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Trial record 51 of 97 for:    "Dengue Hemorrhagic Fever"

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

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ClinicalTrials.gov Identifier: NCT03423173
Recruitment Status : Completed
First Posted : February 6, 2018
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment Phase
Dengue Fever Biological: TDV Biological: Placebo Phase 3

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 immune responses induced by 3 consecutive lots of TDV in healthy participants in non-endemic country(ies) for dengue.

The study will enroll approximately 924 healthy participants. Participants will be randomized in 2:2:2:1 to one of 4 trial groups to receive TDV (Lots 1, 2 or 3) or placebo:

  • TDV 0.5 mL subcutaneous injection OR
  • Placebo normal saline solution (0.9% NaCl) for injection.

In each trial group, all participants will receive 2 doses of TDV or placebo by subcutaneous injection on Days 1 (Month 0) and 90 (Month 3). Immunogenicity will be assessed in participants included in the immunogenicity subset (TDV groups: 176 participants each and placebo group: 88 participants) and safety will be assessed in all participants in each group.

This multi-center trial will be conducted in the United States. The overall time to participate in this study is 270 days. Participants will make multiple visits to the clinic including a final visit at Day 270.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 924 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: A double-blind study.
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : February 12, 2018
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : January 14, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arm Intervention/treatment
Experimental: TDV Lot 1
TDV, Lot 1, 0.5 mL, injection, subcutaneously (first dose), once on Day 1, followed by TDV, Lot 1, 0.5 mL, injection, subcutaneously, once on Day 90 (second dose).
Biological: TDV
TDV subcutaneous injection

Experimental: TDV Lot 2
TDV, Lot 2, 0.5 mL, injection, subcutaneously (first dose), once on Day 1, followed by TDV, Lot 2, 0.5 mL, injection, subcutaneously, once on Day 90 (second dose).
Biological: TDV
TDV subcutaneous injection

Experimental: TDV Lot 3
TDV, Lot 3, 0.5 mL, injection, subcutaneously (first dose), once on Day 1, followed by TDV, Lot 3, 0.5 mL, injection, subcutaneously, once on Day 90 (second dose).
Biological: TDV
TDV subcutaneous injection

Placebo Comparator: Placebo
Normal Saline (0.9% NaCl) 0.5 mL injection, subcutaneously (first dose), once on Day 1, followed by TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 90 (second dose).
Biological: Placebo
Normal Saline (0.9% NaCl) subcutaneous injection




Primary Outcome Measures :
  1. Geometric Mean Titers (GMTs) of Neutralizing Antibodies for each of the 4 Dengue Serotypes at Day 120 (in the Immunogenicity Subset) [ Time Frame: 1 month post second dose (Day 120) ]
    GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes will be measured by microneutralization test 50% [MNT50].


Secondary Outcome Measures :
  1. Percentage of Participants with Seropositivity for each of the 4 Dengue Serotypes at Days 120 and 270 (in the Immunogenicity Subset) [ Time Frame: 1 month post second dose (Day 120) and 6 months post second dose (Day 270) ]
    Seropositivity is defined as a reciprocal neutralizing titer ≥10.

  2. GMTs of Neutralizing Antibodies for each of the 4 Dengue Serotypes at Day 270 (in the Immunogenicity Subset) [ Time Frame: 6 months post second dose (Day 270) ]
    GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes will be measured by microneutralization test 50% [MNT50].

  3. Percentage of Participants with Solicited (Local Injection) Site Adverse Events (AEs) by Severity [ Time Frame: Days 1 through 7 after each vaccination ]
    Solicited local AEs (at injection site) include pain, erythema and swelling.

  4. Percentage of Participants with Solicited Systemic Adverse Events (AEs) by Severity [ Time Frame: Days 1 through 14 after each vaccination ]
    Solicited systemic AEs include fever, headache, asthenia, malaise and myalgia.

  5. Percentage of Participants with any Unsolicited Adverse Events (AEs) [ Time Frame: Up to 28 days (Day of Vaccination+27 Subsequent Days) after each TDV/Placebo dose on Day 1 and Day 90 ]
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration.

  6. Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: First dose (Day 1) up to 6 months post second dose (Day 270) ]
    A SAE is defined as any untoward medical occurrence or effect that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important which may require intervention to prevent the items listed above or may expose the participant to danger.

  7. Percentage of Participants with Medically Attended AEs (MAAEs) [ Time Frame: First dose (Day 1) up to 6 months post second dose (Day 270) ]
    MAAEs are defined as AEs leading to a medical visit to or by a healthcare professional, including visits to an emergency department, but not fulfilling seriousness criteria.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. 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 Criteria:

  1. Has an elevated oral temperature (≥38°C or 100.4°F) within 3 days of the intended date of vaccination.
  2. Known hypersensitivity or allergy to any of the vaccine components (including excipients of the investigational vaccine or placebo).
  3. Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome).
  4. Known or suspected impairment/alteration of immune function, including:

    1. 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)
    2. 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).
    3. Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial.
    4. Receipt of immunostimulants within 60 days prior to Day 1 (M0).
    5. Hepatitis C virus infection.
    6. Genetic immunodeficiency.
  5. Has abnormalities of splenic or thymic function.
  6. Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
  7. Has any serious chronic or progressive disease according to judgment of the Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
  8. Has body mass index (BMI) greater than or equal to 35 kg/m^2 (= weight in kg/[height in meters^2]).
  9. Has history of substance or alcohol abuse within the past 2 years.
  10. 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.
  11. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423173


Locations
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United States, Alabama
Optimal Research
Huntsville, Alabama, United States, 35802
United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92805
United States, Idaho
Advanced Clinical Research
Boise, Idaho, United States, 83704
United States, Illinois
Optimal Research
Peoria, Illinois, United States, 61614
United States, Iowa
Synexus Limited- Council Bluffs
Council Bluffs, Iowa, United States, 51503
United States, Kansas
Heartland Research Associates LLC - Augusta
Augusta, Kansas, United States, 67010
Heartland Research Associates LLC
Park City, Kansas, United States, 67219
United States, Maryland
Optimal Research
Rockville, Maryland, United States, 20850
United States, Minnesota
Synexus Limited - Minneapolis
Edina, Minnesota, United States, 55435
United States, Missouri
Synexus Limited - St. Louis
Saint Louis, Missouri, United States, 63141
United States, Nevada
Clinical Research Center of Nevada
Las Vegas, Nevada, United States, 89104
United States, Ohio
Synexus Limited - Columbus
Columbus, Ohio, United States, 43212
United States, Utah
Advanced Clinical Research
Salt Lake City, Utah, United States, 84123
Advanced Clinical Research
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Clinical Science Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03423173     History of Changes
Other Study ID Numbers: DEN-304
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:
Vaccine

Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Vaccines
Immunologic Factors
Physiological Effects of Drugs