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Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03771963
Recruitment Status : Active, not recruiting
First Posted : December 11, 2018
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE December 10, 2018
First Posted Date  ICMJE December 11, 2018
Last Update Posted Date June 21, 2019
Actual Study Start Date  ICMJE March 28, 2019
Estimated Primary Completion Date October 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 120 (Month 4) [ Time Frame: Day 120 (Month 4) ]
GMTs of neutralizing antibodies for each of the 4 dengue serotypes will be measured by microneutralization test 50% (MNT50).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03771963 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
  • Percentage of Participants with Seropositivity for Each of the Four Dengue Serotypes at Day 120 (Month 4) and Day 270 (Month 9) [ Time Frame: Days 120 (Month 4) and 270 (Month 9) ]
    Seropositivity is defined as a reciprocal neutralizing titer ≥10.
  • Percentage of Participants with Seropositivity for Each of the Multiple (2, 3 or 4) Dengue Serotypes at Day 120 (Month 4) and Day 270 (Month 9) [ Time Frame: Days 120 (Month 4) and 270 (Month 9) ]
    Seropositivity is defined as a reciprocal neutralizing titer ≥10.
  • Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 270 (Month 9) [ Time Frame: Day 270 (Month 9) ]
    GMTs of neutralizing antibodies for each of the 4 dengue serotypes will be measured by MNT50.
  • Percentage of Participants with Solicited Local (Injection Site) Reactions Following Vaccination by Severity [ Time Frame: Within 7 days after each of the vaccination given on Day 1 (Month 0) or 90 (Month 3) ]
    Solicited local Adverse Events (AEs) (at injection site) will be collected by participants using diary cards within 7 days after vaccination and will include injection site pain [Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)], injection site erythema [Grade 0 (<25 mm), 1 (25 − ≤ 50 mm), 2 (>50 − ≤ 100 mm), 3 (> 100 mm)] and injection site swelling [Grade 0 (<25 mm), 1 (25 − ≤ 50 mm), 2 (>50 − ≤ 100 mm), 3 (> 100 mm)].
  • Percentage of Participants with Solicited Systemic Adverse Events Following Vaccination by Severity [ Time Frame: Within 14 days after each of the vaccination given on Day 1 (Month 0) or 90 (Month 3) ]
    Solicited systemic AEs will be collected by participants using diary cards within 14 days after vaccination and will include fever, headache, asthenia, malaise and myalgia. Severity grades were: Grade 0: none, Grade 1: mild (no interference with daily activity), Grade 2: moderate (interference with daily activity with or without treatment), Grade 3: severe (prevents normal daily activity with or without treatment). Fever is defined as body temperature greater than or equal to 38°C (100.4°F).
  • Percentage of Participants with any Unsolicited Adverse Events (AEs) Following Vaccination [ Time Frame: Within 28 days after each of the vaccination given on Day 1 (Month 0) or 90 (Month 3) ]
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a study vaccine; it does not necessarily have to have a causal relationship with study vaccine administration.
  • Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: From first vaccination (Day 1) through end of study (Day 270 [Month 9]) ]
    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.
  • Percentage of Participants With Medically Attended AEs (MAAEs) [ Time Frame: From first vaccination (Day 1) through end of study (Day 270 [Month 9]) ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults
Official Title  ICMJE An Open-Label, Phase 3 Trial to Investigate the Immunogenicity and Safety of Tetravalent Dengue Vaccine Candidate (TDV) at the End of Shelf Life in Healthy Adults in Non-Endemic Country(Ies) for Dengue
Brief Summary The purpose of this study is to evaluate the safety and immune response of a naturally aged lot of tetravalent dengue vaccine (TDV) in healthy participants, aged 18 to 60 years, in non-endemic country(ies) for dengue.
Detailed Description

The vaccine being tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). The primary objective of this study is to evaluate the immune response and safety of a naturally aged (>12 months stored at 2°C to 8°C) lot of TDV in a healthy adult population in country(ies) non-endemic for dengue. The assessment of a naturally aged lot of TDV in this clinical trial will provide an important contribution to data on TDV stability throughout the shelf life of the product.

The study will enroll approximately 200 patients. Participants will be enrolled to the one treatment group:

TDV 0.5 mL

All participants will receive subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3).

This multi-center trial will be conducted in the United States. The overall time to participate in this study is 9 months. Participants will make multiple visits to the clinic including a final visit at Day 270 (Month 9).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Dengue Fever
Intervention  ICMJE Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)
TDV subcutaneous injection
Study Arms  ICMJE Experimental: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) 0.5 mL
TDV 0.5 ml, injection, subcutaneously (SC), once on Day 1 (Month 0) (dose 1) followed by TDV 0.5 ml, injection, SC once on Day 90 (Month 3) (dose 2).
Intervention: Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 10, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 16, 2020
Estimated Primary Completion Date October 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participants who are 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. Participants who sign and date 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. Participants with a clinically significant active infection (as assessed by the investigator) or body temperature ≥38°C (≥100.4°F) within 3 days of the intended date of vaccine administration
  2. Known or suspected impairment/alteration of immune function, including:

    1. Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks and/or ≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (Month 0) (use of inhaled, intranasal, or topical corticosteroids is allowed).
    2. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks and/or ≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (Month 0).
    3. Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (Month 0) or planned administration during the trial.
    4. Receipt of immunostimulants within 60 days prior to Day 1 (Month 0).
    5. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (Month 0).
    6. Known Human Immunodeficiency Virus (HIV) infection or HIV-related disease.
    7. Hepatitis C virus infection.
    8. Genetic immunodeficiency.
  3. With Body Mass Index (BMI) greater than or equal to 35 kg/m^2(=weight in kg/height in meters^2).
  4. Participants who have known hypersensitivity or allergy to any of the vaccine components.
  5. Previous and planned vaccination (during the trial conduct), against any flavivirus including dengue, Yellow Fever (YF), Japanese Encephalitis (JE) viruses or tick-borne encephalitis.
  6. Previous participation in any clinical trial of a dengue or other flavivirus (eg, West Nile [WN] virus) candidate vaccine, except for participants who received placebo in those trials.
  7. With a current or previous infection with a flavivirus such as dengue, Zika, YF, JE,WN fever, tick-borne encephalitis or Murray Valley encephalitis and participants with a history of prolonged (≥1 year) habitation in a dengue endemic area.
  8. Participants with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome).
  9. Participants with history of substance or alcohol abuse within the past 2 years.
  10. Participants who have any serious chronic or progressive disease according to judgment of the Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03771963
Other Study ID Numbers  ICMJE DEN-307
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Clinical Science Takeda
PRS Account Takeda
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP