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History of Changes for Study: NCT03771963
Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults
Latest version (submitted May 11, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 10, 2018 None (earliest Version on record)
2 March 20, 2019 Study Status
3 June 11, 2019 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 June 20, 2019 Recruitment Status, Study Status and Contacts/Locations
5 November 20, 2019 Study Status and Study Design
6 April 6, 2020 Recruitment Status and Study Status
7 October 12, 2020 Study Status
8 May 11, 2021 Study Status, Outcome Measures, Arms and Interventions, IPDSharing, More Information, Document Section, Adverse Events, Baseline Characteristics, Participant Flow, Contacts/Locations, Eligibility, Conditions, Study Description and Study Identification
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Study NCT03771963
Submitted Date:  December 10, 2018 (v1)
Open or close this module Study Identification
Unique Protocol ID: DEN-307
Brief Title: Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults
Official Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2018
Overall Status: Not yet recruiting
Study Start: March 15, 2019
Primary Completion: October 14, 2019 [Anticipated]
Study Completion: December 20, 2019 [Anticipated]
First Submitted: December 10, 2018
First Submitted that
Met QC Criteria:		 December 10, 2018
First Posted: December 11, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:		 December 10, 2018
Last Update Posted: December 11, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Takeda
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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).
Open or close this module Conditions
Conditions: Dengue Fever
Keywords: Vaccine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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).
 Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)
TDV subcutaneous injection
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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).
Secondary Outcome Measures:
1. 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.
2. 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.
3. 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.
4. 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)].
5. 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).
6. 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.
7. 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.
8. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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).
Open or close this module Contacts/Locations
Central Contact Person: Takeda Study Registration Call Center
Telephone: +1-877-825-3327
Email: medicalinformation@tpna.com
Study Officials: Medical Director Clinical Science
Study Director
Takeda
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
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.
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services