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    Summary
    EudraCT Number:2017-001910-27
    Sponsor's Protocol Code Number:V210-A03
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-07-02
    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 number2017-001910-27
    A.3Full title of the trial
    A Phase 3, Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Passage Extension 34 (PE34) Process Administered Concomitantly with M-M-R™ II
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety of VARIVAX™ Passage Extension 34 (PE34) Process in Children
    A.3.2Name or abbreviated title of the trial where available
    Immunogenicity and Safety of VARIVAX™ Passage Extension 34 (PE34) Process in Children
    A.4.1Sponsor's protocol code numberV210-A03
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03239873
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
    B.5.2Functional name of contact pointHeather L. Platt
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station, New Jersey
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1267-305-1922
    B.5.6E-mailheather.platt@merck.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 nameVaricella Virus Vaccine Live PE34 process
    D.3.2Product code V210
    D.3.4Pharmaceutical form Powder and solvent for suspension 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 INNVaricella Virus Vaccine Live (Oka/Merck)
    D.3.9.2Current sponsor codeV210
    D.3.9.3Other descriptive nameVARICELLA VIRUS OKA/MERCK STRAIN, (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS- Active substance is identical to the one of authorized VARIVAX
    D.3.9.4EV Substance CodeSUB25312
    D.3.10 Strength
    D.3.10.1Concentration unit PFU plaque forming unit
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number1350
    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 RoleComparator
    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 Varivax (MRP)
    D.2.1.1.2Name of the Marketing Authorisation holderMSD Italia S.r.l
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Powder and solvent for suspension 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 INNVaricella Virus Vaccine Live (Oka/Merck)
    D.3.9.2Current sponsor codeV210
    D.3.9.3Other descriptive nameVARICELLA VIRUS OKA/MERCK STRAIN, (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS
    D.3.9.4EV Substance CodeSUB25312
    D.3.10 Strength
    D.3.10.1Concentration unit PFU plaque forming unit
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number1350
    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
    Prevention of varicella in individuals 12 months of age and older
    E.1.1.1Medical condition in easily understood language
    Prevention of varicella in individuals 12 months of age and older
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10069628
    E.1.2Term Varicella immunization
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1) To demonstrate that a single dose of VARIVAX™ PE34 process induces varicella-zoster virus (VZV) antibody responses 6 weeks Postvaccination 1 that are noninferior to those induced by VARIVAX™ 2016 commercial product.
    2) To demonstrate that a single dose of VARIVAX™ PE34 process induces an acceptable VZV antibody response 6 weeks Postvaccination 1.
    E.2.2Secondary objectives of the trial
    1) To assess the safety and tolerability of the first and second doses of VARIVAX™ PE34 process.
    2) To summarize the VZV antibody responses after a single dose of VARIVAX™ PE34 process and after a single dose of VARIVAX™ (2016 commercial product).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be between 12 to 23 months of age upon receipt of the first trial vaccination
    2. Be in good health based on medical history.
    3. Have a negative clinical history for varicella, HZ, measles, mumps, and rubella.
    4. Be able to complete all scheduled visits and comply with the trial procedures.
    5. Have a parent/legally acceptable representative who understands the trial procedures, alternate treatments available, and risks involved with the trial and voluntarily agree to participate in the trial by providing written informed consent.
    E.4Principal exclusion criteria
    1. Received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study
    2. Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity
    3. Received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to receive them during the course of the study
    4. History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of VARIVAX™ or M-M-R II™
    5. Has any blood dyscrasias, leukemia, lymphoma, or other malignant neoplasm affecting the bone marrow or lymphatic systems
    6. Received salicylates within 14 days prior to study vaccination
    7. Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior to study vaccination
    8. Received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to study vaccination
    9. History of seizure disorder, including febrile seizure
    10. Fever illness (>=102.2 °F [39.0 °C] within 72 hours prior to study vaccination
    11. History of thrombocytopenia
    12. Born to a human immunodeficiency virus (HIV)-infected mother
    13. Has a diagnosis of active untreated tuberculosis
    14. Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    •Varicella Zoster Virus (VZV) Antibody Response Rate
    •Varicella Zoster Virus (VZV) Geometric Mean Titer
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks (43 days) after Vaccination 1
    E.5.2Secondary end point(s)
    1. Elevated Temperature
    2. Measles-like, Rubella-like, Varicella-like Rashes, and Mumps-like Symptoms after Vaccination 1
    3. Measles-like, Rubella-like, Varicella-like Rashes, and Mumps-like Symptoms after Vaccination 2
    4. Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness after Vaccination 1
    5. Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness after Vaccination 2
    6. Adverse Events
    7. Serious Adverse Events
    8. Varicella Zoster Virus (VZV) Antibody Seroconversion Rate
    9. Varicella Zoster Virus (VZV) Antibody Geometric Mean Fold Rise from Baseline
    10. Varicella Zoster Virus (VZV) Antibody Geometric Mean Fold Rise from Baseline >=4-fold
    11. Vaccine-related Adverse Events
    12. Vaccine-related Serious Adverse Events
    13. Study Discontinuations due to an Adverse Event
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)
    2. Up to 42 days after Vaccination 1
    3. Up to 42 days after Vaccination 2
    4. Up to 5 days after Vaccination 1
    5. Up to 5 days after Vaccination 2
    6. Up to 42 days after any vaccination
    7. Up to 180 days after vaccination 2 (up to 285 days)
    8. 6 weeks (43 days) after Vaccination 1
    9. Baseline and 6 weeks (43 days) after Vaccination 1
    10. Baseline and 6 weeks (43 days) after Vaccination 1
    11. Up to 42 days after any vaccination
    12. Up to 180 days after vaccination 2 (up to 285 days)
    13. Up to 42 days after any vaccination
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 No
    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 Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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
    United States
    E.8.7Trial has a data monitoring committee No
    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
    The overall trial ends when the last subject completes the last study-related phone-call or visit, withdraws from the trial or is lost to follow-up.
    For purposes of analysis and reporting, the overall study ends when the
    Sponsor receives the last serology assay result.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 600
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 600
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 No
    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 No
    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 600
    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: United States
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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