Recent Updates
Recently added Catalysts

TDV

Phase 3

Dengue Fever | Monoclonal antibody | Infectious Disease |Takeda Pharmaceutical Company Limited|Last Updated: Apr 29, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials5
Total Enrollment1,309
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06579755A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years)PHASE3 RECRUITING 800Jan 20, 2026Apr 14, 2027Apr 29, 20267 Argentina, Brazil +2
NCT06665035A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and ToddlersPHASE3 RECRUITING 212Jun 16, 2025Mar 3, 2030Jul 15, 20254 Colombia, Thailand
NCT06741683A Study of Dengue Tetravalent Vaccine (TDV) in Healthy Participants in JapanPHASE2 COMPLETED 187Jan 31, 2025Dec 17, 2025Dec 30, 20255 Japan
NCT03746015Immunogenicity and Safety of Tetravalent Dengue Vaccine Candidate (TDV) in Flavivirus-Naïve and Dengue-Immune AdultsPHASE2 COMPLETED 30Dec 28, 2018Mar 1, 2021Sep 8, 20252 United States
NCT01728792Impact of SC vs IM Administration of DENVax (TDV) on Safety and ImmunogenicityPHASE1 COMPLETED 80Jan 22, 2013Nov 21, 2013Jul 18, 20191 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1
Within 7 days post-vaccination at Day 1

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medical product (IMP); it does not necessarily have to have a causal relationship with IMP administration. Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration.

Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 90
Within 7 days post-vaccination at Day 90

Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration.

Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1
Within 14 days post-vaccination at Day 1

Solicited systemic AEs include fever (body temperature greater than or equal to \[\>=\] 38 degree Celsius \[C\], asthenia, malaise, headache, and myalgia.

Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 90
Within 14 days post-vaccination at Day 90

Solicited systemic AEs include fever (body temperature \>= 38 degree (C), asthenia, malaise, headache, and myalgia.

Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 Days Post Vaccination at Day 1
Within 7 days post-vaccination at Day 1

Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.

Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 Days Post Vaccination at Day 90
Within 7 days post-vaccination at Day 90

Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.

Percentage of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 1
Within 14 days post-vaccination at Day 1

Solicited systemic AEs include fever (body temperature \>= 38 degree (C), asthenia, malaise, headache, and myalgia. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.

Percentage of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 90
Within 14 days post-vaccination at Day 90

Solicited systemic AEs include fever (body temperature \>= 38 degree (C), asthenia, malaise, headache, and myalgia. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.

Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 1
Within 28 days post-vaccination at Day 1

An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day IMP administration).

Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 90
Within 28 days post-vaccination at Day 90

An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day of IMP administration).

Percentage of Participants with a Serious Adverse Event (SAE)
From first vaccination on Day 1 through the end of trial (up to 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, is an important medical event.

Geometric Mean Titers (GMTs) of Neutralizing Antibodies by Microneutralization Test (MNT) for Each of the 4 Dengue Virus Serotypes at Day 120
At Day 120

GMTs of neutralizing antibodies will be measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes in all participants. The 4 dengue virus serotypes are dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4.

Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1 (Overall and by Severity)
Within 7 Days post-vaccination at Day 1

Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.

Percentage of Participants with Solicited Local (Injection Site) AEs Within 7 Days Post Vaccination at Day 90 (Overall and by Severity)
Within 7 days post-vaccination at Day 90

Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.

Percentage of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1 (Overall and by Severity)
Within 14 days post-vaccination at Day 1

Solicited systemic AEs include fever (body temperature greater than or equal to \[\>=\] 38-degree Celsius \[C\], drowsiness, irritability/fussiness and loss of appetite. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.

Percentage of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 90 (Overall and by Severity)
Within 14 days post-vaccination at Day 90

Solicited systemic AEs include fever (body temperature \>= 38 degree (C), drowsiness, irritability/fussiness and loss of appetite. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.

Percentage of Participants with Unsolicited AEs Within 28 Days Post Vaccination at Day 1
Within 28 days post-vaccination at Day 1

An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day IMP administration).

Percentage of Participants with Unsolicited AEs Within 28 Days Post Vaccination at Day 90
Within 28 days post-vaccination at Day 90

An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day of IMP administration).

Percentage of Participants with Medically-attended AEs (MAAEs)
From Day 1 through the end of trial (up to Day 1170)

MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department (medically attended visits), but not fulfilling seriousness criteria.

Percentage of Participants with Serious Adverse Events (SAEs)
From Day 1 through the end of trial (up to Day 1170)

SAE is any untoward medical occurrence or effect that at any dose 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.

Geometric Mean Titers (GMTs) of Neutralizing Antibodies by Microneutralization Test (MNT) for Each of 4 Dengue Virus Serotypes at Day 120
Day 120

GMTs of neutralizing antibodies will be measured by MNT against 4 dengue virus serotypes. The 4 dengue virus serotypes are dengue virus (DENV-1, DENV-2, DENV-3 and DENV-4) will be reported.

Percentage of Seropositive Participants for Each of the 4 Dengue Virus Serotypes on Day 120
Day 120

Seropositivity is defined as a reciprocal neutralizing titer greater than or equal to (\>=) 10. The 4 dengue virus serotypes (DENV) are DENV-1, DENV-2, DENV-3 and DENV-4.

Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 15
Day 15

GMT of neutralizing antibodies were measured for each of the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by microneutralization test 50% (MNT50).

GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 30 (Month 1)
Day 30 (Month 1)

GMT of neutralizing antibodies were measured for each of the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.

GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 60 (Month 2)
Day 60 (Month 2)

GMT of neutralizing antibodies were measured for each of the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.

GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 90 (Month 3)
Day 90 (Month 3)

GMT of neutralizing antibodies were measured for each of the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.

GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 105
Day 105

GMT of neutralizing antibodies were measured for each of the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.

GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 120 (Month 4)
Day 120 (Month 4)

GMT of neutralizing antibodies were measured for each of the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.

GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 150 (Month 5)
Day 150 (Month 5)

GMT of neutralizing antibodies were measured for each of the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.

GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 180 (Month 6)
Day 180 (Month 6)

GMT of neutralizing antibodies were measured for each of the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.

GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 270 (Month 9)
Day 270 (Month 9)

GMT of neutralizing antibodies were measured for each of the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.

GMT of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 360 (Month 12)
Day 360 (Month 12)

GMT of neutralizing antibodies were measured for each of the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.

Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator
For 14 days after each vaccination (Up to Day 14 and/or Day 104)

Injection site reactions were evaluated by the investigator within 14 days following each injection. Erythema (redness), edema (swelling/induration) and pain were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Pain was graded from 0=None to 4=Life-threatening. Erythema and Edema longest diameter were graded using the scale: 0=\<2.5 centimeters (cm) to 3=Severe: \>10 cm. Itching was graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where: Grade 0=no itching to Grade 3=severe. Injection site reactions are presented as the number of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.

Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
For 14 days after each vaccination (Up to Day 14 and/or Day 104)

Injection site reactions were recorded by the participant in a memory aid for 14 days following each injection. Participants measured and recorded the longest diameter of redness (erythema) or swelling (edema) using the scale: 0=\< 2.5 cm to 3= Severe: \> 10 cm. For pain and itching they recorded intensity grade: 0=not present, 1=mild, 2=moderate or 3=severe. Participant-recorded local reactions are presented as number of participants reporting a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only those score categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.

Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
For 14 days after each vaccination (Up to Day 14 and/or Day 104)

Solicited systemic AEs were recorded by the participant into a memory aid for 14 days following each vaccination. Solicited systemic AEs included: headache, muscle pain (myalgia), joint pain (arthralgia), eye pain, sensitivity to light (photophobia), tiredness (fatigue), body rash, nausea and vomiting. Systemic AEs were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial where: Grade 0=none to Grade 4=severe. A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded in the memory aid. Solicited systemic AEs are presented as the number of participants reporting the event, by, AE, overall and by severity, using the participant's worst reported severity grade. Group 3 participants received 2 doses 90 days apart; systemic AEs following either vaccination are combined.

Number of Participants With at Least 1 Unsolicited Related Adverse Event Following Either Vaccine Dose
For 30 days after each vaccination for non-serious AEs and through the end of the study for SAEs (Up to 120 Days)

An Adverse Event (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. The investigator assessed whether the AE was related to the study vaccination.

Number of Participants With at Least 1 Serious Adverse Event During the Study
First Vaccination to End of Study (Up to Day 120)

An Adverse Event (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. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

Seroconversion Rate to Each of Four Dengue Serotypes
Approximately 28 to 30 days after each vaccination (Up to Day 30 and/or Day 104)

Seroconversion rate was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plaques (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.

Secondary Endpoints
Number of Participants with Solicited Local (Injection Site) AEs Within 7 Days Post Vaccination at Day 1 and Day 90 (With Comorbidities)
Within 7 days post-vaccination at Day 1 and Day 90
Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1 and Day 90 (With Comorbidities)
Within 14 days post-vaccination at Day 1 and Day 90
Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 days Post Vaccination at Day 1 and Day 90 (With Comorbidities)
Within 7 days post-vaccination at Day 1 and Day 90
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mLEXPERIMENTALParticipants with the age group greater than (\>) 60 to 79 years will receive TDV, 0.5 mL subcutaneous (SC) injections, on Day 1 and Day 90.
Cohort 1: PlaceboPLACEBO_COMPARATORParticipants with the age group \>60 to 79 years will receive placebo (normal saline), 0.5 mL SC injections, on Day 1 and Day 90.
Cohort 2: TDV 0.5 mLEXPERIMENTALParticipants with the age group 45 to 60 years will receive TDV, 0.5 mL SC injection, on Day 1 and Day 90.
Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mL (Age group: >=12 to <21 months)EXPERIMENTALParticipants with the age group \>= 12 to \< 21 months receive TDV 0.5 mL subcutaneous (SC) injection, on Day 1 and Day 90.
Cohort 1: Placebo (Age group: >=12 to <21 months)EXPERIMENTALParticipants with the age group \>= 12 to \< 21 months receive placebo (normal saline), SC injection, on Day 1 and Day 90.
Cohort 2: TDV 0.5 mL(Age group: >=6 to <12 months)EXPERIMENTALParticipants with the age group \>=6 to \<12 months receive TDV, 0.5 mL SC injection, on Day 1 and Day 90.
Cohort 2: Placebo (Age group: >=6 to <12 months)EXPERIMENTALParticipants with the age group \>=6 to \<12 months receive placebo (normal saline), SC injection, on Day 1 and Day 90.
Cohort 1: TDV 0.5 mLEXPERIMENTALParticipants with the age group 18 to 60 years will receive TDV, 0.5 milliliter (mL) subcutaneous (SC) injections, on Day 1 and Day 90.
TDV: Flavivirus-naïveEXPERIMENTALTetravalent Dengue Vaccine (TDV) 0.5 mL, subcutaneous (SC) injection, once on Day 1 (first dose) and then on Day 90 (second dose). Participants who were flavivirus-naïve were included in this group.
TDV: DENV Immune: DENV-1 PositiveEXPERIMENTALTDV 0.5 mL, SC injection, once on Day 1 (first dose) and then on Day 90 (second dose). Participants with serology consistent with primary infection by wild type dengue virus serotype-1 (DENV-1) were included in this group.
TDV: DENV Immune: DENV-3 PositiveEXPERIMENTALTDV 0.5 mL, SC injection, once on Day 1 (first dose) and then on Day 90 (second dose). Participants with serology consistent with primary infection by DENV-3 were included in this group.
Group 1: TDV SC_2 Doses Day 0EXPERIMENTALTakeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using a needle/syringe.
Group 2: TDV IM_2 Doses Day 0EXPERIMENTALTDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using a needle/syringe.
Group 3: TDV IM_2 Doses Days 0 and 90EXPERIMENTALTDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using a needle/syringe.
Group 4: TDV SC_2 Doses Day 0EXPERIMENTALTDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using the PharmaJet Stratis™ device.
Group 5: TDV IM_2 Doses Day 0EXPERIMENTALTDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using the PharmaJet Stratis™ device.
Interventions
NameTypeDescription
TDVBIOLOGICALTDV SC injection.
PlaceboOTHERPlacebo SC injection.
Unlock Study Design Details
Eligibility Criteria
Age Range45 Years — 79 Years
SexALL
Healthy VolunteersYes
Study Sites7

Inclusion Criteria: 1. Participant is aged 45 to 79 years at the time of entry into the trial. 2. Participant is male or female. 3. Participant is in good health or has a medical diagnosis of one or more of diabetes mellitus, hypertension, or chronic kidney disease (that is, comorbidities) and are ...

Countries:ArgentinaBrazilSingaporeThailandColombiaJapanUnited States
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06579755primaryCompletionDate: changed
LOWMay 26, 2026NCT06665035primaryCompletionDate: changed
LOWMay 24, 2026NCT06579755studyFirstPostDate: changed
LOWMay 24, 2026NCT06665035studyFirstPostDate: changed