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

Who is this study for? Patients with Dengue Fever
What treatments are being studied? Tetravalent Dengue Vaccine (TDV)
Status: Completed
Location: See all (10) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 63
Healthy Volunteers: t
View:

• 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.

Locations
United States
Alabama
AES - DRS - Optimal Research Alabama - Huntsville
Huntsville
Illinois
AES - DRS - Optimal Research Illinois - Peoria
Peoria
Kansas
Alliance for Multispecialty Research, LLC - Newton - PPDS
Newton
Maryland
Optima Research
Rockville
Minnesota
AES - DRS - Synexus Clinical Research US, Inc. Minneapolis
Richfield
Missouri
AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
St Louis
Nebraska
AES - DRS - Synexus Clinical Research US, Inc. - Omaha
Papillion
Utah
Advanced Clinical Research/Velocity Clinical Research
West Jordan
Other Locations
Mexico
CAIMED Investigacion en Salud S.A de C.V.
Mexico City
Instituto Nacional de Pediatria
Mexico City
Time Frame
Start Date: 2019-11-12
Completion Date: 2024-05-25
Participants
Target number of participants: 365
Treatments
Experimental: 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.
Experimental: 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.
Placebo_comparator: 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).
Experimental: 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).
Related Therapeutic Areas
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov

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