Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose
Public ClinicalTrials.gov record NCT03999996. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Follow-Up Trial to Evaluate Long-Term Safety and Antibody Persistence, and the Impact of a Booster Dose of a Tetravalent Dengue Vaccine Candidate in Healthy Adolescents and Adults in Areas Non-Endemic for Dengue
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to describe antibody persistence for each of the 4 dengue serotypes for up to 63 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-315 (NCT03341637) (Mexico) and for up to 36 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-304 (NCT03423173) (United States \[US\]) and to describe the impact of a tetravalent dengue vaccine (TDV) booster dose vs placebo on antibody response for each of the 4 dengue serotypes at 1 month and 6 months post administration of the TDV booster or placebo.
Study identification
- NCT ID
- NCT03999996
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 365 participants
Conditions and interventions
Conditions
Interventions
- Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Biological
- Placebo Biological
Biological
Eligibility (public fields only)
- Age range
- 13 Years to 63 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 12, 2019 (Actual)
- Primary completion
- May 25, 2024 (Actual)
- Completion
- May 25, 2024 (Actual)
- Last update posted
- Jul 30, 2026
2019 – 2024
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AES - DRS - Optimal Research Alabama - Huntsville | Huntsville | Alabama | 35802 | — |
| AES - DRS - Optimal Research Illinois - Peoria | Peoria | Illinois | 61614 | — |
| Alliance for Multispecialty Research, LLC - Newton - PPDS | Newton | Kansas | 67114 | — |
| Optima Research | Rockville | Maryland | 20850 | — |
| AES - DRS - Synexus Clinical Research US, Inc. Minneapolis | Richfield | Minnesota | 55423-2590 | — |
| AES - DRS - Synexus Clinical Research US, Inc. - St. Louis | St Louis | Missouri | 63141 | — |
| AES - DRS - Synexus Clinical Research US, Inc. - Omaha | Papillion | Nebraska | 68046 | — |
| Advanced Clinical Research/Velocity Clinical Research | West Jordan | Utah | 84088-8865 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03999996, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 30, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03999996 live on ClinicalTrials.gov.