A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults (NCT07047521) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults
Australia496 participantsStarted 2025-11-07
Plain-language summary
Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. The TDV in current formulation has been approved by health authorities in many countries around the world. The main aim of the study is to confirm that the TDV new formulation induces the similar immune response as approved TDV.
Healthy adults who live in an area in which dengue fever does not occur will receive 2 TDV vaccinations 3-months apart with either the new or the current TDV. Blood samples will be taken before and after the vaccinations. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 5 times.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Chronic administration of oral and/or parenteral steroids at doses considered sufficiently immunosuppressive (example, greater than and equal to \[\>=\] 2 milligrams per kilograms \[mg/kg\] body weight/day prednisone \[or equivalent\] for \>=14 consecutive days or \>=20 mg/day prednisone \[or equivalent\] administered for \>=14 consecutive days) within 60 days prior to Day 1 (Month \[M\] 0) (note: use of corticosteroids by inhaled, intranasal, intra-articular, bursal, tendon injection, or topical routes is allowed).
. Receipt of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial.
. Receipt of immunostimulants within 60 days prior to Day 1 (M0).
. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (M0).
. Human immunodeficiency virus (HIV) infection or HIV-related disease.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Geometric Mean Titers (GMTs) of Neutralizing Antibodies (By MNT) Against Each of the 4 Dengue Serotypes at Day 120 In the TDV (New) And TDV (Current) Groups