A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-29

Study Completion Date

2025-05-05

Brief Summary

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The main aims of the study are to learn about side effects and a participant's immune response to Takeda's Dengue Vaccine when given twice within 3 months.

Participants will receive 2 doses of their randomized treatment (vaccine or placebo). Children, teenagers and adults will receive one dose of either the vaccine or placebo on Day 1 and the second dose of either the vaccine or placebo 3 months later. Up to 4 blood samples will be taken throughout the study.

During the study, participants will visit their study clinic 6 times.

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Detailed Description

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The vaccine being tested in this study is called TDV (Live, Attenuated). TDV is being tested to prevent dengue. This study will assess the safety and immunogenicity of TDV in healthy participants.

The study will enroll approximately 480 patients. Participants will be randomly assigned (by chance, like flipping a coin) to receive either TDV or placebo- which will remain undisclosed to the participant, and investigator during the study:

* Cohort 1, ≥18 to ≤60 Age Group: TDV
* Cohort 1, ≥18 to ≤60 Age Group: Placebo
* Cohort 2, ≥4 to \<18 Age Group: TDV
* Cohort 2, ≥4 to \<18 Age Group: Placebo

This multi-center trial will be conducted in India. The overall duration of the study is approximately 9 months.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1: ≥18 to ≤60 Age Group: TDV

Group Type EXPERIMENTAL

TDV

Intervention Type BIOLOGICAL

TDV SC injection on Day 1 and Day 90 of the study

Cohort 1: ≥18 to ≤60 Age Group: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Normal Saline (0.9% NaCl) SC injection on Day 1 and Day 90 of the study

Cohort 2: ≥4 to <18 Age Group: TDV

Group Type EXPERIMENTAL

TDV

Intervention Type BIOLOGICAL

TDV SC injection on Day 1 and Day 90 of the study

Cohort 2: ≥4 to <18 Age Group: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Normal Saline (0.9% NaCl) SC injection on Day 1 and Day 90 of the study

Interventions

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TDV

TDV SC injection on Day 1 and Day 90 of the study

Intervention Type BIOLOGICAL

Placebo

Normal Saline (0.9% NaCl) SC injection on Day 1 and Day 90 of the study

Intervention Type BIOLOGICAL

Other Intervention Names

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TAK-003

Eligibility Criteria

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Inclusion Criteria

1\. Participants who can comply with trial procedures and are available for the duration of follow-up.

Exclusion Criteria

At screening and at vaccination:

1. A body mass index (BMI) ≥35 kg/m\^2.
2. Intent to participate in another clinical trial at any time during the conduct of this trial.
3. Plans to receive any of the following:

1. A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to TDV or placebo administration.
2. A coronavirus vaccine within 14 days prior to TDV or placebo administration.
3. A vaccine authorized for emergency use within 28 days of TDV or placebo administration.
4. Known substance or alcohol abuse within the past 2 years that may interfere with his/her ability to comply with requirements for trial participation.
5. Receipt of previous vaccination against dengue virus.
6. Previous participation in any clinical trial of a dengue candidate vaccine.

At Vaccination:

1. Participants with febrile illness or moderate or severe acute illness, or infection, at the time of random assignment.
2. Participants medicated with antipyretic and/or analgesic medication(s) within 24 hours prior to TDV or placebo administration.

Minimum Eligible Age

4 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes