NCT03423173 is a Phase 3 clinical trial of TAK-003 in Dengue Fever, sponsored by Takeda.

Who is sponsoring NCT03423173?

NCT03423173 is sponsored by Takeda.

What drugs are being tested in NCT03423173?

Interventions in NCT03423173: TAK-003, Placebo.

What condition does NCT03423173 study?

NCT03423173 studies Dengue Fever.

Is NCT03423173 still recruiting?

NCT03423173 is currently completed. Last updated 20 October 2020.

Are results published for NCT03423173?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-10-20 · How we verify

NCT03423173

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 20 October 2020

What this trial tests

Phase 3 trial testing TAK-003 in Dengue Fever in 923 participants. Completed in 14 January 2019.

Timeline

12 February 2018

Primary endpoint
3 August 2018

14 January 2019

Quick facts

Lead sponsor	Takeda
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	923
Start date	12 February 2018
Primary completion	3 August 2018
Estimated completion	14 January 2019
Sites	14 locations across United States

Drugs / interventions tested

TAK-003 — full drug profile →
Placebo

Conditions studied

Dengue Fever — all drugs for Dengue Fever →

Sponsor

Takeda — full company profile →

Who can join

Adults 18 to 60, any sex, with Dengue Fever. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

DENV-1

Group	Value	95% CI
Placebo	5.3	4.7 – 6.1
TDV Lot 1	202.9	155.9 – 264.1
TDV Lot 2	293.8	214.9 – 401.6
TDV Lot 3	322.1	238.1 – 435.9

DENV-2

Group	Value	95% CI
Placebo	6.3	4.8 – 8.2
TDV Lot 1	3090.3	2494.8 – 3828.0
TDV Lot 2	2386.0	1913.0 – 2976.1
TDV Lot 3	3574.1	3087.8 – 4137.0

DENV-3

Group	Value	95% CI
Placebo	5.4	4.6 – 6.3
TDV Lot 1	149.5	116.6 – 191.6
TDV Lot 2	117.3	92.7 – 148.4
TDV Lot 3	122.8	97.4 – 155.0

DENV-4

Group	Value	95% CI
Placebo	5.4	4.7 – 6.2
TDV Lot 1	116.3	93.8 – 144.2
TDV Lot 2	187.9	154.4 – 228.6
TDV Lot 3	115.8	94.0 – 142.5

Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset Secondary · 1 month post second dose (Day 120) and 6 months post second dose (Day 270)

Seropositivity was defined as a reciprocal neutralizing titer ≥ 10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.

DENV-1, Day 120

Group	Value	95% CI
Placebo	1.7	0.0 – 8.9
TDV Lot 1	97.5	92.9 – 99.5
TDV Lot 2	96.9	92.3 – 99.1
TDV Lot 3	99.2	95.4 – 100.0

DENV-2, Day 120

Group	Value	95% CI
Placebo	6.7	1.8 – 16.2
TDV Lot 1	99.2	95.4 – 100.0
TDV Lot 2	98.4	94.5 – 99.8
TDV Lot 3	100.0	96.9 – 100.0

DENV-3, Day 120

Group	Value	95% CI
Placebo	1.7	0.0 – 8.9
TDV Lot 1	97.5	92.9 – 99.5
TDV Lot 2	94.6	89.1 – 97.8
TDV Lot 3	98.3	94.0 – 99.8

DENV-4, Day 120

Group	Value	95% CI
Placebo	1.7	0.0 – 8.9
TDV Lot 1	97.5	92.9 – 99.5
TDV Lot 2	100.0	97.2 – 100.0
TDV Lot 3	97.5	92.7 – 99.5

DENV-1, Day 270

Group	Value	95% CI
Placebo	3.4	0.4 – 11.7
TDV Lot 1	97.3	92.3 – 99.4
TDV Lot 2	89.4	82.6 – 94.3
TDV Lot 3	95.8	90.5 – 98.6

DENV-2, Day 270

Group	Value	95% CI
Placebo	6.8	1.9 – 16.5
TDV Lot 1	100.0	96.7 – 100.0
TDV Lot 2	97.6	93.1 – 99.5
TDV Lot 3	99.2	95.4 – 100.0

DENV-3, Day 270

Group	Value	95% CI
Placebo	0	0.0 – 6.1
TDV Lot 1	95.5	89.8 – 98.5
TDV Lot 2	88.7	81.8 – 93.7
TDV Lot 3	92.5	86.2 – 96.5

DENV-4, Day 270

Group	Value	95% CI
Placebo	0	0.0 – 6.1
TDV Lot 1	92.8	86.3 – 96.8
TDV Lot 2	94.3	88.6 – 97.7
TDV Lot 3	91.7	85.2 – 95.9

GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset Secondary · 6 months post second dose (Day 270)

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.

DENV-1

Group	Value	95% CI
Placebo	5.4	4.9 – 5.9
TDV Lot 1	122.5	93.0 – 161.3
TDV Lot 2	136.7	95.2 – 196.3
TDV Lot 3	168.4	120.8 – 234.8

DENV-2

Group	Value	95% CI
Placebo	5.8	5.0 – 6.8
TDV Lot 1	1507.2	1242.3 – 1828.4
TDV Lot 2	1097.5	856.9 – 1405.5
TDV Lot 3	1693.3	1399.9 – 2048.3

DENV-3

Group	Value	95% CI
Placebo	NA	NA – NA
TDV Lot 1	88.0	69.2 – 111.9
TDV Lot 2	63.1	49.9 – 79.7
TDV Lot 3	71.6	57.3 – 89.5

DENV-4

Group	Value	95% CI
Placebo	NA	NA – NA
TDV Lot 1	64.1	49.5 – 83.1
TDV Lot 2	77.5	60.8 – 98.8
TDV Lot 3	51.2	40.0 – 65.5

Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination Secondary · Within 7 Days of each Vaccination (day of vaccination + 6 days)

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.

After Vaccination 1, Any Local AE

Group	Value	95% CI
Placebo	17.5
TDV Lot 1	51.0
TDV Lot 2	48.4
TDV Lot 3	50.0

After Vaccination 1, Pain-Any Severity

Group	Value	95% CI
Placebo	16.7
TDV Lot 1	45.5
TDV Lot 2	40.6
TDV Lot 3	41.7

After Vaccination 1, Pain-Mild

Group	Value	95% CI
Placebo	15.0
TDV Lot 1	39.9
TDV Lot 2	34.8
TDV Lot 3	37.7

After Vaccination 1, Pain-Moderate

Group	Value	95% CI
Placebo	1.7
TDV Lot 1	5.5
TDV Lot 2	5.1
TDV Lot 3	4.0

After Vaccination 1, Pain-Severe

Group	Value	95% CI
Placebo	0
TDV Lot 1	0
TDV Lot 2	0.8
TDV Lot 3	0

After Vaccination 1, Erythema-Any Severity

Group	Value	95% CI
Placebo	0.8
TDV Lot 1	25.7
TDV Lot 2	20.3
TDV Lot 3	23.0

After Vaccination 1, Erythema-Mild: 2.5-5(cm)

Group	Value	95% CI
Placebo	0
TDV Lot 1	23.7
TDV Lot 2	18.4
TDV Lot 3	21.8

After Vaccination 1,Erythema-Moderate: >5-<=10(cm)

Group	Value	95% CI
Placebo	0
TDV Lot 1	1.2
TDV Lot 2	2.0
TDV Lot 3	0.8

Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination Secondary · Within 14 Days of each Vaccination (day of vaccination + 13 days)

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. T

After Vaccination 1, Systemic AEs-Any

Group	Value	95% CI
Placebo	34.7
TDV Lot 1	43.3
TDV Lot 2	39.5
TDV Lot 3	42.9

After Vaccination 1, Headache-Any Severity

Group	Value	95% CI
Placebo	22.5
TDV Lot 1	28.9
TDV Lot 2	27.0
TDV Lot 3	28.6

After Vaccination 1, Headache-Mild

Group	Value	95% CI
Placebo	17.5
TDV Lot 1	21.3
TDV Lot 2	19.9
TDV Lot 3	21.4

After Vaccination 1, Headache-Moderate

Group	Value	95% CI
Placebo	4.2
TDV Lot 1	5.9
TDV Lot 2	5.5
TDV Lot 3	6.0

After Vaccination 1, Headache-Severe

Group	Value	95% CI
Placebo	0.8
TDV Lot 1	1.6
TDV Lot 2	1.6
TDV Lot 3	1.2

After Vaccination 1, Asthenia-Any Severity

Group	Value	95% CI
Placebo	9.2
TDV Lot 1	13.1
TDV Lot 2	15.2
TDV Lot 3	11.9

After Vaccination 1, Asthenia-Mild

Group	Value	95% CI
Placebo	7.5
TDV Lot 1	7.9
TDV Lot 2	9.4
TDV Lot 3	6.3

After Vaccination 1, Asthenia-Moderate

Group	Value	95% CI
Placebo	0.8
TDV Lot 1	3.6
TDV Lot 2	4.3
TDV Lot 3	4.8

Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination Secondary · Within 28 days (day of vaccination + 27 days) 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.

After First Vaccination

Group	Value	95% CI
Placebo	13.7
TDV Lot 1	18.6
TDV Lot 2	18.0
TDV Lot 3	16.7

After Second Vaccination

Group	Value	95% CI
Placebo	7.8
TDV Lot 1	10.5
TDV Lot 2	7.7
TDV Lot 3	6.6

Percentage of Participants With Serious Adverse Events (SAEs) Secondary · From the first vaccination on Day 1 until the end of the trial (Day 270)

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 round

Group	Value	95% CI
Placebo	3.1
TDV Lot 1	3.8
TDV Lot 2	1.1
TDV Lot 3	1.1

Percentage of Participants With Medically Attended Adverse Events (MAAEs) Secondary · From the first vaccination on Day 1 until the end of the trial (Day 270)

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.

Group	Value	95% CI
Placebo	13.7
TDV Lot 1	17.8
TDV Lot 2	12.3
TDV Lot 3	11.8

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 4/131 (3%)

Deaths: 1/131

TDV Lot 1

Serious: 10/264 (4%)

Deaths: 0/264

TDV Lot 2

Serious: 3/261 (1%)

Deaths: 0/261

TDV Lot 3

Serious: 3/263 (1%)

Deaths: 0/263

Serious adverse events (28 terms)

Reaction	System	Placebo	TDV Lot 1	TDV Lot 2	TDV Lot 3
Sciatica	Nervous system disorders	—	—	—	—
Rhegmatogenous retinal detachment	Eye disorders	—	—	—	—
Anastomotic ulcer perforation	Gastrointestinal disorders	—	—	—	—
Gastric ulcer	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Asthenia	General disorders	—	—	—	—
Perforation bile duct	Hepatobiliary disorders	—	—	—	—
Abdominal abscess	Infections and infestations	—	—	—	—
Infected seroma	Infections and infestations	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—
Chemical burn of gastrointestinal tract	Injury, poisoning and procedural complications	—	—	—	—
Concussion	Injury, poisoning and procedural complications	—	—	—	—
Femur fracture	Injury, poisoning and procedural complications	—	—	—	—
Stab wound	Injury, poisoning and procedural complications	—	—	—	—
Wound dehiscence	Injury, poisoning and procedural complications	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Lung squamous cell carcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Intracranial aneurysm	Nervous system disorders	—	—	—	—
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—	—	—	—
Major depression	Psychiatric disorders	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Placebo	TDV Lot 1	TDV Lot 2	TDV Lot 3
Injection site pruritus	General disorders	—	—	—	—
Injection site bruising	General disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—

Most-reported serious reactions: Sciatica, Rhegmatogenous retinal detachment, Anastomotic ulcer perforation, Gastric ulcer, Nausea, Vomiting, Asthenia, Perforation bile duct.

Data from ClinicalTrials.gov NCT03423173 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Three-year Efficacy and Safety of Takeda's Dengue Vaccine Candidate (TAK-003).
Rivera L, Biswal S, Sáez-Llorens X, Reynales H, et al · · 2022 · cited 176× · PMID 34606595 · DOI 10.1093/cid/ciab864
Clinical Safety Experience of TAK-003 for Dengue Fever: A New Tetravalent Live Attenuated Vaccine Candidate.
Patel SS, Rauscher M, Kudela M, Pang H. · · 2023 · cited 38× · PMID 35639602 · DOI 10.1093/cid/ciac418
An open-label, Phase 3 trial of TAK-003, a live attenuated dengue tetravalent vaccine, in healthy US adults: immunogenicity and safety when administered during the second half of a 24-month shelf-life.
Patel SS, Winkle P, Faccin A, Nordio F, et al · · 2023 · cited 25× · PMID 37846724 · DOI 10.1080/21645515.2023.2254964
Immunogenicity, Safety and Efficacy of the Dengue Vaccine TAK-003: A Meta-Analysis.
Flacco ME, Bianconi A, Cioni G, Cioni G, et al · · 2024 · cited 13× · PMID 39066408 · DOI 10.3390/vaccines12070770
Specificity and Breadth of the Neutralizing Antibody Response to a Live-Attenuated Tetravalent Dengue Vaccine.
DeMaso CR, Karwal L, Zahralban-Steele M, Dominguez D, et al · · 2022 · cited 11× · PMID 35771658 · DOI 10.1093/infdis/jiac272
Consistency of immunogenicity in three consecutive lots of a tetravalent dengue vaccine candidate (TAK-003): A randomized placebo-controlled trial in US adults.
Tricou V, Winkle PJ, Tharenos LM, Rauscher M, et al · · 2023 · cited 9× · PMID 37884415 · DOI 10.1016/j.vaccine.2023.09.049
Bridging the immunogenicity of a tetravalent dengue vaccine (TAK-003) from children and adolescents to adults.
LeFevre I, Bravo L, Folschweiller N, Medina EL, et al · · 2023 · cited 7× · PMID 37230978 · DOI 10.1038/s41541-023-00670-6
Pathogenesis and clinical management of arboviral diseases.
Cenci Dietrich V, Costa JMC, Oliveira MMGL, Aguiar CEO, et al · · 2025 · cited 6× · PMID 40134841 · DOI 10.5501/wjv.v14.i1.100489

Verify or expand the search:

Other recruiting trials for Dengue Fever

Currently open trials in the same condition.

NCT06579755 — A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years) · Phase 3 · recruiting
NCT07409857 — International Registry of Dengue Infection in Congenital Bleeding Disorders (DengueCBDR) · recruiting
NCT07047521 — A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults · Phase 3 · active not recruiting
NCT07007585 — Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection · recruiting
NCT06665035 — A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers · Phase 3 · recruiting

Other Takeda trials

Trials by the same sponsor.

NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras · not yet recruiting
NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03423173 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 20 October 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03423173.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing