ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Participants

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: NCT02302066
Recruitment Status : Active, not recruiting
First Posted : November 26, 2014
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to assess the humoral immune responses to Takeda's Tetravalent Dengue Vaccine Candidate (TDV) administered subcutaneously in a subset of healthy participants between 2 and <18 years of age living in dengue endemic countries.

Condition or disease Intervention/treatment Phase
Dengue Fever Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Drug: TDV Placebo Phase 2

Detailed Description:

The vaccine being tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). TDV is being tested to assess how different dosing schedules of the vaccine effect immunity to dengue fever in dengue endemic countries. This study will look at the number of antibodies to dengue fever formed in people who are administered different dosing schedules of TDV.

The study will randomize approximately 1800 patients. Participants will be randomly assigned to one of the four treatment groups in a 1:2:5:1 ratio—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • Group 1 - TDV 0.5 mL subcutaneous (SC) injection Days 1 and 91
  • Group 2 - TDV 0.5 mL SC injection Day 1
  • Group 3 - TDV 0.5 mL SC injection Days 1 and 365
  • Placebo (dummy SC) - this is a liquid that looks like the study drug but has no active ingredient

In order to keep the treatment arms undisclosed to the patient and the doctor, participants will receive a placebo injection at any study visit where TDV is not being administered (Days 91 and/or 365).

Participants will be asked to record any symptoms that may be related to the vaccine or the injection site in a diary card for 28 days after each vaccination.

This multi-centre trial will be conducted in Asia and Latin America. The overall time to participate in this study is up to 18 months. Participants will make 7 visits to the clinic including a final visit 6 months after last dose of study drug for a follow-up assessment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase II, Double-Blind, Controlled Trial to Assess the Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Subjects Aged Between 2 and <18 Years and Living in Dengue Endemic Countries in Asia and Latin America
Actual Study Start Date : December 1, 2014
Estimated Primary Completion Date : July 12, 2019
Estimated Study Completion Date : July 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arm Intervention/treatment
Experimental: Group 1 (TDV 2-Dose)
Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Takeda's tetravalent dengue placebo, 0.5 mL, subcutaneous injection on Day 365.
Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)
TDV subcutaneous injection

Drug: TDV Placebo
Takeda's tetravalent dengue placebo-matching vaccine

Experimental: Group 2 (TDV 1-Dose)
Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Day 1. Takeda's tetravalent dengue placebo, 0.5 mL, subcutaneous injection on Days 91 and 365.
Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)
TDV subcutaneous injection

Drug: TDV Placebo
Takeda's tetravalent dengue placebo-matching vaccine

Experimental: Group 3 (TDV 1-Dose + Booster)
Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 365. Takeda's tetravalent dengue placebo, 0.5 mL, subcutaneous injection on Day 91.
Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)
TDV subcutaneous injection

Drug: TDV Placebo
Takeda's tetravalent dengue placebo-matching vaccine

Placebo Comparator: Group 4 (Placebo Control)
Takeda's tetravalent dengue placebo, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
Drug: TDV Placebo
Takeda's tetravalent dengue placebo-matching vaccine




Primary Outcome Measures :
  1. Geometric Mean Titers (GMTs) of neutralizing antibodies (microneutralization test [MNT50]) for each of the four DENV Serotypes [ Time Frame: Months 1, 3, 6, 12, 13, 18, 24, 36, and 48 ]
    The four DENV serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.


Secondary Outcome Measures :
  1. Seropositivity rates (%) for each of the four DENV serotypes where seropositivity (MNT50) is defined as a reciprocal neutralizing titer ≥ 10 [ Time Frame: Months 1, 3, 6, 12, 13, 18, 24, 36, and 48 ]
    Seropositivity is defined as a reciprocal neutralizing titer ≥ 10.

  2. Percentage of Participants with Solicited Local and Systemic Adverse Events (AEs) in the Immunogenicity Subset [ Time Frame: Days 7 and 14 after each vaccination ]
    Solicited local AEs at injection site are defined as pain, erythema and swelling. Solicited systemic AEs in infants/toddlers (15-24 months) and children (< 6 years) are defined as fever, irritability/fussiness, drowsiness and loss of appetite. Solicited systemic AEs in adults and children (≥ 6 years) are defined as fever, asthenia, headache, malaise and myalgia.

  3. Severity of Solicited Local and Systemic Adverse Events (AEs) in the Immunogenicity Subset [ Time Frame: Days 7 and 14 after each vaccination ]
    Solicited local AEs are defined as pain, erythema and swelling. Solicited systemic AEs in infants/toddlers (15-24 months) and children (< 6 years) are defined as fever, irritability/fussiness, drowsiness and loss of appetite. Solicited systemic AEs in adults and children (≥ 6 years) are defined as fever, asthenia, headache, malaise and myalgia.

  4. Percentage of Participants in the Immunogenicity Subset with Any Unsolicited Adverse Events (AEs) [ Time Frame: Day 28 after each vaccination ]
    Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.

  5. Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Day 540 ]
    A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose 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 due to other reasons than the above mentioned criteria.

  6. Percentage of Participants with Febrile Episodes of Virologically Confirmed Dengue [ Time Frame: Up to Day 540 ]
    Participants with febrile illness (defined as temperature ≥ 38°C on 2 consecutive days) will be evaluated for dengue. A dengue infection will be considered virologically confirmed by either positive polymerase chain reaction (PCR) or NS1 enzyme-linked immunosorbent assay (ELISA).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Is aged 2 to <18 years, at the time of enrollment
  2. Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator.
  3. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form (and assent form, where required) 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.
  4. Can comply with trial procedures and are available for the duration of follow-up.

Exclusion Criteria:

  1. Febrile illness (temperature ≥ 38°C or 100.4°F) or moderate or severe acute illness or infection at the time of enrollment. Trial entry should be delayed until the illness has improved.
  2. Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial, including but not limited to: a. Known hypersensitivity or allergy to any of the vaccine components; b. Female participants who are pregnant or breastfeeding; c. Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g. neoplasm, insulin-dependent diabetes, cardiac, renal or hepatic disease, neurologic or seizure disorder or Guillain-Barré syndrome); d. Known or suspected impairment/alteration of immune function, including: i. 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 (use of inhaled, intranasal, or topical corticosteroids is allowed); ii. 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; iii. Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the investigational vaccine or planned administration during the trial; iv. Receipt of immunostimulants within 60 days prior to Day 1; v. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months preceding (first) vaccination; vi. Human immunodeficiency virus (HIV) infection or HIV-related disease; vii. Genetic immunodeficiency.
  3. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of investigational vaccine administration.
  4. Individuals participating in any clinical trial with another investigational product 30 days prior to first trial visit or intent to participate in another clinical trial at any time during the conduct of this trial.
  5. Individuals who are first degree relatives of individuals involved in trial conduct.
  6. If female of childbearing potential, sexually active, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to trial entry: a. Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal (for at least 2 years), bilateral tubal ligation (at least 1 year previously), bilateral oophorectomy (at least 1 year previously) or hysterectomy; b. Acceptable birth control methods are defined as one or more of the following: i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring); ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse; iii. Intrauterine device (IUD); iv. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the participants' trial entry.
  7. If female of childbearing potential, sexually active and refuses to use an "acceptable contraceptive method" through to 6 weeks after the last dose of investigational vaccine.
  8. Individuals who participated in a previous dengue vaccine trial.

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): NCT02302066


Locations
Dominican Republic
Hospital Maternidad Nuestra Senora de la Altagracia
Santo Domingo, Dominican Republic, 10205
Panama
Centro De Vacunacion Internacional, S.A.(CEVAXIN)
Panama City, Panama, 10662
Philippines
Dela Salle Health Sciences Institute
Cavite, Philippines, 4114
Sponsors and Collaborators
Takeda
Investigators
Study Director: Program Medical Director Takeda

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02302066     History of Changes
Other Study ID Numbers: DEN-204
PHRR140804-000219 ( Registry Identifier: PHRR )
U1111-1154-2475 ( Registry Identifier: WHO )
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

Keywords provided by Takeda:
Drug therapy

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