Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT06060067
Eligibility Criteria:
Key Inclusion Criteria:
1\. Participants who can comply with trial procedures and are available for the duration of follow-up.
Key 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.
NOTE: Other protocol defined Inclusion/exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
60 Years
Study:
NCT06060067
Study Brief:
Protocol Section:
NCT06060067