Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose
NCT ID: NCT03999996
Last Updated: 2025-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
365 participants
INTERVENTIONAL
2019-11-12
2024-05-25
Brief Summary
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Detailed Description
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The study has enrolled 365 healthy participants. Participants who previously received TDV in two parent trials (DEN-304 \[NCT03423173\] and DEN-315 \[NCT03341637\]), will be invited to participate in this follow-up trial. Participants will be assessed for antibody persistence and safety from Baseline (Month 0) through Month 15 (for participants from parent trial DEN-304 \[US\]) or Month 42 (for participants from parent trial DEN-315 \[Mexico\]). At Month 15 (for participants from parent trial DEN-304 \[US\]) or at Month 42 (for participants from parent trial DEN-315 \[Mexico\]), eligible participants will be randomized in 1:1 ratio to one of two trial groups to receive TDV or placebo:
A. Group 1- TDV 0.5 mL subcutaneous (SC) injection at Month 15 for participants from parent trial DEN-304 (US) or at Month 42 for participants from parent trial DEN-315 (Mexico\]).
B. Group 2- Takeda's tetravalent dengue placebo (dummy SC injection - this is a liquid that looks like the study drug but has no active ingredient), 0.5 mL, subcutaneous injection at Month 15 for participants from parent trial DEN-304 (US) or at Month 42 for participants from parent trial DEN-315 (Mexico).
This multi-centre trial will be conducted in US and Mexico. The overall time to participate in this study is up to 21 months for parent trial DEN-304 (US) and up to 48 months for parent trial DEN-315 (Mexico). Participants from parent trial DEN-304 (US) and participants from parent trial DEN-315 (Mexico) will come for 5 visits to the clinic which includes a final visit (Visit 5) 6 months after the booster dose for a follow-up assessment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Prior to Booster: DEN-304
Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Month 15.
Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)
TDV subcutaneous injection
Prior to Booster: DEN-315
Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Month 42.
Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)
TDV subcutaneous injection
Booster Phase: Placebo
Participants received TDV placebo-matching 0.5 milliliters (ml) injection, subcutaneous (SC), 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).
Placebo
Normal Saline (0.9% NaCl) subcutaneous injection
Booster Phase: TDV
Participants received TDV 0.5 ml, injection, SC, 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).
Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)
TDV subcutaneous injection
Interventions
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Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)
TDV subcutaneous injection
Placebo
Normal Saline (0.9% NaCl) subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Previous and planned vaccination (during the trial conduct), against any flavivirus including dengue (other than Takeda's TDV), yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne encephalitis.
1. Participants for whom baseline serostatus is not defined in the parent trials (DEN-304 \[(NCT03423173)\] and DEN-315 \[NCT03341637\]).
2. Participants with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (eg, Guillain-Barré syndrome).
3. Known or suspected impairment/alteration of immune function, including:
1. Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Month 42 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US); use of inhaled, intranasal, or topical corticosteroids is allowed.
2. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Month 42 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US).
3. Administration of immunoglobulins and/or any blood products within the 3 months prior to administration of the TDV booster or placebo at Month 42 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US); consider whether applicable as an exclusion criterion or criterion for delay.
4. Receipt of immunostimulants within 60 days prior to Month 42 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US).
5. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Month 42 for participants from parent trial DEN-315 (Mexico) / Month 15 for participants from parent trial DEN-304 (US).
6. Known human immunodeficiency virus (HIV) infection or HIV-related disease.
7. Hepatitis C virus infection.
8. Genetic immunodeficiency.
4. Abnormalities of splenic or thymic function.
5. Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
6. Participants with history of current or previous infection with a flavivirus such as dengue, Zika, YF, JE, West Nile fever, tick-borne encephalitis or Murray Valley encephalitis and participants with a prolonged period of habitation (≥1 year) in a dengue endemic area during trial conduct.
13 Years
63 Years
ALL
Yes
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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AES - DRS - Optimal Research Alabama - Huntsville
Huntsville, Alabama, United States
AES - DRS - Optimal Research Illinois - Peoria
Peoria, Illinois, United States
Alliance for Multispecialty Research, LLC - Newton - PPDS
Newton, Kansas, United States
Optima Research
Rockville, Maryland, United States
AES - DRS - Synexus Clinical Research US, Inc. Minneapolis
Richfield, Minnesota, United States
AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
St Louis, Missouri, United States
AES - DRS - Synexus Clinical Research US, Inc. - Omaha
Papillion, Nebraska, United States
Advanced Clinical Research/Velocity Clinical Research
West Jordan, Utah, United States
Instituto Nacional de Pediatria
Mexico City, , Mexico
CAIMED Investigacion en Salud S.A de C.V.
Mexico City, , Mexico
Countries
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References
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Rauscher M, Youard Z, Faccin A, Patel SS, Pang H, Zent O. Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. Expert Rev Vaccines. 2025 Dec;24(1):221-229. doi: 10.1080/14760584.2025.2480297. Epub 2025 Mar 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain more information about this study, click this link.
Other Identifiers
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2023-000027-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DEN-303
Identifier Type: -
Identifier Source: org_study_id
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