Healthy VolunteersPhase 2NCT02948829
Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
A Phase 2 study testing TDV in people with Healthy Volunteers, run by Takeda at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TDV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Apr 2017to 14 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Philippines1 site
Research Institute for Tropical Medicine
City of Muntinlupa, 1781
About this study
Official title: An Open Label, Phase 2 Study to Investigate Cell-mediated Immunity and Safety of a Tetravalent Dengue Vaccine Candidate (TDV) Administered Subcutaneously in Healthy Children Aged 4 to 16 Years
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.
Read the detailed description
The vaccine tested in this study was TDV. This study assessed cellular immune responses and safety up to 3 years post second TDV administration to healthy children aged 4 to 16 years and in dengue endemic regions.
The study enrolled 200 participants. Participants received:
- TDV 0.5 mL subcutaneous (SC) injection into the upper arm at Day 1 (Month 0) and at Day 90 (Month 3).
This multi-center trial was conducted in Panama and Philippines. 198 participants received the 2-dose schedule of TDV, and 2 participants received only the first dose of TDV (Day 1). Participants made multiple visits to the clinic and were contacted at least every week for the entire study duration post first injection.
- Conditions
- Healthy Volunteers
- Being tested
- TDV
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDVBiological
TDV SC injection.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: TDV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination
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.
Measured: 1 month post second vaccination (Day 120)
Secondary outcomes (19)
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
The magnitude of cellular immune response was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Data (SFC/million PBMC) for participants with a cellular immune response to any peptide pool is reported. The peptide pool included NS3 and NS5 for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4 and NS1 for DENV-2.
Measured: 1 month post second vaccination (Day 120)
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
Percentage of participants with cellular immune response were reported. Cellular immune response was defined as an IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1 [M0]) and >=5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included NS3 and NS5 for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4 and NS1 for DENV-2. Percentages are rounded off to the nearest decimal point.
Measured: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 6 months post second vaccination (Day 270); Years 1, 2 and 3
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
The magnitude of cellular immune response was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Data (SFC/million PBMC) for participants with a cellular immune response to any peptide pool is reported. The peptide pool included NS3 and NS5 for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4 and NS1 for DENV-2.
Measured: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 6 months post second vaccination (Days 120 and 270); Years 1, 2 and 3
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
Percentage of participants with cellular immune response by country were reported. Cellular immune response was defined as an IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1 [M0]) and >=5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included NS3 and NS5 for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4 and NS1 for DENV-2. Data is reported as per enrollment by country (Panama and Philippines). Percentages are rounded off to the nearest decimal point.
Measured: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90) 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, 3
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
Percentage of participants with cellular immune response by dengue Baseline seropositivity status were reported. Cellular immune response was defined as an IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1 [M0]) and >=5 spots per well. Seropositive at Baseline was defined as a reciprocal neutralizing titer >=10 for one or more dengue serotypes. Seronegative at Baseline was defined as having a reciprocal neutralizing titer <10 for all dengue serotypes. The 4 dengue virus serotypes were dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4. Cellular immune response to any peptide pool was reported. The peptide pool included NS3 and NS5 for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4 and NS1 for DENV-2. Data is reported per Baseline seropositivity status of participants (Seropositive and Seronegative). Percentages are rounded off to the nearest decimal point.
Measured: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3
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
The magnitude of cellular immune response by country was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Data (SFC/million PBMC) for participants with a cellular immune response to any peptide pool is reported. The peptide pool included NS3 and NS5 for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4 and NS1 for DENV-2. Data is reported as per enrollment by country (Panama and Philippines).
Measured: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3
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
The magnitude of cellular immune response by dengue Baseline seropositivity status was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1) and ≥ 5 spots per well. Seropositive at Baseline was defined as a reciprocal neutralizing titer >=10 for one or more dengue serotypes. Seronegative at Baseline was defined as having a reciprocal neutralizing titer <10 for all dengue serotypes. The 4 dengue virus serotypes were dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4. Cellular immune response to any peptide pool was reported. The peptide pool included NS3 and NS5 for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4 and NS1 for DENV-2. Data is reported per Baseline seropositivity status of participants (Seropositive and Seronegative).
Measured: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3
Percentage of Participants With Cellular Immune Response to TDV in Participants >10 Years of Age
Percentage of participants with cellular immune response in participants >10 years of age were reported. Cellular immune response was defined as an IFN-γ ELISPOT response that was >3 times higher compared to Baseline (Day 1 [M0]) and >=5 spots per well. Cellular immune response to any peptide pool was reported. The peptide pool included NS3 and NS5 for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4 and NS1 for DENV-2.
Measured: Day 14
Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT in Participants >10 Years of Age
The magnitude of cellular immune response was assessed by the number of SFC/million PBMCs for participants with a cellular immune response. Cellular immune response was defined as IFN-γ 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 NS3 and NS5 for each of the dengue serotype: DENV-1, DENV-2, DENV-3 and DENV-4 and NS1 for DENV-2. SFC/million PBMC for any peptide pool is reported in participants >10 years of age.
Measured: Day 14
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
The phenotype characterization of cellular immune response was assessed by intracellular cytokine staining (ICS) by the frequency of total cluster of differentiation 4 (CD4)+ and CD8+ T cells and was performed in a subset of participants with IFN- γ ELISPOT responses >500 SFC/million cells and availability of sufficient cells. The peptide pools included NS1, NS3 and NS5 for DENV-2 serotype. Data are presented for the different expression profiles of interferon-gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor-alpha (TNF-α) cytokines for each peptide pool. Data is reported based on the type of T cells present in participants at the time of analysis (CD4+ T cells and CD8+ T cells).
Measured: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3
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
The phenotype characterization of cellular immune response by country was assessed by ICS by the frequency of total CD4+ and CD8+ T cells and was performed in a subset of participants with IFN- γ ELISPOT responses >500 SFC/million cells and availability of sufficient cells. The peptide pools included NS1, NS3 and NS5 for DENV-2 serotype. Data are presented for the different expression profiles of IFN-γ, IL-2 and TNF-α cytokines for each peptide pool. Data is reported per country (Panama and Philippines) based on the type of T cells present in participants at the time of analysis (CD4+ T cells and CD8+ T cells).
Measured: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3
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
The phenotype characterization of cellular immune response by dengue Baseline seropositivity status was assessed by the frequency of total CD4+ and CD8+ T cells and was performed in a subset of participants with IFN- γ ELISPOT responses >500 SFC/million cells and availability of sufficient cells. Seropositive was defined as a reciprocal neutralizing titer (MNT50) >=10 for one or more dengue serotypes. Seronegative was defined as titer value of <10 for all 4 serotypes. The peptide pools included NS1, NS3 and NS5 for DENV-2 serotype. Data are presented for the different expression profiles of IFN-γ, IL-2 and TNF-α cytokines for each peptide pool. Data is reported per Baseline seropositivity status (Seropositive and Seronegative) based on the type of T cells present in participants at the time of analysis (CD4+ T cells and CD8+ T cells).
Measured: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3
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
GMT of neutralizing antibodies was measured by microneutralization test (MTN). The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Measured: 1 month post first vaccination (Day 30); pre second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); annually up to 3 years (Years 1, 2 and 3)
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
Seropositive was defined as a reciprocal neutralizing titer ≥10. The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Measured: 1 month post first vaccination (Day 30); pre second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); annually up to 3 years (Years 1, 2 and 3)
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
Seropositive was defined as a reciprocal neutralizing titer ≥10. The dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositive for multiple dengue serotypes were summarized in the following categories: tetravalent and at least trivalent.
Measured: 1 month post first vaccination (Day 30); pre second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); annually up to 3 years (Years 1, 2 and 3)
Percentage of Participants Experiencing Unsolicited Adverse Events (AE)
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration.
Measured: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 [Month 0] and Day 90 [Month 3]
Percentage of Participants With Medically Attended AEs (MAAEs)
MAAEs were defined as AEs leading to a medical visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria.
Measured: From first vaccination (Day 1) up to 6 months post second vaccination (Day 270)
Percentage of Participants With Serious Adverse Events (SAEs)
A SAE was defined as 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.
Measured: From first vaccination (Day 1) up to end of study (Approximately 3 years)
Percentage of Participants With Virologically Confirmed Dengue
Participants with febrile illness defined as fever ≥38°C on any 2 of 3 consecutive days were evaluated for dengue. Virologically confirmed dengue was defined as febrile illness with a positive serotype-specific RT-PCR (i.e. positive dengue detection RT-PCR).
Measured: From first vaccination (Day 1) up to 6 months post second vaccination (Day 270)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start3 Apr 2017
- Primary completion16 Oct 2017
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948829
- Sponsor's protocol ID
- DEN-313
- Other IDs
- U1111-1184-1893
- Status last verified
- Feb 2024
- First submitted
- 26 Oct 2016
- Last updated
- 15 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Publications
Rauscher M, Youard Z, Faccin A, Patel SS, Pang H, Zent O. Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. Expert Rev Vaccines. 2025 Dec;24(1):221-229. doi: 10.1080/14760584.2025.2480297. Epub 2025 Mar 27.
PubMed 40099800
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase 2 Study to Investigate Cell-mediated Immunity and Safety of a Tetravalent Dengue Vaccine Candidate (TDV) Administered Subcutaneously in Healthy Children Aged 4 to 16 Years
- ClinicalTrials.gov ID
- NCT02948829
- Acronym / sponsor ID
- DEN-313
- Conditions
- Healthy Volunteers
- Keywords
- Drug therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 16 Oct 2017 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Posted 26 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The vaccine tested in this study was TDV. This study assessed cellular immune responses and safety up to 3 years post second TDV administration to healthy children aged 4 to 16 years and in dengue endemic regions.
The study enrolled 200 participants. Participants received:
- TDV 0.5 mL subcutaneous (SC) injection into the upper arm at Day 1 (Month 0) and at Day 90 (Month 3).
This multi-center trial was conducted in Panama and Philippines. 198 participants received the 2-dose schedule of TDV, and 2 participants received only the first dose of TDV (Day 1). Participants made multiple visits to the clinic and were contacted at least every week for the entire study duration post first injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tetravalent Dengue Vaccine (TDV) 0.5 mL | Experimental | Biological: TDVTDV 0.5 mL, subcutaneous (SC) injection, on Day 1 (Month 0) and Day 90 (Month 3). |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDVTDV SC injection. | Biological | Tetravalent Dengue Vaccine (TDV) 0.5 mL |
Primary outcome
Percentage of Participants With Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination
Time frame: 1 month post second vaccination (Day 120)
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.
19 secondary outcomes
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
Time frame: 1 month post second vaccination (Day 120)
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
Time frame: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 6 months post second vaccination (Day 270); Years 1, 2 and 3
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
Time frame: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 6 months post second vaccination (Days 120 and 270); Years 1, 2 and 3
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
Time frame: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90) 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, 3
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
Time frame: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3
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
Time frame: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3
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
Time frame: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3
Percentage of Participants With Cellular Immune Response to TDV in Participants >10 Years of Age
Time frame: Day 14
Magnitude of Cellular Immune Response Assessed by Number of SFC/Million PBMCs Measured by IFN-γ ELISPOT in Participants >10 Years of Age
Time frame: Day 14
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
Time frame: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3
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
Time frame: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3
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
Time frame: 1 month post first vaccination (Day 30); pre-second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); Years 1, 2, and 3
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
Time frame: 1 month post first vaccination (Day 30); pre second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); annually up to 3 years (Years 1, 2 and 3)
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
Time frame: 1 month post first vaccination (Day 30); pre second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); annually up to 3 years (Years 1, 2 and 3)
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
Time frame: 1 month post first vaccination (Day 30); pre second vaccination (Day 90); 1 and 6 months post second vaccination (Days 120 and 270); annually up to 3 years (Years 1, 2 and 3)
Percentage of Participants Experiencing Unsolicited Adverse Events (AE)
Time frame: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Day 1 [Month 0] and Day 90 [Month 3]
Percentage of Participants With Medically Attended AEs (MAAEs)
Time frame: From first vaccination (Day 1) up to 6 months post second vaccination (Day 270)
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: From first vaccination (Day 1) up to end of study (Approximately 3 years)
Percentage of Participants With Virologically Confirmed Dengue
Time frame: From first vaccination (Day 1) up to 6 months post second vaccination (Day 270)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40099800Rauscher M, Youard Z, Faccin A, Patel SS, Pang H, Zent O. Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. Expert Rev Vaccines. 2025 Dec;24(1):221-229. doi: 10.1080/14760584.2025.2480297. Epub 2025 Mar 27.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Clinical Science study director
Takeda
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TDV in people with Healthy Volunteers, run by Takeda at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Panama, Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination (time frame: 1 month post second vaccination (Day 120)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02948829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.