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

Phase 1

• Conditions: Dengue; MedDRA version: 20.1Level: PTClassification code 10012310Term: Dengue feverSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2023-000134-15-Outside-EU/EEA
• Lead Sponsor: Takeda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-22
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Participants who can comply with trial procedures and are available for the duration of follow-up.
Are the trial subjects under 18? yes
Number of subjects for this age range: 240
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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:
a. A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to TDV or placebo administration.
b. A coronavirus vaccine within 14 days prior to TDV or placebo administration.
c. 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. Medicated with antipyretic and/or analgesic medication(s) within 24 hours prior to TDV or placebo administration.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified