Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TDV, QDENGA, DENVax, Dengue Tetravalent Vaccine (TDV), Tetravalent Dengue Vaccine (TDV)
TAK-003 · 10 trials · 2 indications
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.
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.
Solicited systemic AEs include fever (body temperature greater than or equal to \[\>=\] 38 degree Celsius \[C\], asthenia, malaise, headache, and myalgia.
Solicited systemic AEs include fever (body temperature \>= 38 degree (C), asthenia, malaise, headache, and myalgia.
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.
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.
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.
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.
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).
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).
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.
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.
GMTs of neutralizing antibodies will be measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. GMTs of neutralizing antibodies (by MNT) against each of the 4 dengue serotypes at Day 120 in the TDV (new) and TDV (current) groups will be reported.
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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 were measured for each of the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.
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 were measured for each of the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.
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 were measured for each of the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.
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 were measured for each of the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.
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 were measured for each of the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT50.
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.
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.
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.
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.
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 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.
Solicited local reactions were reported using a participant diary. Pain was categorized as Mild (aware of pain but it does not interfere with daily activity and no pain medication is taken); Moderate (aware of pain; there is interference with daily activity or it requires use of pain medication); Severe (aware of pain and it prevents daily activity), redness was categorized as Mild (greater than \[\>\] 15 millimeter \[mm\]); Moderate as (15-30 mm); Severe (\>30 mm), swelling was categorized as Mild (\<15 mm); Moderate (15-30 mm); Severe (\>30 mm), and itching was categorized as Mild (slight itching at injection site); Moderate (moderate itching at injection extremity); Severe (itching over entire body).
Solicited systemic AEs were reported using a participant diary. Solicited systemic AEs included fever (\>= 37.8°C), headache, muscle pain, joint pain, eye pain, photophobia, fatigue, body rash, nausea, vomiting and other (any other symptom not listed in the diary) and were categorized as Mild: transient symptoms, discomfort noticed but easily tolerated, no interference to normal daily activities; Moderate: marked symptoms, moderate interference with daily activities; Severe: considerable interference with daily activities.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mL | EXPERIMENTAL | Participants 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: Placebo | PLACEBO_COMPARATOR | Participants 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 mL | EXPERIMENTAL | Participants with the age group 45 to 60 years will receive TDV, 0.5 mL SC injection, on Day 1 and Day 90. |
| Tetravalent Dengue Vaccine (TDV) (New) | EXPERIMENTAL | Participants will receive TDV (new formulation) dose 1, subcutaneous injection, once on Day 1 (first dose) and Day 90 (second dose). |
| Tetravalent Dengue Vaccine (TDV) (current) | EXPERIMENTAL | Participants will receive TDV (current approved formulation) 0.5 mL dose, subcutaneous injection, once on Day 1 (first dose) and Day 90 (second dose). |
| Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mL (Age group: >=12 to <21 months) | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants 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) | EXPERIMENTAL | Participants with the age group \>=6 to \<12 months receive placebo (normal saline), SC injection, on Day 1 and Day 90. |
| Tetravalent Dengue Vaccine (TDV) | EXPERIMENTAL | TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose). |
| Placebo | PLACEBO_COMPARATOR | TDV placebo matching injection, subcutaneously (SC) once on Day 1, and Day 90. |
| 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. |
| 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. |
| 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. |
| Cohort 1: TDV 0.5 mL | EXPERIMENTAL | Participants 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-naïve | EXPERIMENTAL | Tetravalent 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 Positive | EXPERIMENTAL | TDV 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 Positive | EXPERIMENTAL | TDV 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 0 | EXPERIMENTAL | Takeda'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 0 | EXPERIMENTAL | TDV, 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 90 | EXPERIMENTAL | TDV, 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 0 | EXPERIMENTAL | TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using the PharmaJet Stratis™ device. |
| Group 5: TDV IM_2 Doses Day 0 | EXPERIMENTAL | TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using the PharmaJet Stratis™ device. |
| Group 1: Low Dose; SC | EXPERIMENTAL | TDV-1: 8 x 10\^3 Plaque Forming Units (PFU), TDV-2: 5 x 10\^3 PFU, TDV-3: 1 x 10\^4 PFU, TDV-4: 2 x 10\^5 PFU or placebo administered subcutaneously on Days 0 and 90. Dose volume is 0.5 mL. |
| Group 2: Low Dose; ID | EXPERIMENTAL | TDV-1: 8 x 10\^3 PFU, TDV-2: 5 x 10\^3 PFU, TDV-3: 1 x 10\^4 PFU, TDV-4: 2 x 10\^5 PFU or placebo administered intradermally on Days 0 and 90. Dose volume is 0.1 mL. |
| Group 3: High Dose; SC | EXPERIMENTAL | TDV-1: 2 x 10\^4 PFU, TDV-2: 5 x 10\^4 PFU, TDV-3: 1 x 10\^5 PFU, TDV-4: 3 x 10\^5 PFU or placebo administered subcutaneously on Days 0 and 90. Dose volume is 0.5 mL. |
| Group 4: High Dose; ID | EXPERIMENTAL | TDV-1: 2 x 10\^4 PFU, TDV-2: 5 x 10\^4 PFU, TDV-3: 1 x 10\^5 PFU, TDV-4: 3 x 10\^5 PFU or placebo administered intradermally on Days 0 and 90. Dose volume is 0.1 mL. |
| Placebo (SC) | PLACEBO_COMPARATOR | Phosphate buffered saline administered subcutaneously in a volume of 0.5 mL. |
| Placebo (ID) | PLACEBO_COMPARATOR | Phosphate buffered saline administered intradermally in a dose volume of 0.1 mL. |
| Name | Type | Description |
|---|---|---|
| TDV | BIOLOGICAL | TDV SC injection. |
| Placebo | OTHER | Placebo SC injection. |
| Tetravalent Dengue Vaccine (TDV) | BIOLOGICAL | TDV subcutaneous injection |
| TAK-003 | BIOLOGICAL | TDV subcutaneous injection |
| TDV - Low Dose | BIOLOGICAL | TDV is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8 x 10\^3 PFU, TDV-2: 5 x 10\^3 PFU, TDV-3: 1 x 10\^4 PFU, and TDV-4: 2 x 10\^5 PFU, total virus per dose 2.2 x 10\^5 PFU |
| TDV - High Dose | BIOLOGICAL | TDV is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2 x 10\^4 PFU, TDV-2: 5 x 10\^4 PFU, TDV-3: 1 x 10\^5 PFU, and TDV-4: 3 x 10\^5 PFU, total virus per dose : 4.7 x 10\^5 PFU. TDV administered intradermally. |
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 ...
TAK-003 is an investigational vaccine being developed for the prevention of Dengue Fever. It is a tetravalent dengue vaccine (TDV) designed to protect against the disease. As of the available data, it has completed a Phase 3 clinical trial and remains in clinical development, not yet approved.
TAK-003 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy for Dengue Fever prevention.
TAK-003 is in Phase 3 clinical development. A Phase 3 trial has been completed, but the vaccine is still investigational and has not received regulatory approval. It is being studied for the prevention of Dengue Fever.
TAK-003 has one completed Phase 3 trial, NCT03423173, titled 'Lot-to-lot Consistency of 3 Lots of Tetravalent Dengue Vaccine (TDV) in Non-endemic Country(Ies) for Dengue.' This randomized, double-blind, placebo-controlled study enrolled 923 healthy adults aged 18 years and older in the United States.
TAK-003 is not FDA approved. It is an investigational vaccine currently in clinical development for Dengue Fever. A Phase 3 trial has been completed, but regulatory approval has not been granted based on the available information.