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    Summary
    EudraCT Number:2019-003135-36
    Sponsor's Protocol Code Number:CYD67
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-10-31
    Trial results View 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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2019-003135-36
    A.3Full title of the trial
    Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially with Gardasil® in Healthy Subjects Aged 9 to 13 Years in Malaysia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase IIIb, randomized, open-label, multicenter study in 528 subjects aged 9 to 13 years in Malaysia.
    A.4.1Sponsor's protocol code numberCYD67
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02993757
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1161-3376
    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 SponsorSanofi Pasteur SA
    B.1.3.4CountryFrance
    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 supportSanofi Pasteur
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur
    B.5.2Functional name of contact pointTrial Transparency Team
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ city-
    B.5.3.3Post code-
    B.5.3.4CountryFrance
    B.5.6E-mailContact-US@sanofi.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 Yes
    D.2.1.1.1Trade name Dengvaxia
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLive, attenuated, tetravalent dengue virus vaccine
    D.3.4Pharmaceutical form Powder and solvent 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 INNLive, attenuated, tetravalent dengue virus vaccine
    D.3.9.3Other descriptive nameDENGUE TETRAVALENT VACCINE (LIVE, ATTENUATED)
    D.3.9.4EV Substance CodeSUB181517
    D.3.10 Strength
    D.3.10.1Concentration unit log10/ml log10/ml
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number9 to 12
    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.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 GARDASIL
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRecombinant quadrivalent HPV (types 6, 11, 16, 18) vaccine
    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 INNRecombinant quadrivalent HPV vaccine
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB22591
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant quadrivalent HPV vaccine
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB22592
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant quadrivalent HPV vaccine
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB22593
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant quadrivalent HPV vaccine
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB22594
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dengue Fever

    Dengue Hemorrhagic Fever

    Human Papillomavirus Disease
    E.1.1.1Medical condition in easily understood language
    Dengue Fever

    Dengue Hemorrhagic Fever

    Human Papillomavirus Disease
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    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 that the humoral immune response (in terms of geometric mean titers[GMTs]) to Gardasil after concomitant administration is non-inferior to sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Gardasil.

    - To demonstrate that the humoral immune response to the CYD dengue vaccine after concomitant administration is non-inferior to sequential administration with Gardasil measured 28 days after the last dose of the CYD dengue vaccine.
    E.2.2Secondary objectives of the trial
    - To demonstrate that the humoral immune response (in terms of seroconversion) to Gardasil after concomitant administration is non-inferior to sequential administration with the CYD dengue vaccine measured 28 days after the last dose of Gardasil

    - To describe the humoral immune response to Gardasil at baseline and after each dose of Gardasil in each and any group

    - To describe the humoral immune response to the CYD dengue vaccine at baseline and after each dose of the CYD dengue vaccine in each and any group

    - To describe the safety of Gardasil and the CYD dengue vaccine after each and any dose in each group.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subject aged 9 to 13 years (i.e., from the day of the 9th birthday to the day prior to the 14th birthday) on the day of inclusion

    - Informed consent form (ICF) or Assent form (AF) has been signed and dated by the subject (based on local regulations), and/or ICF has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations)

    - Subject (or subject and parent[s] or another legally acceptable representative) is (are) able to attend all scheduled visits and to comply with all trial procedures

    - Subject in good health, based on medical history, and physical examination.
    E.4Principal exclusion criteria
    - Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)

    - Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure

    - Planned receipt of any vaccine in the 4 weeks following any trial vaccination

    - Previous vaccination against dengue disease with the trial vaccine

    - Previous vaccination against HPV disease with either the trial vaccine or another vaccine

    - Receipt of immune globulins, blood or blood-derived products in the past 3 months

    - Known or suspected congenital or acquired immunodeficiency (including HIV infection with impaired immune function); or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

    - History of HPV infection, confirmed either clinically, serologically, or microbiologically as reported by subject or parent(s) or another legally acceptable representative

    - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a
    vaccine containing any of the same substances

    - Thrombocytopenia, contraindicating intramuscular vaccination

    - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination

    - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

    - Current alcohol abuse or drug addiction that, based on investigator's judgment, may interfere with the subject's ability to comply with trial procedures

    - Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion

    - Identified as an Investigator or employee of the Investigator with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study

    - Self-reported Hepatitis B, Hepatitis C infection.
    E.5 End points
    E.5.1Primary end point(s)
    - Antibody levels against each Gardasil human papillomavirus quadrivalent (HPV) antigen (HPV 6, HPV 11, HPV 16, and HPV 18) 28 days after the last dose of Gardasil following either a concomitant or sequential administration with CYD dengue vaccine
    HPV 6, HPV 11, HPV 16, and HPV 18 antibodies will be measured by the competitive Luminex immunoassay.

    - Neutralizing antibody titers against each of the four dengue virus serotype at baseline and 28 days after the last CYD dengue vaccine injection.
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue 50% plaque reduction neutralization test (PRNT50)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Time Frame: Day 28 after the last Gardasil injection

    2. Time Frame: Day 28 after the last CYD dengue vaccine injection
    E.5.2Secondary end point(s)
    - Percentage of participants with seroconversion against each Gardasil HPV antigen (HPV 6, HPV 11, HPV 16, HPV 18) after the last dose of Gardasil
    HPV 6, 11, 16 and 18 antibodies will be measured by the competitive Luminex immunoassay

    - Neutralizing antibody titers against each of the four dengue virus serotype at baseline and 28 days after each CYD dengue vaccine injection
    Neutralizing antibody levels against each dengue virus serotype will be measured using dengue 50% plaque reduction neutralization test (PRNT50)

    - Antibody levels against each Gardasil HPV antigen (HPV 6, HPV 11, HPV 16, and HPV 18) 28 days after each dose of Gardasil following either a concomitant or Sequential administration with CYD dengue vaccine
    HPV 6, HPV 11, HPV 16, and HPV 18 antibodies will be measured by the competitive Luminex immunoassay.

    - Number of participants reporting solicited injection site reactions
    Solicited injection site reactions: Pain, Erythema, and Swelling

    - Number of participants reporting solicited solicited systemic reactions
    Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Asthenia
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Time Frame: Day 28 after the last Gardasil injection

    2. Time Frame: Day 28 after each CYD dengue vaccine injection

    3. Time Frame: Day 28 after each Gardasil injection

    4. Time Frame: Day 0 to Day 7 after each and any injection

    5. Time Frame: Day 0 to Day 14 after each and any injection
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Malaysia
    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.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 528
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 317
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 211
    F.1.2Adults (18-64 years) No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Participants Under the age of 18
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 528
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Malaysia
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