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Trial record 4 of 25 for:    Recruiting, Not yet recruiting, Available Studies | "Dengue"

Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) in Adolescents in Non-Endemic Area(s)

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ClinicalTrials.gov Identifier: NCT03341637
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this study is to describe the neutralizing antibody response against each dengue serotype at 1 month post second dose of TDV or placebo in dengue-naive adolescent participants.

Condition or disease Intervention/treatment Phase
Dengue Biological: Tetravalent Dengue Vaccine (TDV) Biological: Placebo Phase 3

Detailed Description:

The vaccine tested in this study is tetravalent dengue vaccine (TDV). TDV will be tested to assess the safety and immunogenicity in healthy adolescents in non-endemic area(s) for dengue.

The study will enroll 400 healthy participants. Participants will be randomized in 3:1 ratio to receive:

  • 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-dose schedule of TDV or placebo by subcutaneous injection on Days 1 (Month 0) and 90 (Month 3).

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Immunogenicity and Safety of Subcutaneous Administration of a Tetravalent Dengue Vaccine Candidate in Healthy Adolescent Subjects in Non-Endemic Area(s) for Dengue
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : June 16, 2018
Estimated Study Completion Date : November 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arm Intervention/treatment
Experimental: Tetravalent Dengue Vaccine (TDV)
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose)
Biological: Tetravalent Dengue Vaccine (TDV)
TDV subcutaneous injection

Placebo Comparator: Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and 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 [ Time Frame: 1 month post second dose (Day 120) ]
    GMTs of neutralizing antibodies will be measured by microneutralization test [MNT50] 50% for each of the 4 Dengue Serotypes. The 4 Wild type dengue virus serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.


Secondary Outcome Measures :
  1. Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 [ Time Frame: 6 months post second dose (Day 270) ]
    GMTs of neutralizing antibodies will be measured by microneutralization test [MNT50] 50% for each of the 4 Dengue Serotypes. The 4 Wild type dengue virus serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.

  2. Percentage of Participants with Seropositivity for Each of the 4 Dengue Serotypes [ Time Frame: 1 month post second dose (Day 120) and 6 months post second dose (Day 270) ]
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 Wild type dengue virus serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.

  3. Percentage of Participants with Seropositivity for Multiple (2, 3 or 4) Dengue Serotypes [ Time Frame: 1 Month Post Second Dose (Day 120) and 6 Months Post Second Dose (Day 270) ]
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10.

  4. 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 are defined as pain, erythema and swelling that occurred within 7 days after each vaccination.

  5. Percentage of Participants with Solicited Systemic Adverse Events (AEs) by Severity [ Time Frame: Days 1 through 14 after each vaccination ]
    Solicited systemic AEs are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination.

  6. 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 drug; it does not necessarily have to have a causal relationship with this treatment.

  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.

  8. 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 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.



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The participant is aged 12 to 17 years, inclusive;
  2. 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.
  3. The participant/the participant's legally authorized representative (LAR) signs and dates a written, informed consent/assent 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.
  4. Individuals who can comply with trial procedures and are available for the duration of follow-up.

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.
  3. Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the trial.
  4. Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barre syndrome).
  5. 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 subject due to participation in the trial.
  6. Has 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 immune-stimulants within 60 days prior to Day 1 (M0).
    5. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (M0).
    6. Human immunodeficiency virus (HIV) infection or HIV-related disease.
    7. Genetic immunodeficiency.
  7. Has abnormalities of splenic or thymic function.
  8. Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding.
  9. Has any serious chronic or progressive disease according to judgment of the Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
  10. Has body mass index (BMI) greater than or equal to 35 kg/m^2 (= weight in kg/[height in square meters]).
  11. Individuals participating in any clinical trial with another investigational product 30 days prior to Day 1 (M0) or intent to participate in another clinical trial at any time during the conduct of this trial.
  12. Has received any other vaccine 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 trial vaccine administration.
  13. Individuals involved in the trial conduct or their first degree relatives.
  14. Has history of substance or alcohol abuse within the past 2 years.
  15. Female participants who are pregnant or breastfeeding.
  16. Females of childbearing potential who are sexually active, and who have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1 (M0).
  17. Females of childbearing potential who are sexually active, and who refuse to use an acceptable contraceptive method up to 6 weeks after the last dose of trial vaccine. In addition, they must be advised not to donate ova during this period.
  18. Any positive or indeterminate pregnancy test.
  19. Previous and planned vaccination (during the trial conduct), against any flaviviruses including dengue, yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne encephalitis.
  20. Previous participation in any clinical trial of a dengue or other flavivirus (e.g.,eg, West Nile [WN] virus) candidate vaccine, except for participantssubjects who received placebo in those trials.
  21. Participants with documented or suspected disease caused by a flavivirus such as dengue, Zika, YF, JE, WN fever, tick-borne encephalitis or Murray Valley encephalitis.

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): NCT03341637


Contacts
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

Locations
Mexico
Biodextra, S.A. de C.V. Recruiting
Ciudad de Mexico, Mexico, 09360
Instituto Nacional de Pediatria (INP) Recruiting
Mexico City, Mexico, 04530
Hospital Infantil de Mexico Federico Gomez Recruiting
Mexico City, Mexico, 06720
Mexico Centre for Clinical Research Recruiting
Mexico City, Mexico, ZC 03100
Centro de Atencion E Investigacion Medica (CAIMED) Mexico DF Recruiting
Mexico City, Mexico
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Clinical Science Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03341637     History of Changes
Other Study ID Numbers: DEN-315
U1111-1192-7827 ( Other Identifier: World Health Organization )
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

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

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