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 (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120Primary· One month post second dose (Day 120)
GMTs of neutralizing antibodies for each of the 4 dengue serotypes were 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
Tetravalent Dengue Vaccine (TDV)
557.4
417.0 – 744.9
DENV-2
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
2047.4
1739.7 – 2409.5
DENV-3
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
131.8
105.0 – 165.4
DENV-4
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
119.6
97.7 – 146.5
Seropositivity Rates for Each of the 4 Dengue Serotypes at Days 120 and 270Secondary· One month and six months post second dose (Days 120 and 270)
Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.
Day 120: DENV-1
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
99.2
95.9 – 100.0
Day 120: DENV-2
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
100.0
97.2 – 100.0
Day 120: DENV-3
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
97.7
93.5 – 99.5
Day 120: DENV-4
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
99.2
95.9 – 100.0
Day 270: DENV-1
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
97.0
92.5 – 99.2
Day 270: DENV-2
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
98.5
94.7 – 99.8
Day 270: DENV-3
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
85.7
78.6 – 91.2
Day 270: DENV-4
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
86.5
79.5 – 91.8
Seropositivity Rates for Multiple (2, 3, or 4) Dengue Serotypes at Days 120 and 270Secondary· One month and six months post second dose (Days 120 and 270)
Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10. The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity for multiple dengue serotypes was summarized in the following categories: tetravalent and at least trivalent.
Day 120: At Least Trivalent
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
99.2
95.9 – 100.0
Day 120: Tetravalent
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
97.0
92.4 – 99.2
Day 270: At Least Trivalent
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
91.0
84.8 – 95.3
Day 270: Tetravalent
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
78.9
71.0 – 85.5
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270Secondary· Six months post second dose (Day 270)
GMTs of neutralizing antibodies were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.
DENV-1
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
311.6
222.8 – 435.9
DENV-2
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
1170.6
953.9 – 1436.5
DENV-3
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
63.0
48.4 – 82.0
DENV-4
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
57.6
44.2 – 75.0
Percentage of Participants With Solicited Local (Injection Site) Reactions Following Each Vaccination by SeveritySecondary· Up to 7 days (Day of vaccination + 6 subsequent days) after each of the vaccination
Solicited local adverse events (AEs) \[at injection site\] were collected by participants using diary cards within 7 days after each vaccination and included injection site pain \[Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)\], injection site erythema \[Grade 0 (\<25 mm), 1 (25 - ≤ 50 mm), 2 (\>50 - ≤ 100 mm), 3 (\> 100 mm)\] and injection site swelling \[Grade 0 (\<25 mm), 1 (25 - ≤ 50 mm), 2 (\>50 - ≤ 100 mm), 3 (\> 100 mm)\]. The per
After First Vaccination, Any Solicited Local AEs
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
35.9
After First Vaccination, Pain: Any Severity
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
29.7
After First Vaccination, Pain: Mild
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
25.5
After First Vaccination, Pain: Moderate
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
3.6
After First Vaccination, Pain: Severe
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
0.5
After First Vaccination, Erythema: Any Severity
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
13.0
After First Vaccination, Erythema: Mild
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
12.0
After First Vaccination, Erythema: Moderate
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
1.0
Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination by SeveritySecondary· Up to 14 days (Day of vaccination + 13 subsequent days) after each vaccination
Solicited systemic AEs were collected by participants using diary cards within 14 days after each vaccination and included fever, headache, asthenia, malaise and myalgia. Severity grades were: Grade 0: none, Grade 1: mild (no interference with daily activity), Grade 2: moderate (interference with daily activity with or without treatment), Grade 3: severe (prevents normal daily activity with or without treatment). Fever is defined as body temperature greater than or equal to 38°C (100.4°F). Fever was excluded from the overall count as no severity grading was applied for it. The percentages were
After First Vaccination, Any Solicited Systemic Local AEs
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
42.2
After First Vaccination, Headache: Any Severity
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
30.2
After First Vaccination, Headache: Mild
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
22.9
After First Vaccination, Headache: Moderate
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
5.7
After First Vaccination, Headache: Severe
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
1.6
After First Vaccination, Myalgia: Any Severity
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
25.5
After First Vaccination, Myalgia: Mild
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
20.8
After First Vaccination, Myalgia: Moderate
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
3.1
Percentage of Participants With Any Unsolicited Adverse Events Following Each VaccinationSecondary· Up to 28 days after each vaccination (Day of vaccination + 27 subsequent days)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a study vaccine; it does not necessarily have to have a causal relationship with study vaccine administration.
After First Vaccination
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
11.5
After Second Vaccination
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
10.8
Percentage of Participants With Serious Adverse Events (SAEs)Secondary· From first vaccination (Day 1) through end of study (Day 270)
An SAE is 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, or is an important medical event which may require intervention to prevent the items listed above or may expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization.
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
2.5
Percentage of Participants With Medically Attended Adverse Events (MAAEs)Secondary· From first vaccination (Day 1) through end of study (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.
Group
Value
95% CI
Tetravalent Dengue Vaccine (TDV)
26.0
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 270). Other (Non-serious) adverse events: Up to 28 days after each vaccination (Day of vaccination + 27 subsequent days)..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate the safety and immune response of a naturally aged lot of tetravalent dengue vaccine (TDV) in healthy participants, aged 18 to 60 years, in non-endemic country(ies) for dengue.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07047521 — A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults
· Phase 3
· active not recruiting
NCT03341637 — Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) in Adolescents in Non-Endemic Area(s)
· Phase 3
· completed
NCT02747927 — Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
· Phase 3
· completed
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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: 7 June 2021
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/NCT03771963.