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Virus Vaccine

Dengue Vaccine for Dengue Fever

Phase 3
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female participants who received at least one dose of Takeda's tetravalent dengue vaccine candidate (TDV) in the parent trials (DEN-304 [(NCT03423173)] and DEN-315 [NCT03341637]) and have data from at least one blood draw post-vaccination.
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

Study Summary

This trial looks at antibody persistence for the dengue vaccine up to 36 months after the first vaccination, as well as the impact of a booster dose.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have received at least one dose of the TDV dengue vaccine in previous trials.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
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 more

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).

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,202 Previous Clinical Trials
4,177,897 Total Patients Enrolled
8 Trials studying Dengue Fever
5,000 Patients Enrolled for Dengue Fever
Study DirectorStudy DirectorTakeda
1,207 Previous Clinical Trials
489,315 Total Patients Enrolled
1 Trials studying Dengue Fever
200 Patients Enrolled for Dengue Fever
Medical DirectorStudy DirectorTakeda
2,777 Previous Clinical Trials
8,063,115 Total Patients Enrolled
22 Trials studying Dengue Fever
73,199 Patients Enrolled for Dengue Fever

Media Library

Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03999996 — Phase 3
Dengue Fever Research Study Groups: Placebo, Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)
Dengue Fever Clinical Trial 2023: Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Highlights & Side Effects. Trial Name: NCT03999996 — Phase 3
Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03999996 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the goals that researchers are hoping to achieve with this experiment?

"The primary outcome of this clinical trial will be monitored over approximately Month 16 and is the Geometric Mean Titers (GMTs) of Neutralizing Antibodies for each of the 4 Dengue Serotypes at Month 21. Additionally, secondary objectives include the Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes, which is defined as GMR of neutralizing antibodies calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at Baseline in the parent trials (DEN-304 and DEN"

Answered by AI

How many people are receiving care through this research project?

"As of 6/28/2021, this particular study is no longer actively recruiting patients. However, there are 26 other studies that you may be eligible for if you have dengue fever. Additionally, there are 6 TDV trials also seeking participants."

Answered by AI

Are there any open enrollment slots left for this research project?

"This specific trial is not currently looking for new patients, but there are other dengue fever studies with open enrollment. 26 clinical trials are actively recruiting participants and 6 of those studies specifically focus on the Tetravalent Dengue Vaccine (TDV)."

Answered by AI

Are there precedents for this kind of dengue fever vaccination?

"At the moment, there are 6 different clinical trials that are looking into Tetravalent Dengue Vaccine (TDV). Out of these six, two are in Phase 3. Most research surrounding TDV is based in Salvador, Bahia; however, there are 47 locations running clinical trials for this vaccine."

Answered by AI

Have there been other clinical trials like this one before?

"Tetravalent Dengue Vaccine (TDV) has been under clinical investigation since 2016. The first large-scale trial was sponsored by Takeda Pharmaceuticals in 2016 and involved 20,099 participants. After the initial success of the Phase 3 drug approval in 2016, there are currently 6 live studies for Tetravalent Dengue Vaccine (TDV) across 22 cities and 11 countries."

Answered by AI

Has the Tetravalent Dengue Vaccine (TDV) received certification from the FDA?

"There is both efficacy and safety data from Phase 3 clinical trials, so our team has given it a score of 3."

Answered by AI

Does this research study have an age limit for participants?

"According to the age parameters set out in the inclusion criteria, patients must be between 13 and 63 years old to participate."

Answered by AI

Are there different research facilities conducting this trial throughout the United States?

"There are 8 trial sites currently accepting patients, such as Heartland Research Associates LLC in Newton, Synexus Clinical Research US, Inc. - Omaha in Omaha, and Synexus Clinical Research US, Inc. - St. Louis in Saint Louis. There are also 8 other locations conducting this study."

Answered by AI

Are there specific requirements for volunteers in this experiment?

"Takeda's dengue fever clinical trial is looking for 365 between the ages of 13 and 63 that fit the following criteria: 1. Male or female participants (irrespective of serostatus at Baseline in the parent trials (DEN-304 [(NCT03423173)] and DEN-315 [NCT03341637]) who received at least one dose of Takeda's tetravalent dengue vaccine candidate (TDV) in the parent trials and have data from at least one blood draw post-vaccination.."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose
2019. "Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03999996.
~0 spots leftby May 2024
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