Safety and Immunogenicity of Takeda's TDV in Healthy Children

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02948829
• Date of registration: 26/10/2016
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: Safety and Immunogenicity of Takeda's TDV in Healthy Children
• Scientific 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
• Date of first enrolment: April 3, 2017
• Target sample size: 243
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02948829
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Panama, Philippines

Contacts

• Name: Medical Director Clinical Science
• Affiliation: Takeda

Key inclusion & exclusion 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.

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).



Age minimum: 4 Years
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy Volunteers

Intervention(s)

Biological: Tetravalent Dengue Vaccine Candidate

Primary Outcome(s)

Percentage of Participants with Cellular Immune Response to 2 Doses of Tetravalent Dengue Vaccine (TDV) at 1 Month Post Second Vaccination [Time Frame: Day 120 (Month 4)]

Secondary Outcome(s)

Phenotype Characterization of Cellular Immune Responses to TDV by Region and Dengue Baseline Seropositivity Status [Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years)]

Magnitude of IFN- ? ELISPOT Responses to TDV by Region and Dengue Baseline Seropositivity Status [Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years)]

Percentage of Participants With Serious Adverse Events (SAEs) [Time Frame: Up to 3 years 3 months]

Percentage of Participants Experiencing Non-serious Unsolicited Adverse Events (AE) [Time Frame: Up to 28 days (day of vaccination +27 days) after the first (Day 1) and second vaccination (Day 90)]

Percentage of Participants With IFN- ? ELISPOT Responses to TDV by Region and Dengue Baseline Seropositivity Status [Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years)]

Phenotype Characterization of Cellular Response to TDV Assessed by Intracellular Cytokine Staining (ICS) [Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years)]

Percentage of Participants With Medically Attended AEs (MAAEs) [Time Frame: First vaccination (Day 1) up to 6 months after second vaccination (Day 90)]

Percentage of Participants with Seropositivity for Each of the 4 Dengue Serotypes [Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years)]

Magnitude of IFN-? ELISPOT Responses to 2 Doses of TDV at 1 Month Post Second Vaccination [Time Frame: Day 120 (Month 4)]

Geometric Mean Titer (GMT) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes [Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years)]

Magnitude of IFN-? ELISPOT Response to TDV [Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years)]

Magnitude of IFN- ? ELISPOT Responses to TDV in Participants >10 Years of Age [Time Frame: Day 14]

Percentage of Participants With IFN-? ELISPOT Response to TDV [Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years)]

Percentage of Participants With IFN- ? ELISPOT Responses to TDV in Participants >10 Years of Age [Time Frame: Day 14]

Percentage of Participants With Virologically Confirmed Febrile Illness with Potential Dengue Etiology [Time Frame: First vaccination (Day 1) up to 3 years after the second vaccination (Day 90)]

Percentage of Participants with Seropositivity for Multiple (2, 3 or 4) Dengue Serotypes [Time Frame: 1 month post first vaccination (Day 30), pre-second vaccination (Day 90]), 6 months post second vaccination (Day 270), and then annually (up to 3 years)]

Secondary ID(s)

DEN-313

U1111-1184-1893

Source(s) of Monetary Support

Please refer to primary and secondary sponsors