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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 4 in the parent trials vs 1 and 6 months post-booster dose in the current trial; month 15 (us)/month 42 (mexico) vs 1 month post-booster dose; month 15 (us)/month 42 (mexico) vs 6 month post-booster dose; 1 vs 6 month post-booster dose
Awards & highlights
Pivotal Trial
Summary
This trial studies how long immunity lasts and the effect of a booster dose of a dengue vaccine in healthy adolescents and adults who participated in previous studies. The vaccine uses weakened viruses to help the body build defenses against dengue fever. It has shown strong initial protection but there are concerns about long-term immunity and safety.
Who is the study for?
This trial is for men and women who participated in previous dengue vaccine trials (DEN-304 or DEN-315) and received at least one dose of Takeda's TDV. They must have had a blood test after vaccination. People living in dengue areas for over a year recently, or vaccinated against related viruses like yellow fever, can't join.
What is being tested?
The study tests the long-term safety of Takeda's Dengue Vaccine (TDV) and how well it keeps working up to 63 months after first getting it. It also looks at whether a booster shot increases protection against all four types of dengue virus compared to a placebo.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to the TDV vaccine or booster dose as part of assessing its long-term safety.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 4 in the parent trials vs 1 and 6 months post-booster dose in the current trial; month 15 (us)/month 42 (mexico) vs 1 month post-booster dose; month 15 (us)/month 42 (mexico) vs 6 month post-booster dose; 1 vs 6 month post-booster dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 4 in the parent trials vs 1 and 6 months post-booster dose in the current trial; month 15 (us)/month 42 (mexico) vs 1 month post-booster dose; month 15 (us)/month 42 (mexico) vs 6 month post-booster dose; 1 vs 6 month post-booster dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Month 16 (US)
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Month 43 (Mexico)
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Month 21 (US)
+21 moreSecondary study objectives
GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes Post-booster Dose
Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for all Participants Prior to the Booster Dose
Percentage of Participants with Solicited Local Injection Site Adverse Events (AEs) by Severity, Post-booster Dose
+5 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)Experimental Treatment1 Intervention
TDV 0.5 mL, injection, subcutaneously, once at Month 15 for participants from parent trials DEN-304 (US) or once at Month 42 for participants from parent trial DEN-315 (Mexico).
Group II: PlaceboPlacebo Group1 Intervention
TDV placebo-matching 0.5 mL injection, subcutaneously, once at Month 15 for participants from parent trial DEN-304 (US) or once at Month 42 for participants from parent trial DEN-315 (Mexico).
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The Tetravalent Dengue Vaccine (TDV) Booster Dose works by stimulating the immune system to produce antibodies against all four dengue serotypes, providing broad protection against the virus. This is crucial for Dengue Fever patients as it helps prevent severe disease and complications associated with infection by different serotypes.
Other common treatments for Dengue Fever primarily focus on supportive care, such as fluid replacement to manage dehydration and pain relievers to reduce fever and discomfort. These treatments are essential to maintain patient stability and prevent severe outcomes like dengue hemorrhagic fever or dengue shock syndrome.
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Who is running the clinical trial?
TakedaLead Sponsor
1,233 Previous Clinical Trials
4,147,861 Total Patients Enrolled
10 Trials studying Dengue Fever
15,800 Patients Enrolled for Dengue Fever
Study DirectorStudy DirectorTakeda
1,267 Previous Clinical Trials
503,720 Total Patients Enrolled
3 Trials studying Dengue Fever
11,000 Patients Enrolled for Dengue Fever
Medical DirectorStudy DirectorTakeda
2,864 Previous Clinical Trials
8,082,110 Total Patients Enrolled
22 Trials studying Dengue Fever
73,199 Patients Enrolled for Dengue Fever
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not and will not receive any flavivirus vaccines, except Takeda's TDV, during the trial.I have received at least one dose of the TDV dengue vaccine in previous trials.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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