Dengue fever MedDRA version: 20.1 Level: LLT Classification code 10012312 Term: Dengue fever virus infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Qdenga®
Product Name: Dengue Tetravalent Vaccine (Live, Attenuated)
Product Code: TAK-003
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Dengue vir
Sponsors
Takeda Vaccines, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Is aged 4 to 16 years, inclusive (Latin America) or 4 to 8 years, inclusive (Asia). 2. Are in good health at the time of entry into the study as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator. Are the trial subjects under 18? yes Number of subjects for this age range: 200 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Febrile illness (body temperature =38°C) or moderate or severe acute illness or infection at the time of enrolment. 2. History or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose an additional risk to the participant due to participation in the study. 3. Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccines within 28 days after Day 1 (Month 0). 4. Previous participation in any clinical study of a dengue candidate vaccine, or previous receipt of any dengue vaccines (investigational or licensed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the cellular immune responses to 2 doses of TDV in healthy participants aged 4 to 16 years at 1 month post second vaccination.;Secondary Objective: 1. To assess cellular immune responses to 2 doses of TDV in healthy participants aged 4 to 16 years up to 3 years post second vaccination. 2. To assess cellular immune responses to 2 doses of TDV in healthy participants aged 4 to 16 years by region and dengue Baseline seropositivity status. 3. To characterize phenotype of cellular immune responses to TDV by cytokine staining (ICS) in a subset of study participants. 4. To assess the post-vaccination neutralizing antibody response against each dengue serotype. 5. To assess the post-vaccination neutralizing antibody response against multiple dengue serotypes. 6. To describe the safety of 2 doses of TDV in healthy participants aged 4 to 16 years.;Primary end point(s): Percentage of Participants With Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination;Timepoint(s) of evaluation of this end point: 1 month post second vaccination (Day 120) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Magnitude of Cellular Immune Response Assessed by Number of Spot Forming Cells (SFC)/Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by IFN-? ELISPOT at 1 Month Post Second Vaccination (Day 120) 2. Percentage of Participants With Cellular Immune Response to TDV at 1 Month Post First Vaccination (Day 30), Pre-second Vaccination, 6 Months Post Second Vaccination (Day 270) 3. Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-? ELISPOT at 1 Month Post First Vaccination (Day 30), Pre-second Vaccination, 6 Months Post Second Vaccination (Day 270) 4. Percentage of Participants With Cellular Immune Responses to TDV at 1 Month Post First Vaccination (Day 30), Pre-second Vaccination, 1 and 6 Months Post Second Vaccination Post Second Vaccination (Days 120 and Days 270) Assessed by Country 5. Percentage of Participants With Cellular Immune Responses to TDV:1 Month Post First Vaccination (Day 30), Pre-second Vaccination, 1 and 6 Months Post Second Vaccination Post Second Vaccination (Days 120 and Days 270), by Dengue Baseline Seropositivity Status 6. Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-? ELISPOT at 1 Month Post First (Day 30), Pre- Second Vaccination, 1 and 6 Months Post Second Vaccination (Days 120 and Days 270), by Country 7. Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-? ELISPOT 1 Month Post First (Day 30); Pre-second Vaccination; 1 and 6 Months Post Second Vaccination (Days 120 and Days 270), by Dengue Baseline Seropositivity Status 8. Percentage of Participants With Cellular Immune Response to TDV in Participants >10 Years of Age at Day 14 9. Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-? ELISPOT in Participants >10 Years of Age at Day 14 10. Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells o | — |
Countries
Panama, Philippines
Contacts
Public ContactStudy Director
Takeda Vaccines, Inc.
Outcome results
None listed