Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children

• Register: ClinicalTrials.gov
• Last refreshed on: 12 February 2024
• Main ID: NCT02747927
• Date of registration: 14/04/2016
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children TIDES
• Scientific title: Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in Healthy Children Aged 4 - 16 Years Old
• Date of first enrolment: September 7, 2016
• Target sample size: 20099
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02747927
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Peru, Philippines, Sri Lanka, Thailand, Vietnam

Contacts

• Name: Medical Director
• Affiliation: Takeda

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Is aged 4 to 16 years, inclusive, at the time of randomization.

2. Is in good health at the time of entry into the trial as determined by medical
history, physical examination (including vital signs) and clinical judgment of the
Investigator.

3. The participant and/or the participant's parent/guardian signs and dates an
assent/written informed consent form where applicable, and any required privacy
authorization prior to the initiation of any trial procedures, after the nature of the
trial has been explained according to local regulatory requirements.

4. Can comply with trial procedures and are available for the duration of follow-up.

Inclusion criteria for Booster Phase:

1. Is included in the per-protocol set (PPS) of the trial.

2. Was aged 4 to 11 years at the time of randomization in the study (Day 1 [Month 0]).

Exclusion Criteria:

1. Has febrile illness (temperature =38°C) or moderate or severe acute illness or
infection at the time of randomization.

2. Has history of or any illness that, in the opinion of the Investigator, might
interfere with the results of the trial or pose an additional risk to the participant
due to participation in the trial.

3. Has received any other vaccine within 14 days (for inactivated vaccines) or 28 days
(for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccine within
28 days after Day 1 (Month 0).

4. Has participated in any clinical trial with another investigational product 30 days
prior to Day 1 (Month 0) or intent to participate in another clinical trial at any
time during the conduct of this trial.

5. Has previously participated in any clinical trial of a dengue candidate vaccine, or
previous receipt of a dengue vaccine.

6. Is first degree relative of individuals involved in trial conduct.

7. Females of childbearing potential who are sexually active, and who have not used any
of the acceptable contraceptive methods for at least 2 months prior to Day 1 (Month
0).

8. Females of childbearing potential who are sexually active, and who refuse to use an
acceptable contraceptive method up to 6 weeks post-second vaccination.

9. Deprived of freedom by administrative or court order, or in an emergency setting, or
hospitalized involuntarily.

10. Current alcohol abuse or drug addiction that may interfere with the participant's
ability to comply with trial procedures.

11. Identified as an employee of the Investigator or trial center, with direct involvement
in the proposed trial or other trials under the direction of that Investigator or
trial center.

Exclusion criteria for Booster Phase:

1. Receipt of any other vaccine within 14 days (for inactivated vaccines) or 28 days (for
live vaccines) prior to Day 1b (Month 0b), or planning to receive any vaccine within
28 days after Day 1b (Month 0b).

2. Participation in any clinical trial with another investigational product at any time
during participation in this trial or intent to participate in another clinical trial
at any time during the conduct of the booster phase of this trial.



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 (TDV)

Drug: Placebo

Primary Outcome(s)

Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine Candidate (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype [Time Frame: 30 days post-second vaccination (Day 120) until the end of Part 1 (120 cases of dengue fever are confirmed and minimum duration of participant follow-up of 12 months post-second vaccination)]

Secondary Outcome(s)

Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes in the Immunogenicity Subset [Time Frame: Prevaccination on Day 1, post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)]

Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Subset [Time Frame: Days 1 through 14 after each vaccination]

VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype [Time Frame: From 30 days post-second vaccination (Day 120) until the end of Part 2 (up to 21 months)]

Severity of Solicited Systemic Adverse Events (AEs) in the Safety Subset [Time Frame: Days 1 through 14 after each vaccination]

Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset [Time Frame: Prevaccination on Day 1, post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)]

VE of Two Doses of TDV in Preventing Virologically-Confirmed Severe Dengue Fever Induced by Any Dengue Serotype [Time Frame: From 30 days post-second vaccination (Day 120) until the end of Part 2 (up to 21 months)]

Percentage of Participants With a Seropositive Response for Multiple Dengue Serotypes in the Immunogenicity Subset [Time Frame: Prevaccination on Day 1, post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)]

Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3 [Time Frame: First and Second half (18 months each) of Part 3 (up to 3 years, beginning at Month 22)]

Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2 [Time Frame: From Day 1 until the end of Parts 1 and 2 (approximately 21 months)]

VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seronegative at Baseline [Time Frame: From 30 days post-second vaccination (Day 120) until the end of Part 2 (up to 21 months)]

VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seropositive at Baseline [Time Frame: From 30 days post-second vaccination (Day 120) until the end of Part 2 (up to 21 months)]

Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Subset [Time Frame: Days 1 through 28 after each vaccination]

Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Subset [Time Frame: Days 1 through 7 after each vaccination]

VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype [Time Frame: From 30 days post-second vaccination (Day 120) until the end of Part 2 (up to 21 months)]

Secondary ID(s)

PHRR150522-001010

2018-003979-34

DEN-301

U1111-1166-8401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/08/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02747927