Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TDV · 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.
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.
Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for infant/toddler/child (\<6 years of age).
Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for child/adolescent/adult (≥6 years of age).
Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for infant/toddler/child (\<6 years of age).
Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for child/adolescent/adult (≥6 years of age).
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. Solicited systemic AEs assessments for children \<6 years old comprised: irritability/fussiness, drowsiness, loss of appetite (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated).
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. Solicited systemic AEs assessments for children ≥ 6 years old/adolescents/adults comprised: headache, asthenia, malaise, myalgia (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated).
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. Solicited systemic AEs assessments for children \<6 years old comprised: drowsiness, irritability/fussiness, loss of appetite (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe). Data for drowsiness, irritability/fussiness and loss of appetite has been reported in this outcome measure.
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. Solicited systemic AEs assessments for children \<6 years old also comprised of fever in °C (collected by temperature ranges as indicated). Data for fever has been reported in this outcome measure.
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. Solicited systemic AEs assessments for children ≥ 6 years old/adolescents/adults comprised: headache, asthenia, malaise, myalgia (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated).
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.
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.
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.
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.
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.
GMTs of neutralizing antibodies were measured by microneutralization test 50% (MNT50) for each of the 4 dengue serotypes for all participants. The 4 dengue virus serotypes (DENV) are DENV-1, DENV-2, DENV-3 and DENV-4.
Seroprotection is defined as serum anti-HAV antibody levels ≥12.5 mIU/mL, measured by enzyme-linked immunosorbent assay (ELISA). Immunological naivety to HAV/DENV is defined as anti-HAV antibody levels \<12.5 mIU/mL and reciprocal neutralizing titers for all 4 dengue serotypes \<10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
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.
Percentage of participants with cellular immune response were reported. Cellular immune response was defined as an interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISPOT) response that was \>3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included non-structural proteins (NS) NS3 and NS5 for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4 and NS1 for DENV-2. Percentage of participants with cellular immune response were reported. Percentages are rounded off to the nearest decimal point.
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site reactions were evaluated by the blinded clinical staff and include: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Severity grades for erythema and edema are derived based on the Division of Microbiology and Infectious Diseases (DMID) toxicity grading longest diameters using the scale 0=none, 1=\<15 millimeters (mm), 2=15 to 30 mm and 3=\>30 mm (severe). Pain and itching were graded using the scale: 0=none to 4=requires ER visit or hospitalization. Local injection site reactions are presented as the percentage 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.
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE, overall and by severity, using the participant's worst reported severity grade.
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Systemic AEs solicited from the participant using a memory aid included: body temperature, headache, myalgia (muscle pain), arthralgia (joint pain), photophobia (sensitivity to light), fatigue (tiredness), body rash, nausea and vomiting. Systemic AEs were graded using the scale: Grade 0= none to Grade 4=Life threatening. Systemic reactions are presented as percentage 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.
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site AEs solicited from the participant using a memory aid included: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade.
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE causally related to the study treatment as assessed by the investigator, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.
The percentage of participants with any clinically relevant abnormal safety laboratory values (chemistry, hematology and urinalysis) collected from vaccine dose 1 (Day 0) through 28 days after dose 2 (Day 90) that were reported as AEs. Abnormal laboratory values were reported as AEs based on the following criteria: Grade 3 (Severe) or Grade 4 (Life threatening) laboratory abnormalities based on DMID toxicity tables or laboratory abnormalities which resulted in a medical intervention.
Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
A serious adverse event (SAE) is any AE in the view of the investigator that results in any of the following outcomes: death, life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that may require medical or surgical intervention to prevent one of the other serious outcomes.
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. |
| 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. |
| Cohort 1: ≥18 to ≤60 Years Age Group: TDV | EXPERIMENTAL | Participants received TDV subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
| Cohort 1: ≥18 to ≤60 Years Age Group: Placebo | PLACEBO_COMPARATOR | Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
| Cohort 2: ≥4 to <18 Years Age Group: TDV | EXPERIMENTAL | Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
| Cohort 2: ≥4 to <18 Years Age Group: Placebo | PLACEBO_COMPARATOR | Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
| HAV Vaccine 1.0 ml + Placebo/ Placebo | OTHER | HAV vaccine 1.0 ml, injection, IM, and placebo-matching injection, SC, once on Day 1 (first dose) followed by placebo-matching injection, SC on Day 90 (second dose). |
| TDV 0.5 ml + Placebo/ TDV 0.5 ml | EXPERIMENTAL | TDV 0.5 ml, injection, SC, and placebo-matching injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose). |
| TDV 0.5 ml + HAV Vaccine 1.0 ml/ TDV 0.5 ml | EXPERIMENTAL | TDV 0.5 ml, injection, SC, and HAV vaccine 1.0 ml, injection, IM, once on Day 1 (first dose) followed by TDV 0.5 ml, injection, SC on Day 90 (second dose). |
| 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. |
| Tetravalent Dengue Vaccine (TDV) 0.5 mL | EXPERIMENTAL | TDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3). |
| Group 1: TDV using PharmaJet® Injector | EXPERIMENTAL | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
| Group 2: TDV using PharmaJet® Injector | EXPERIMENTAL | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
| Group 3: TDV using Needle and Syringe | EXPERIMENTAL | TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. |
| Group 4: TDV using PharmaJet® Injector | EXPERIMENTAL | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
| 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. |
| HAV Vaccine | BIOLOGICAL | HAV Vaccine IM injection. |
| TDV Placebo | BIOLOGICAL | Placebo-matching (normal saline (0.9% NaCl) SC injection. |
| HAV Vaccine Placebo | BIOLOGICAL | Placebo-matching (normal saline (0.9% NaCl) IM 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 ...
TDV is an investigational tetravalent dengue vaccine being developed for the prevention of dengue fever. It is being studied in healthy children, teenagers, and adults, including healthy volunteers, to assess its safety and immunogenicity. TDV is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
TDV is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company listed on the stock exchange under the ticker TAK. Takeda is conducting clinical trials to evaluate the safety and immunogenicity of TDV in various populations, including healthy children and adults, across multiple countries.
TDV is currently in Phase 3 clinical development. It has completed Phase 1, Phase 2, and Phase 3 trials, with a total of six trials conducted, including four completed and two active. TDV is an investigational vaccine and has not yet received regulatory approval for dengue fever prevention.
TDV has been studied in several clinical trials, including NCT01765426, a Phase 1b study in healthy volunteers in the United States; NCT02948829, a Phase 2 study in healthy children in Panama and the Philippines; NCT03525119, a Phase 3 study co-administered with a hepatitis A vaccine in the United Kingdom; and NCT06060067, a Phase 3 study in healthy children, teenagers, and adults in India.
TDV is a tetravalent dengue vaccine designed to protect against all four serotypes of the dengue virus. It works by stimulating the immune system to produce antibodies against the virus, potentially providing immunity against dengue fever. The vaccine is being evaluated in clinical trials for its safety and immunogenicity in healthy populations.
TDV is a distinct tetravalent dengue vaccine developed by Takeda. It is not the same as other dengue vaccines, as it is specifically formulated to target all four dengue virus serotypes. TDV is currently in Phase 3 clinical trials and has not been approved for use, distinguishing it from any licensed dengue vaccines.