

Results and safety

Results posted to the registry on 20 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	132	113
TDV Lot 1	263	228
TDV Lot 2	264	237
TDV Lot 3	264	234

Primary outcome: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset

Time frame: 1 month post second dose (Day 120). Geometric mean (95% Confidence Interval). Unit: titer

Measure	Placebo n = 60	TDV Lot 1 n = 120	TDV Lot 2 n = 129	TDV Lot 3 n = 118
DENV-1	5.3 (4.7 to 6.1)	202.9 (155.9 to 264.1)	293.8 (214.9 to 401.6)	322.1 (238.1 to 435.9)
DENV-2	6.3 (4.8 to 8.2)	3090.3 (2494.8 to 3828.0)	2386.0 (1913.0 to 2976.1)	3574.1 (3087.8 to 4137.0)
DENV-3	5.4 (4.6 to 6.3)	149.5 (116.6 to 191.6)	117.3 (92.7 to 148.4)	122.8 (97.4 to 155.0)
DENV-4	5.4 (4.7 to 6.2)	116.3 (93.8 to 144.2)	187.9 (154.4 to 228.6)	115.8 (94.0 to 142.5)

TDV Lot 1 vs TDV Lot 2: Geometric Mean Titer (GMT) Ratio: 0.69 (95% CI 0.46 to 1.04)
TDV Lot 2 vs TDV Lot 3: GMT Ratio: 0.91 (95% CI 0.60 to 1.38)
TDV Lot 1 vs TDV Lot 3: GMT Ratio: 0.63 (95% CI 0.41 to 0.96)

Population analysed: Per protocol Set (PPS) included all DENV-naïve participants in immunogenicity subset who received at least 1 dose of trial vaccine, with data available for Baseline (Day 1) and at least 1 post-Baseline immunogenicity measurement and had no major protocol violations.Number of participants analyzed:participants with data available at given timepoint.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 131 (3.1%)	4 of 131 (3.1%)	1 of 131
TDV Lot 1	10 of 264 (3.8%)	16 of 264 (6.1%)	0 of 264
TDV Lot 2	3 of 261 (1.1%)	26 of 261 (10%)	0 of 261
TDV Lot 3	3 of 263 (1.1%)	23 of 263 (8.7%)	0 of 263

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42480195Gottardo R, Dean H, Nascimento EJM, Tricou V, Sharma M. Beyond neutralization: A comprehensive framework for evaluating humoral immunity induced by a live-attenuated tetravalent dengue vaccine. Vaccine. 2026 Aug 13;88:128929. doi: 10.1016/j.vaccine.2026.128929. Epub 2026 Jul 21.
Derived from this study: PubMed 40099800Rauscher M, Youard Z, Faccin A, Patel SS, Pang H, Zent O. Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. Expert Rev Vaccines. 2025 Dec;24(1):221-229. doi: 10.1080/14760584.2025.2480297. Epub 2025 Mar 27.
Derived from this study: PubMed 37884415Tricou V, Winkle PJ, Tharenos LM, Rauscher M, Escudero I, Hoffman E, LeFevre I, Borkowski A, Wallace D. Consistency of immunogenicity in three consecutive lots of a tetravalent dengue vaccine candidate (TAK-003): A randomized placebo-controlled trial in US adults. Vaccine. 2023 Nov 13;41(47):6999-7006. doi: 10.1016/j.vaccine.2023.09.049. Epub 2023 Oct 24.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Related trials for Dengue Fever

Active, not recruitingPhase 3
A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director Clinical Science study director

Takeda

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAK-003 in people with Dengue Fever, run by Takeda at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset (time frame: 1 month post second dose (Day 120)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03423173, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.