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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-004018-15
    Sponsor's Protocol Code Number:V710-003-02
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-03-29
    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
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2007-004018-15
    A.3Full title of the trial
    A Randomized, Multicenter, Double-Blind, Group-Sequential Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Single Dose of Merck 0657nI Staphylococcus aureus Vaccine (V710) in Adult Patients Scheduled for Cardiothoracic Surgery
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in Adult Patients Scheduled for Cardiothoracic Surgery
    A.4.1Sponsor's protocol code numberV710-003-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00518687
    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 organisationMSD Hungary LTD
    B.5.2Functional name of contact pointCsilla Pozsgay MD.
    B.5.3 Address:
    B.5.3.1Street AddressAlkotás u. 50.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1123
    B.5.3.4CountryHungary
    B.5.4Telephone number+361888-5300
    B.5.5Fax number+361888-5377
    B.5.6E-mailcsilla_pozsgay@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 nameStaphylococcus aureus Recombinant Surface Protein
    D.3.2Product code V710
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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 Yes
    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 placeboInjection*
    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
    Prevention of serious Staphylococcus aureus infection (S. aureus bacteremia and/or deep sternal wound infections/mediastinitis)
    E.1.1.1Medical condition in easily understood language
    Staphylococcus aureus infection
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10069778
    E.1.2Term Vancomycin intermediate staphylococcus aureus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 V710 administered prior to cardiothoracic surgery will reduce the proportion of adult patients who acquire S. aureus bacteremia and/or S. aureus deep sternal wound infections through postoperative day 90. (2) To evaluate the safety profile of a single dose of V710 administered to adult patients prior to cardiothoracic surgery.
    E.2.2Secondary objectives of the trial
    (1) To demonstrate that a single dose of V710 administered prior to cardiothoracic surgery will reduce the proportion of adult patients who acquire any invasive S. aureus infection through postoperative day 90. (2) To demonstrate that a single dose of V710 administered prior to cardiothoracic surgery will reduce the proportion of adult patients who acquire any S. aureus surgical-site infection through postoperative day 90.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is 18 years of age or greater.
    2. Patient is scheduled to undergo cardiothoracic surgery involving a full median sternotomy (not including cardiac transplantation surgery) within 14 to 60 days postvaccination.
    3. Patient is able to understand all study procedures and agrees to participate in the study by providing written informed consent.
    4. Patient intends to participate for the entire study duration (i.e., through postoperative Day 90 for the purposes of active efficacy surveillance for all patients; through postoperative Day 360 for long-term safety surveillance for all patients; and through postoperative Day 360 for long-term immunogenicity and nasal colonization surveillance for a subset of patients [N=400]).
    5. Female patients of reproductive potential are required to have a negative urine or serum pregnancy test immediately prior to study vaccination. Female patients of reproductive potential must have been using an acceptable form of birth control for
    two weeks prior to enrollment, and agree to use an acceptable method of birth control for one month postvaccination. Acceptable methods of birth control include use of hormonal contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, tubal ligation, condoms, or abstinence.
    E.4Principal exclusion criteria
    1. Patient developed invasive S. aureus infection (e.g., bacteremia, endocarditis, pneumonia, mediastinitis, osteomyelitis, etc.) in 3 months prior to study entry.
    2. Patient’s underlying condition is sufficiently unstable so that there is a(>50%) possibility that cardiothoracic surgery will be necessary within 10 days following study entry/vaccination.
    3. Patient is planning to undergo cardiothoracic surgery which does not involve a full median sternotomy (i.e., minimally invasive cardiothoracic surgery).
    4. Patient is planning to undergo cardiac transplantation surgery or sternal debridement to remedy an infection resulting from a prior cardiothoracic surgery.
    5. Patient has any type of ventricular-assist device in place at time of study entry.
    6. Patient has a history of anaphylaxis to any of the vaccine components.
    7. Patient has previously received V710 (in either this study or a previous V710 study).
    8. Patient has received any other investigational S. aureus vaccine or any investigational S. aureus antibodies within the 12 months prior to study entry.
    9. Patient has a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours prior to study vaccination.
    10. Patient has received a live virus vaccine within 30 days prior to receipt of the study vaccine or is scheduled to receive any live virus vaccine within 30 days postvaccination.
    11. Patient has received any other licensed vaccine (including inactivated or recombinant vaccines) within 14 days prior to receipt of the study vaccine or is scheduled to receive any other licensed vaccine (including non-live virus vaccines) within 30 days postvaccination. (NOTE: Influenza and pneumococcal vaccines may be administered during the study, but must be given at least 7 days prior to or at least 15 days after study vaccination).
    12. Patient was administered any immunoglobulin within 90 days prior to study vaccination or is scheduled to receive such products at any time through postoperative Day 90.
    13. Patient has received treatment with systemic (intramuscular, oral, or intravenous) corticosteroids (at a prednisone-equivalent dose of ≥20 mg daily), another immunosuppressive medication (e.g., calcineurin inhibitors, mycophenolate, azathioprine), or biological agents (e.g., rituximab) in the 14 days prior to study vaccination, or is anticipated to receive such medications for a chronic medical condition at any time through postoperative Day 90.
    14. Patient has a known or suspected impairment of immunologic function including, but not limited to, the following conditions: autoimmune disease, moderate/severe hepatic insufficiency or cirrhosis, renal failure or insufficiency (on hemodialysis or peritoneal dialysis), immunoglobulin deficiency, or other congenital or acquired immunodeficiency, including HIV/AIDS.
    15. Patient has a condition such as hemophilia, other severe coagulation disorders, or significantly impaired venous access, in which repeated venipuncture or injections pose more than minimal risk.
    16. Patient is currently pregnant or breastfeeding, or planning to conceive at any time through postoperative Day 90.
    17. Patient has a medical condition in which the expected survival is less than 90 days.
    18. Patient has current evidence or a recent history (within the five years prior to study entry) of intravenous drug abuse.
    19. Patient has participated in another clinical trial in the 4 weeks prior to study entry, or plans to participate in a treatment-based trial or another trial in which an invasive procedure is to be performed, at any time through postoperative Day 90. (NOTE: Participation in a non-interventional surveillance study is acceptable at anytime during the course of this trial).
    20. Patient has a history of any condition that, in the opinion of the investigator, may pose an additional risk to the patient or confound the results of this study.
    E.5 End points
    E.5.1Primary end point(s)
    S. aureus Bacteremia and/or S. aureus deep sternal wound infection (DSWI), including mediastinitis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Date of cardiothoracic surgery through Postoperative Day 90.
    E.5.2Secondary end point(s)
    Any invasive S. aureus infection; Any S. aureus surgical-site infection.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Date of cardiothoracic surgery through Postoperative Day 90.
    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 Yes
    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; Health care resource utilization.
    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) Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    In-house 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 trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Belgium
    Brazil
    Canada
    Chile
    Colombia
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Guatemala
    Hungary
    Ireland
    Japan
    Korea, Democratic People's Republic of
    Malaysia
    Mexico
    New Zealand
    Norway
    Peru
    Poland
    Russian Federation
    Singapore
    Spain
    Sweden
    Taiwan
    United Kingdom
    United States
    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
    Accrual of the required number of primary endpoints at one of the interim or final analyses, and confirmation by an independent Data & Safety Monitoring Board (DSMB) that the prespecified futility or success boundaries have been met.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15000
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    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.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7500
    F.4.2.2In the whole clinical trial 15000
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-08-18
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