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    Summary
    EudraCT Number:2017-001071-23
    Sponsor's Protocol Code Number:DEN-314
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-11-21
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2017-001071-23
    A.3Full title of the trial
    A Randomized, Observer Blind, Phase 3 Trial to Investigate the Immunogenicity and Safety of the Co-administration of a Subcutaneous Tetravalent Dengue Vaccine Candidate (TDV) and an Intramuscular Hepatitis A Virus (Inactivated) Vaccine in Healthy Subjects Aged 18 to 60 Years in a Non-endemic Country(ies) for Dengue
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to investigate the immunogenicity and safety of the Dengue vaccine (TDV) when it is injected together with Hepatitis A vaccine in healthy adult subjects
    A.3.2Name or abbreviated title of the trial where available
    Immunogenicity and Safety of TDV Co-administered with an Hepatitis A Virus Vaccine
    A.4.1Sponsor's protocol code numberDEN-314
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Vaccines, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTakeda Vaccines, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Pharmaceuticals International AG
    B.5.2Functional name of contact pointAssoc. Dir., Program Physician
    B.5.3 Address:
    B.5.3.1Street AddressThurgauerstrasse 130
    B.5.3.2Town/ cityGlattpark-Opfikon (Zurich)
    B.5.3.3Post code8152
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+410445551389
    B.5.6E-mailAthanasia.Papadimitriou@takeda.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTetravalent Dengue Vaccine Candidate (TDV)
    D.3.2Product code TAK-003
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTDV CHIMERIC DENGUE VIRUS SEROTYPE 1
    D.3.9.2Current sponsor codeTDV-1
    D.3.9.3Other descriptive nameTDV CHIMERIC DENGUE VIRUS SEROTYPE 1
    D.3.9.4EV Substance CodeSUB188351
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/ml plaque forming unit(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number4000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTDV DENGUE VIRUS SEROTYPE 2
    D.3.9.2Current sponsor codeTDV-2
    D.3.9.3Other descriptive nameTDV DENGUE VIRUS SEROTYPE 2
    D.3.9.4EV Substance CodeSUB188352
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/ml plaque forming unit(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number1000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTDV CHIMERIC DENGUE VIRUS SEROTYPE 3
    D.3.9.2Current sponsor codeTDV-3
    D.3.9.3Other descriptive nameTDV CHIMERIC DENGUE VIRUS SEROTYPE 3
    D.3.9.4EV Substance CodeSUB188353
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/ml plaque forming unit(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number20000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTDV CHIMERIC DENGUE VIRUS SEROTYPE 4
    D.3.9.2Current sponsor codeTDV-4
    D.3.9.3Other descriptive nameTDV CHIMERIC DENGUE VIRUS SEROTYPE 4
    D.3.9.4EV Substance CodeSUB188354
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/ml plaque forming unit(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number60000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name HAVRIX
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHepatitis A Vaccine (inactivated, adsorbed)
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHEPATITIS A VIRUS (INACTIVATED ) ADSORBED ON ALUMINIUM HYDROXIDE HYDRATED PRODUCED ON HUMAN DIPLOID (MRC-5) CELLS
    D.3.9.3Other descriptive nameHEPATITIS A VIRUS (INACTIVATED ) ADSORBED ON ALUMINIUM HYDROXIDE HYDRATED PRODUCED ON HUMAN DIPLOID (MRC-5) CELLS
    D.3.9.4EV Substance CodeSUB25294
    D.3.10 Strength
    D.3.10.1Concentration unit ELISA unit/ml enzyme-linked immunosorbent assay unit/millitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1440
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy Volunteers
    "Vaccination against Dengue Fever and co-administration with Hepatitis A vaccine"
    E.1.1.1Medical condition in easily understood language
    Dengue fever is caused by infection with dengue virus, a RNA virus that occurs as 4 recognized serotypes: DENV-1, -2, -3, or -4. These viruses are transmitted from
    human to human by mosquitoes.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10012312
    E.1.2Term Dengue fever virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate NI of the immune response to 1 dose of HAV vaccine in HAV/DENV-naive subjects 1 month following co-administration with 1 dose of TDV (Group 3) compared to 1 dose of HAV vaccine co-administered with placebo (Group 1).
    E.2.2Secondary objectives of the trial
    Immunogenicity
    -To describe the immune response to TDV in HAV/DENV-naive subjects 1 month following a second dose of TDV given 3 months after a first dose of TDV co-administered with HAV
    vaccine (Group 3) or placebo (Group 2).
    - To describe the immune response to TDV in HAV/DENV-naive subjects 1 month following a first dose of TDV co-administered with HAV vaccine (Group 3) or placebo (Group 2).
    - To describe the immune response to the HAV vaccine in HAV/DENV-naive subjects 1 month following 1 dose of HAV vaccine co-administered with TDV (Group 3) or placebo
    (Group 1).

    Safety
    - To assess the safety profile after each vaccine injection in Groups 1, 2 and 3.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject is aged 18 to 60 years, inclusive.
    2. Individuals who are 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 subject 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. Assent is obtained from the subject where required.
    4. Individuals who can comply with trial procedures and are available for the duration of follow-up.
    E.4Principal exclusion criteria
    1. Individuals with an elevated oral temperature (≥38°C or 100.4°F) within 3 days of the intended date of vaccination (consider whether applicable as an exclusion criterion or criterion for delay.
    2. Known hypersensitivity or allergy to any of the vaccine components (including excipients of the investigational vaccines or placebo).
    3. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject’s ability to participate in the trial.
    4. Individuals with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (eg, Guillain-Barré syndrome).
    5. 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 subject due to participation in the trial.
    6. Known or suspected impairment/alteration of immune function, including:
    a. 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).
    b. 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).
    c. Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial.
    d. Receipt of immunostimulants within 60 days prior to Day 1(M0).
    e. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (M0).
    f. Human immunodeficiency virus (HIV) infection or HIV-related disease.
    g. HAV infection.
    h. Hepatitis C virus infection.
    i. Genetic immunodeficiency.
    7. Abnormalities of splenic or thymic function.
    8. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
    9. Individuals with any serious chronic or progressive disease according to judgment of the Investigator (eg, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
    10. Individuals with body mass index (BMI) greater than or equal to 35 kg/m2 (=weight in kg/[height in meters2]).
    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. Individuals who 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. Previous HAV vaccination (in a clinical trial or with an approved product).
    14. Individuals involved in the trial conduct or their first degree relatives.
    15. Individuals with history of substance or alcohol abuse within the past 2 years.
    16. Female subjects who are pregnant or breastfeeding.
    17. 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).
    18. 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 (Day 90 [M3]). In addition, they must be advised not to donate ova during this period.
    19. Any positive or indeterminate pregnancy test.
    20. Previous and planned vaccination (during the trial conduct) against any flaviviruses including dengue, yellow fever (YF), Japanese Encephalitis (JE) viruses or tick-borne encephalitis.
    21. Previous participation in any clinical trial of a dengue or other flavivirus (eg, West Nile [WN] virus) candidate vaccine, except for subjects who received placebo in those trials.
    22. Subjects with a current or previous infection witha flavivirus such as dengue, Zika, YF, JE, WN fever, tick-borne encephalitis or Murray Valley encephalitis and subjects with a history of prolonged (≥1 year) habitation in a dengue endemic area.
    23. Individuals with contraindications, warnings and/or precautions to vaccination with the HAV vaccine as specified within the product information.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects HAV/DENV-naive at Baseline who are seroprotected against HAV at Day 30 (Month 1 [M1]) as measured by enzyme-linked immunosorbent assay (ELISA) (seroprotection rate) in a subset of 120 subjects in each group (immunogenicity subset). Seroprotection is defined as serum anti-HAV antibody levels ≥10 mIU/mL.
    Immunological naivety to HAV/DENV is defined as anti-HAV antibody levels <10 mIU/mL and reciprocal neutralizing titers for all 4 dengue serotypes <10.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 30 (Month 1 [M1])
    E.5.2Secondary end point(s)
    Immunogenicity (immunogenicity subset):
    - Geometric mean titers (GMT) of neutralizing antibodies (microneutralization test [MNT50]) for each of the 4 dengue serotypes at Day 30 (M1) and Day 120 (Month 4 [M4]) in subjects HAV/DENV-naive at Baseline.
    Proportion of subjects HAV/DENV-naive at Baseline who are seropositive for each of the 4 dengue serotypes at Day 30 (M1) and Day 120 (M4) (seropositivity rate). Seropositivity is defined as a reciprocal neutralizing titer ≥10.
    - Geometric mean concentrations (GMC) of anti-HAV antibodies on Day 30 (M1) in subjects HAV/DENV-naive at Baseline.

    Safety (all subjects):
    - Frequency and severity of solicited local (injection site[s]) adverse events (AE) for 7 days (day of vaccination + 6 subsequent days) and solicited systemic AEs for 14 days (day of
    vaccination + 13 subsequent days) after each trial vaccination.
    - Percentage of subjects with any unsolicited AEs for 28 days (day of vaccination + 27 subsequent days) after each trial vaccination.
    - Percentage of subjects with serious adverse events (SAE) throughout the trial.
    - Percentage of subjects with medically attended adverse events (MAAE) throughout the trial.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity:
    Day 30 (M1) and Day 120 (Month 4 [M4])
    Safety:
    Throughout the trial
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Observer blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 900
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state900
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Synexus
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-09
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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