NCT03341637 is a Phase 3 clinical trial of Tetravalent Dengue Vaccine (TDV) in Dengue, sponsored by Takeda.

Who is sponsoring NCT03341637?

NCT03341637 is sponsored by Takeda.

What drugs are being tested in NCT03341637?

Interventions in NCT03341637: Tetravalent Dengue Vaccine (TDV), Placebo.

Is NCT03341637 still recruiting?

NCT03341637 is currently completed. Last updated 15 August 2019.

Are results published for NCT03341637?

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

Last reviewed 2019-08-15 · How we verify

NCT03341637

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

Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) in Adolescents in Non-Endemic Area(s)

Completed Phase 3 Results posted Last updated 15 August 2019

What this trial tests

Phase 3 trial testing Tetravalent Dengue Vaccine (TDV) in Dengue in 400 participants. Completed in 26 January 2019.

Timeline

14 December 2017

Primary endpoint
26 January 2019

26 January 2019

Quick facts

Lead sponsor	Takeda
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	400
Start date	14 December 2017
Primary completion	26 January 2019
Estimated completion	26 January 2019
Sites	5 locations across Mexico

Drugs / interventions tested

Tetravalent Dengue Vaccine (TDV) — full drug profile →
Placebo

Conditions studied

Dengue — all drugs for Dengue →

Sponsor

Takeda — full company profile →

Who can join

Adults 12 to 17, any sex, with Dengue. 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 Primary · One month post second dose (Day 120)

GMTs of neutralizing antibodies were measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity is defined as reciprocal neutralizing titer ≥10.

DENV-1

Group	Value	95% CI
Placebo	5.3	4.7 – 5.8
Tetravalent Dengue Vaccine (TDV)	327.9	281.7 – 381.8

DENV-2

Group	Value	95% CI
Placebo	6.0	5.2 – 7.0
Tetravalent Dengue Vaccine (TDV)	1742.5	1522.6 – 1994.3

DENV-3

Group	Value	95% CI
Placebo	5.2	4.8 – 5.6
Tetravalent Dengue Vaccine (TDV)	119.5	106.4 – 134.2

DENV-4

Group	Value	95% CI
Placebo	5.1	4.9 – 5.2
Tetravalent Dengue Vaccine (TDV)	142.7	126.4 – 161.0

Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 Secondary · Six months post second dose (Day 270)

DENV-1

Group	Value	95% CI
Placebo	5.4	4.8 – 6.0
Tetravalent Dengue Vaccine (TDV)	134.7	114.5 – 158.5

DENV-2

Group	Value	95% CI
Placebo	5.2	4.8 – 5.5
Tetravalent Dengue Vaccine (TDV)	740.9	645.2 – 850.7

DENV-3

Group	Value	95% CI
Placebo	5.3	4.9 – 5.9
Tetravalent Dengue Vaccine (TDV)	45.8	40.7 – 51.5

DENV-4

Group	Value	95% CI
Placebo	5.0	NA – NA
Tetravalent Dengue Vaccine (TDV)	37.5	32.9 – 42.7

Seropositivity Rates for Each of the 4 Dengue Serotypes Secondary · One month and six months post second dose (Day 120 and Day 270)

Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.

Day 120 (Month 4): DENV-1

Group	Value	95% CI
Placebo	1.4	0.0 – 7.5
Tetravalent Dengue Vaccine (TDV)	100.0	98.5 – 100.0

Day 120 (Month 4): DENV-2

Group	Value	95% CI
Placebo	8.3	3.1 – 17.3
Tetravalent Dengue Vaccine (TDV)	100.0	98.5 – 100.0

Day 120 (Month 4): DENV-3

Group	Value	95% CI
Placebo	1.4	0.0 – 7.5
Tetravalent Dengue Vaccine (TDV)	100.0	98.5 – 100.0

Day 120 (Month 4): DENV-4

Group	Value	95% CI
Placebo	1.4	0.0 – 7.5
Tetravalent Dengue Vaccine (TDV)	99.6	97.7 – 100.0

Day 270 (Month 9): DENV-1

Group	Value	95% CI
Placebo	2.7	0.3 – 9.5
Tetravalent Dengue Vaccine (TDV)	98.4	96.0 – 99.6

Day 270 (Month 9): DENV-2

Group	Value	95% CI
Placebo	1.4	0.0 – 7.4
Tetravalent Dengue Vaccine (TDV)	99.6	97.8 – 100.0

Day 270 (Month 9): DENV-3

Group	Value	95% CI
Placebo	2.7	0.3 – 9.5
Tetravalent Dengue Vaccine (TDV)	92.1	88.1 – 95.1

Day 270 (Month 9): DENV-4

Group	Value	95% CI
Placebo	0	0.0 – 4.9
Tetravalent Dengue Vaccine (TDV)	89.4	84.9 – 92.9

Seropositivity Rates for Multiple (2, 3 or 4) Dengue Serotypes Secondary · One month and six months post second dose (Day 120 and Day 270)

Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10.

Day 120 (Month 4): At Least Bivalent

Group	Value	95% CI
Placebo	1.4	0.0 – 7.5
Tetravalent Dengue Vaccine (TDV)	100.0	98.5 – 100.0

Day 120 (Month 4): At Least Trivalent

Group	Value	95% CI
Placebo	1.4	0.0 – 7.5
Tetravalent Dengue Vaccine (TDV)	100.0	98.5 – 100.0

Day 120 (Month 4): Tetravalent

Group	Value	95% CI
Placebo	1.4	0.0 – 7.5
Tetravalent Dengue Vaccine (TDV)	99.6	97.7 – 100.0

Day 270 (Month 9): At Least Bivalent

Group	Value	95% CI
Placebo	0	0.0 – 4.9
Tetravalent Dengue Vaccine (TDV)	99.2	97.2 – 99.9

Day 270 (Month 9): At Least Trivalent

Group	Value	95% CI
Placebo	0	0.0 – 4.9
Tetravalent Dengue Vaccine (TDV)	94.5	90.9 – 97.0

Day 270 (Month 9): Tetravalent

Group	Value	95% CI
Placebo	0	0.0 – 4.9
Tetravalent Dengue Vaccine (TDV)	85.8	80.9 – 89.9

Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity Secondary · Within 7 days 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) (\<2.5 cm, mild: 2.5-5 cm, moderate: \>5 to \<=10 cm, severe: \>10 cm) and swelling (edema/induration) (\<2.5 cm, mild: 2.5-5 cm, moderate: \>5 to \<=10 cm, severe: \>10 cm).

After First Vaccination, Any Solicited Local AEs

Group	Value	95% CI
Placebo	34.3
Tetravalent Dengue Vaccine (TDV)	56.2

After First Vaccination, Pain:Mild

Group	Value	95% CI
Placebo	26.3
Tetravalent Dengue Vaccine (TDV)	44.8

After First Vaccination, Pain:Moderate

Group	Value	95% CI
Placebo	7.1
Tetravalent Dengue Vaccine (TDV)	9.7

After First Vaccination, Pain:Severe

Group	Value	95% CI
Placebo	1.0
Tetravalent Dengue Vaccine (TDV)	0.7

After First Vaccination, Erythema:Mild

Group	Value	95% CI
Placebo	0
Tetravalent Dengue Vaccine (TDV)	5.7

After First Vaccination, Swelling:Mild

Group	Value	95% CI
Placebo	0
Tetravalent Dengue Vaccine (TDV)	4.3

After Second Vaccination, Any Solicited Local AEs

Group	Value	95% CI
Placebo	30.9
Tetravalent Dengue Vaccine (TDV)	52.2

After Second Vaccination, Pain:Mild

Group	Value	95% CI
Placebo	24.5
Tetravalent Dengue Vaccine (TDV)	35.6

Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity Secondary · Within 14 days after each vaccination

Solicited systemic AEs were collected by participants using diary cards within 14 days after vaccination and included fever, headache, tiredness or weakness (asthenia), feeling of discomfort (malaise) and muscle pain (myalgia). Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activ

After First Vaccination: Any Solicited Systemic AE

Group	Value	95% CI
Placebo	58.6
Tetravalent Dengue Vaccine (TDV)	66.6

After First Vaccination: Headache-Mild

Group	Value	95% CI
Placebo	25.3
Tetravalent Dengue Vaccine (TDV)	31.4

After First Vaccination: Headache-Moderate

Group	Value	95% CI
Placebo	18.2
Tetravalent Dengue Vaccine (TDV)	10.4

After First Vaccination: Headache-Severe

Group	Value	95% CI
Placebo	1.0
Tetravalent Dengue Vaccine (TDV)	2.7

After First Vaccination: Asthenia-Mild

Group	Value	95% CI
Placebo	20.2
Tetravalent Dengue Vaccine (TDV)	24.7

After First Vaccination: Asthenia-Moderate

Group	Value	95% CI
Placebo	13.1
Tetravalent Dengue Vaccine (TDV)	7.7

After First Vaccination: Asthenia-Severe

Group	Value	95% CI
Placebo	2.0
Tetravalent Dengue Vaccine (TDV)	2.3

After First Vaccination: Malaise-Mild

Group	Value	95% CI
Placebo	20.2
Tetravalent Dengue Vaccine (TDV)	18.7

Percentage of Participants With Any Unsolicited Adverse Events (AEs) Following Each Vaccination Secondary · Within 28 days after each vaccination

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.

After First Vaccination

Group	Value	95% CI
Placebo	25.0
Tetravalent Dengue Vaccine (TDV)	30.0

After Second Vaccination

Group	Value	95% CI
Placebo	17.9
Tetravalent Dengue Vaccine (TDV)	23.2

Percentage of Participants With Medically Attended AEs (MAAEs) Throughout the Study Secondary · From first vaccination (Day 1) through end of study (Day 270)

MAAEs were defined as AEs leading to a medical visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria.

Group	Value	95% CI
Placebo	38.0
Tetravalent Dengue Vaccine (TDV)	47.3

Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study Secondary · From first vaccination (Day 1) through end of study (Day 270)

An SAE was defined as any untoward medical occurrence or effect that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.

Group	Value	95% CI
Placebo	2.0
Tetravalent Dengue Vaccine (TDV)	0.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Unsolicited AEs: Within 28 days after Vaccination; MAAEs and SAEs: From first vaccination (Day 1) through end of study (Day 270). Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 2/100 (2%)

Deaths: 0/100

Tetravalent Dengue Vaccine (TDV)

Serious: 1/300 (0%)

Deaths: 0/300

Serious adverse events (4 terms)

Reaction	System	Placebo	Tetravalent Dengue Vaccine…
Abdominal pain	Gastrointestinal disorders	—	—
Appendicitis	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Ankle fracture	Injury, poisoning and procedural complications	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	Placebo	Tetravalent Dengue Vaccine…
Viral upper respiratory tract infection	Infections and infestations	—	—
Nasopharyngitis	Infections and infestations	—	—
Viral pharyngitis	Infections and infestations	—	—
Pharyngitis	Infections and infestations	—	—
Pharyngitis bacterial	Infections and infestations	—	—
Upper respiratory tract infection bacterial	Infections and infestations	—	—
Syncope	Nervous system disorders	—	—
Gastroenteritis	Infections and infestations	—	—
Gastritis	Gastrointestinal disorders	—	—

Most-reported serious reactions: Abdominal pain, Appendicitis, Urinary tract infection, Ankle fracture.

Data from ClinicalTrials.gov NCT03341637 adverse events section.

Sponsor's own description

The purpose of this study was to describe the neutralizing antibody response against each dengue serotype at 1 month post second dose of TDV or placebo in dengue-naive adolescent participants.

Publications & conference data

7 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
Immunogenicity and safety of a tetravalent dengue vaccine in dengue-naïve adolescents in Mexico City.
Biswal S, Mendez Galvan JF, Macias Parra M, Galan-Herrera JF, et al · · 2021 · cited 16× · PMID 34131423 · DOI 10.26633/rpsp.2021.67
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
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
Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine.
Rauscher M, Youard Z, Faccin A, Patel SS, et al · · 2025 · cited 2× · PMID 40099800 · DOI 10.1080/14760584.2025.2480297
Dengue vaccine effectiveness and safety: a systematic analysis of recent clinical trial data.
Kant R, Singh A, Ali AB, Nagre S, et al · · 2025 · cited 1× · PMID 41287091 · DOI 10.1186/s12985-025-02937-x

Verify or expand the search:

Other trials of Tetravalent Dengue Vaccine (TDV)

Trials testing the same drug.

NCT07047521 — A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults · Phase 3 · active not recruiting
NCT03771963 — Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults · Phase 3 · completed
NCT02747927 — Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children · Phase 3 · completed

Other recruiting trials for Dengue

Currently open trials in the same condition.

NCT07501793 — Demographic Characteristics of TAK-003 Dengue Vaccine Recipients in Vietnam · active not recruiting
NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
NCT07007585 — Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection · recruiting
NCT06894901 — Impact of IIT-SIT on Dengue Clusters · NA · recruiting
NCT07158190 — Evaluation of T-cell Responses After Vaccination With the Attenuated Tetravalent Dengue Vaccine (Takeda). · active not 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 NCT03341637 (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: 15 August 2019

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/NCT03341637.

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