Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose

Completed · Phase 3 · Has a placebo group

Conditions studied: Dengue Fever

In brief

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.

Key facts

Study ID

NCT03999996

Run by

Takeda

People needed

365

Starts

2019-11-12

Expected to finish

2024-05-25

Last updated by the study team

2026-07-30

Who can join

Age: 13 and older, up to 63. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Participants with a prolonged period of habitation (≥1 year) in a dengue endemic area within the 2 years prior to Visit 1 Day 1 (Month 0).
• 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.
• Booster Exclusion Criteria:
• Participants for whom baseline serostatus is not defined in the parent trials (DEN-304 [(NCT03423173)] and DEN-315 [NCT03341637]).
• Participants with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (eg, Guillain-Barré syndrome).
• Known or suspected impairment/alteration of immune function, including:
• 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.
• 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).
• 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.
• 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).
• 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).
• Known human immunodeficiency virus (HIV) infection or HIV-related disease.
• Hepatitis C virus infection.
• Genetic immunodeficiency.
• Abnormalities of splenic or thymic function.
• Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.