Phase 2
N=200
Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02948829 ↗Enrolled (actual)
200
Serious AEs
5.5%
Results posted
Apr 2021
Primary outcome: Primary: Percentage of Participants With Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination — 97.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TDV (Biological)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination |
97.1 | — |
| SECONDARY Magnitude of Cellular Immune Response Assessed by Number of Spot Forming Cells (SFC)/Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by IFN-γ ELISPOT at 1 Month Post Second Vaccination |
846.5 | — |
| SECONDARY Percentage of Participants With Cellular Immune Response to TDV at 1 Month Post First Vaccination, Pre-second Vaccination, 6 Months Post Second Vaccination, and Annually at Years 1, 2, and 3 |
95.3; 95.1; 95.4; 90.8; 84.0; 77.8 | — |
| SECONDARY Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First Vaccination, Pre-second Vaccination, 6 Months Post Second Vaccination, and Annually at Years 1, 2, and 3 |
1019.0; 536.5; 486.0; 193.0; 104.0; 136.0 | — |
| SECONDARY Percentage of Participants With Cellular Immune Responses to TDV at 1 Month Post First Vaccination, Pre-second Vaccination, 1 and 6 Months Post Second Vaccination, and Annually at Years 1, 2, and 3 Assessed by Country |
96.1; 94.7; 96.5; 93.9; 97.3; 96.9 | — |
| SECONDARY Percentage of Participants With Cellular Immune Responses to TDV:1 Month Post First Vaccination, Pre-second Vaccination, 1 and 6 Months Post Second Vaccination, and Annually at Years 1, 2, and 3, by Dengue Baseline Seropositivity Status |
91.8; 100.0; 93.3; 97.5; 96.0; 98.6 | — |
| SECONDARY Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT at 1 Month Post First, Pre- Second Vaccination, 1 and 6 Months Post Second Vaccination, and Annually at Years 1, 2, and 3 by Country |
1019.0; 1065.0; 531.5; 577.5; 780.0; 1003.0 | — |
| SECONDARY Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT 1Month Post First Vaccination,Pre-second Vaccination;1,6Months Post Second Vaccination, Annually at Years1,2,3 by Dengue Baseline Seropositivity Status |
1415.0; 840.5; 743.0; 473.0; 1086.0; 700.0 | — |
| SECONDARY Percentage of Participants With Cellular Immune Response to TDV in Participants >10 Years of Age |
70.0 | — |
| SECONDARY Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT in Participants >10 Years of Age |
227.0 | — |
| SECONDARY Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response to DENV-2 NS Peptides at 1Month Post First Vaccination,Pre-second Vaccination;1,6Months Post Second Vaccination, Annually at Years1,2,3 |
0.008260; 0.001350; 0.005110; 0.020000; 0.005380; 0.015580 | — |
| SECONDARY Phenotype Characterization of Cellular Immune Response Assessed by Percentage of Total T Cells of Cellular Response DENV-2 NS Peptides,1Month Post First Vaccination,Pre Second Vaccination;1,6Months Post Second Vaccination,Annually at Years1,2,3 by Country |
0.005670; 0.010590; 0.001655; 0.001350; 0.002700; 0.006810 | — |
| SECONDARY Phenotype Characterization of Cellular Immune Response by Percentage of Total T Cells DENV-2 NS Peptides at 1Month Post First Vaccination,Pre Second Vaccination;1,6Months Post Second Vaccination,Annually at Years1,2,3 by Dengue Baseline Seropositivity |
0.013000; 0.007655; 0.002170; 0.000245; 0.005140; 0.004985 | — |
| SECONDARY Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination, Pre Second Vaccination, and 1, 6 Months Post Second Vaccination and Then Annually Up to 3 Years |
402.3; 5482.2; 436.1; 253.9; 271.7; 2736.3 | — |
| SECONDARY Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 1 Month Post First Vaccination, Pre-second Vaccination, and 1, 6 Months Post Second Vaccination and Then Annually up to 3 Years |
96.8; 99.5; 99.5; 93.0; 90.8; 99.5 | — |
| SECONDARY Percentage of Participants Seropositive for Multiple Dengue Serotypes at 1 Month Post First Vaccination, Pre Second Vaccination, 1, 6 Months Post Second Vaccination and Annually up to 3 Years |
90.8; 98.4; 83.6; 95.4; 99.5; 100.0 | — |
| SECONDARY Percentage of Participants Experiencing Unsolicited Adverse Events (AE) |
26.5; 25.3 | — |
| SECONDARY Percentage of Participants With Medically Attended AEs (MAAEs) |
50.5 | — |
| SECONDARY Percentage of Participants With Serious Adverse Events (SAEs) |
5.5 | — |
| SECONDARY Percentage of Participants With Virologically Confirmed Dengue |
6.0 | — |
Summary
The purpose of this study is to assess the cellular immune responses following 2 doses given 3 months apart of tetravalent dengue vaccine candidate (TDV) in 4 to 16 years' healthy participants.
Eligibility Criteria
Main Inclusion Criteria:
- Is aged 4 to 16 years, inclusive (Latin America) or 4 to 8 years, inclusive (Asia).
- 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.
Main Exclusion Criteria:
- Febrile illness (body temperature ≥38°C) or moderate or severe acute illness or infection at the time of enrolment.
- 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.
- 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).
- Previous participation in any clinical study of a dengue candidate vaccine, or previous receipt of any dengue vaccines (investigational or licensed).
Data sourced from ClinicalTrials.gov (NCT02948829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.