Dengue Clinical Trial
Official title:
A Randomized, Observer-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Immunogenicity and Safety of a Tetravalent Dengue Vaccine Candidate and a Yellow Fever YF-17D Vaccine Administered Concomitantly and Sequentially in Healthy Subjects Aged 18 to 60 Years in Non-Endemic Country(Ies)
The main purpose of this study is to assess the immunogenicity and safety of the concomitant and sequential administration of yellow fever (YF) vaccine and tetravalent dengue vaccine (TDV) in healthy participants aged 18 to 60 years living in country non-endemic for both dengue and YF.
The vaccine tested in this study is TDV also known as TAK-003 (DENVax). TDV with concomitant
and sequential administration of yellow fever (YF-17D) vaccine will be tested to assess
immunogenicity and safety in healthy adult participants in non-endemic area(s) for both
dengue and YF.
The study will enroll 900 healthy participants. Participants will be randomized to 3 groups
in 1:1:1 ratio and will be administered concomitantly and sequentially. The 3 groups are:
- Group 1: YF-17D vaccine + placebo concomitantly administered on Day 1, first dose of TDV
administered on Day 90 and second dose of TDV administered on Day 180.
- Group 2: first dose of TDV + placebo concomitantly administered on Day 1, second dose of
TDV administered on Day 90 and YF-17D vaccine administered on Day 180.
- Group 3: first dose of TDV + YF-17D vaccine concomitantly administered on Day 1, second
dose of TDV administered on Day 90 and placebo administered on Day 180.
This multi-center trial will be conducted in the United States. The overall time to
participate in this study is 360 days. Participants will make multiple visits to the clinic
with a 6-month follow up including a final visit at Day 360 for a follow-up assessment.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05321264 -
Educational Intervention to Promote Control Behaviors and Prevention of Dengue
|
N/A | |
| Completed |
NCT01436396 -
Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers
|
Phase 3 | |
| Completed |
NCT01391819 -
Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children
|
N/A | |
| Completed |
NCT03641339 -
Defining Skin Immunity of a Bite of Key Insect Vectors in Humans
|
N/A | |
| Completed |
NCT02833584 -
Safety of Paracetamol as Antipyretic in Treatment of Dengue Infection in Adults
|
N/A | |
| Completed |
NCT02433652 -
Evaluating the Safety and Protective Efficacy of a Single Dose of a Trivalent Live Attenuated Dengue Vaccine to Protect Against Infection With DENV-2
|
Phase 1 | |
| Enrolling by invitation |
NCT02016027 -
Pharmacological Effect of Carica Papaya Leaves Mother Tincture in Healthy Individuals Blood Parameter
|
Phase 1 | |
| Completed |
NCT01477671 -
Prospective Dengue Seroprevalence Study in 5 to 10 Year-old Children
|
N/A | |
| Recruiting |
NCT00377754 -
Prospective Study of Infant Dengue
|
N/A | |
| Recruiting |
NCT05919277 -
A Dengue Sero-prevalence Study in the Metropolitan Area of Buenos Aires
|
||
| Recruiting |
NCT04582474 -
Demonstration of an Electronic Clinical Decision Support Module for Dengue in Burkina Faso
|
N/A | |
| Completed |
NCT01983553 -
Long-Term Study of Hospitalized Dengue & Safety in Thai Children Included in a Tetravalent Dengue Vaccine Efficacy Study
|
||
| Completed |
NCT03803618 -
Dengue Effectiveness Study in the Philippines
|
||
| Active, not recruiting |
NCT05967455 -
Homologous Re-infection With Dengue 1 or Dengue 3
|
Phase 1 | |
| Completed |
NCT03631719 -
Impact of Wolbachia Deployment on Arboviral Disease Incidence in Medellin and Bello, Colombia
|
||
| Recruiting |
NCT02606019 -
The Use of Biomarkers in Predicting Dengue Outcome
|
N/A | |
| Completed |
NCT02372175 -
Assessment of a Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) Virus Strain
|
Phase 1 | |
| Active, not recruiting |
NCT01696422 -
Phase II Trial to Evaluate Safety and Immunogenicity of a Dengue 1,2,3,4 (Attenuated) Vaccine
|
Phase 2 | |
| Completed |
NCT00993447 -
Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America
|
Phase 2 | |
| Completed |
NCT00375726 -
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3/4delta30[ME]) in Healthy Adults
|
Phase 1 |