Lot-to-lot Consistency of 3 Lots of Tetravalent Dengue Vaccine (TDV) in Non-endemic Country(Ies) for Dengue
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Demonstrate Lot-to-Lot Consistency of 3 Lots of a Tetravalent Dengue Vaccine Candidate in Healthy Adults in Non-Endemic Country(Ies) for Dengue
1 other identifier
interventional
923
1 country
14
Brief Summary
The purpose of this study is to investigate lot-to-lot consistency in terms of equivalence of the immune responses induced by 3 consecutive TDV lots in healthy participants aged 18 to 60 years in non-endemic country(ies) for dengue.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2018
Shorter than P25 for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2018
CompletedFirst Posted
Study publicly available on registry
February 6, 2018
CompletedStudy Start
First participant enrolled
February 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2019
CompletedResults Posted
Study results publicly available
October 20, 2020
CompletedOctober 20, 2020
October 1, 2020
6 months
January 31, 2018
September 11, 2020
October 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset
GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes was measured by microneutralization test 50% \[MNT50\]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
1 month post second dose (Day 120)
Secondary Outcomes (7)
Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset
1 month post second dose (Day 120) and 6 months post second dose (Day 270)
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset
6 months post second dose (Day 270)
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination
Within 7 Days of each Vaccination (day of vaccination + 6 days)
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination
Within 14 Days of each Vaccination (day of vaccination + 13 days)
Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination
Within 28 days (day of vaccination + 27 days) after each vaccination
- +2 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORTDV placebo matching injection, subcutaneously (SC) once on Day 1, and Day 90.
TDV Lot 1
EXPERIMENTALParticipants were administered TDV lot 1, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90.
TDV Lot 2
EXPERIMENTALParticipants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90.
TDV Lot 3
EXPERIMENTALParticipants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90.
Interventions
Eligibility Criteria
You may qualify if:
- Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and the clinical judgment of the Investigator.
- Signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
You may not qualify if:
- Has an elevated oral temperature (≥38°C or 100.4°F) within 3 days of the intended date of vaccination.
- Known hypersensitivity or allergy to any of the vaccine components (including excipients of the investigational vaccine or placebo).
- Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., 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 Day 1 (M0) (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 Day 1 (M0).
- Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial.
- Receipt of immunostimulants within 60 days prior to Day 1 (M0).
- Hepatitis C virus infection.
- Genetic immunodeficiency.
- Has abnormalities of splenic or thymic function.
- Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Has any serious chronic or progressive disease according to judgment of the Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
- Has body mass index (BMI) greater than or equal to 35 kg/m\^2 (= weight in kg/\[height in meters\^2\]).
- Has history of substance or alcohol abuse within the past 2 years.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (14)
Optimal Research
Huntsville, Alabama, 35802, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92805, United States
Advanced Clinical Research
Boise, Idaho, 83704, United States
Optimal Research
Peoria, Illinois, 61614, United States
Synexus Limited- Council Bluffs
Council Bluffs, Iowa, 51503, United States
Heartland Research Associates LLC - Augusta
Augusta, Kansas, 67010, United States
Heartland Research Associates LLC
Park City, Kansas, 67219, United States
Optimal Research
Rockville, Maryland, 20850, United States
Synexus Limited - Minneapolis
Edina, Minnesota, 55435, United States
Synexus Limited - St. Louis
St Louis, Missouri, 63141, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104, United States
Synexus Limited - Columbus
Columbus, Ohio, 43212, United States
Advanced Clinical Research
Salt Lake City, Utah, 84123, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Related Publications (2)
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.
PMID: 40099800DERIVEDTricou V, Winkle PJ, Tharenos LM, Rauscher M, Escudero I, Hoffman E, LeFevre I, Borkowski A, Wallace D. Consistency of immunogenicity in three consecutive lots of a tetravalent dengue vaccine candidate (TAK-003): A randomized placebo-controlled trial in US adults. Vaccine. 2023 Nov 13;41(47):6999-7006. doi: 10.1016/j.vaccine.2023.09.049. Epub 2023 Oct 24.
PMID: 37884415DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- A double-blind study.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2018
First Posted
February 6, 2018
Study Start
February 12, 2018
Primary Completion
August 3, 2018
Study Completion
January 14, 2019
Last Updated
October 20, 2020
Results First Posted
October 20, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.