Lot-to-lot Consistency of 3 Lots of Tetravalent Dengue Vaccine (TDV) in Non-endemic Country(Ies) for Dengue

Completed · Phase 3 · Has a placebo group

Conditions studied: Dengue Fever

In brief

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.

Key facts

Study ID

NCT03423173

Run by

Takeda

People needed

923

Starts

2018-02-12

Expected to finish

2019-01-14

Last updated by the study team

2020-10-20

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

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.
• 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.

Where it is running

• Optimal Research — Huntsville, Alabama, United States
• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Advanced Clinical Research — Boise, Idaho, United States
• Optimal Research — Peoria, Illinois, United States
• Synexus Limited- Council Bluffs — Council Bluffs, Iowa, United States
• Heartland Research Associates LLC - Augusta — Augusta, Kansas, United States
• Heartland Research Associates LLC — Park City, Kansas, United States
• Optimal Research — Rockville, Maryland, United States
• Synexus Limited - Minneapolis — Edina, Minnesota, United States
• Synexus Limited - St. Louis — St Louis, Missouri, United States
• Clinical Research Center of Nevada — Las Vegas, Nevada, United States
• Synexus Limited - Columbus — Columbus, Ohio, United States
• Advanced Clinical Research — Salt Lake City, Utah, United States
• Advanced Clinical Research — West Jordan, Utah, United States

Full record on ClinicalTrials.gov

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