Status:
COMPLETED
Lot-to-lot Consistency of 3 Lots of Tetravalent Dengue Vaccine (TDV) in Non-endemic Country(Ies) for Dengue
Lead Sponsor:
Takeda
Conditions:
Dengue Fever
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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-...
Detailed Description
The vaccine tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). The primary objective of this trial is to investigate lot-to-lot consistency in terms of equivalence of the imm...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Had previous and planned vaccination (during the trial conduct) against any flavivirus including dengue, yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne encephalitis.
- Has a current or previous infection with a flavivirus such as dengue, Zika, YF, JE, West Nile (WN) fever, tick-borne encephalitis or Murray Valley encephalitis and participants with a history of prolonged (≥1 year) habitation in a dengue endemic area.
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2019
Estimated Enrollment :
923 Patients enrolled
Trial Details
Trial ID
NCT03423173
Start Date
February 12 2018
End Date
January 14 2019
Last Update
October 20 2020
Active Locations (14)
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1
Optimal Research
Huntsville, Alabama, United States, 35802
2
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92805
3
Advanced Clinical Research
Boise, Idaho, United States, 83704
4
Optimal Research
Peoria, Illinois, United States, 61614