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    Summary
    EudraCT Number:2014-002644-40
    Sponsor's Protocol Code Number:B3451002
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-03-12
    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 ConcernedGermany - PEI
    A.2EudraCT number2014-002644-40
    A.3Full title of the trial
    A PHASE 2b, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
    TO EVALUATE THE SAFETY AND EFFICACY OF STAPHYLOCOCCUS AUREUS 4-
    ANTIGEN VACCINE (SA4Ag) IN ADULTS UNDERGOING ELECTIVE OPEN
    POSTERIOR SPINAL FUSION PROCEDURES WITH MULTILEVEL
    INSTRUMENTATION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Posterior Spinal Fusion Procedure (STRIVE)
    A.4.1Sponsor's protocol code numberB3451002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02388165
    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 SponsorPfizer Inc, 235 East 42nd Street, New York, NY 10017
    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 supportPfizer Inc, 235 East 42nd Street, New York, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1800718 1021
    B.5.5Fax number+1303739 1119
    B.5.6E-mailclinicaltrials.govCallCenter@pfizer.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.3.2Product code PF-06290510
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.3Other descriptive nameCP5-CRM197 Conjugate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.3Other descriptive nameCP8-CRM197 Conjugate
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.3Other descriptive namermClfA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.3Other descriptive namerP305A
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboLyophilisate for solution 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
    Prophylaxis for prevention of Post-operative S aureus infection
    E.1.1.1Medical condition in easily understood language
    Bacterial 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 20.1
    E.1.2Level PT
    E.1.2Classification code 10060945
    E.1.2Term Bacterial infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10004035
    E.1.2Term Bacterial infection due to staphylococcus aureus
    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
    Primary Efficacy Objective
    To assess the efficacy of SA4Ag in the prevention of postoperative S
    aureus BSI and/or deep incisional or organ/space SSI occurring within
    90 days of elective open posterior spinal fusion procedures with
    multilevel instrumentation, in adults aged 18 to <86 years.
    Primary Safety Objective
    To describe the safety and tolerability of a single vaccination of SA4Ag in
    adults aged 18 to <86 years undergoing elective open posterior spinal
    fusion procedures with multilevel instrumentation, by measuring local
    reactions, systemic events, and AEs.
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of SA4Ag in the prevention of postoperative S
    aureus BSI and/or deep incisional or organ/space SSI occurring within
    180 days of elective open posterior spinal fusion procedures with
    multilevel instrumentation, in adults 18 to <86 years of age.
    • To assess the efficacy of SA4Ag in the prevention of postoperative S
    aureus SSI occurring within 90 days of elective open posterior spinal
    fusion procedures with multilevel instrumentation, in adults 18 to <86
    years of age.
    • To assess the efficacy of SA4Ag in the prevention of postoperative S
    aureus SSI occurring within 180 days of elective open posterior spinal
    fusion procedures with multilevel instrumentation, in adults 18 to <86
    years of age.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must personally sign and date the informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
    2. Subject must be aged 18 to <86 years at the time of enrollment.
    3. Subject must be scheduled to undergo an elective open posterior
    spinal fusion procedure with multilevel instrumentation 10 to 60 days
    after study vaccination.
    4. Subject must be available for the entire duration of the study, and willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, including completion of the electronic diary (e-diary) for 10 days after study vaccination. (If surgery occurs on Day 10, then the e-diary does not need to be completed for that day).
    5. Subject must be able to be contacted by telephone during study participation.
    6. Male subjects and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study.
    E.4Principal exclusion criteria
    1. Planned spinal fusion procedure requiring separate operations
    performed on separate days (ie, staged procedure).
    2. Single-level spinal fusions without insertion of multilevel
    instrumentation (ie, surgical implantation of prosthetic material
    involving 2 or more motion segments).
    3. Surgical indication of malignancy, infection, or acute or emergency
    trauma (ie, related to a traumatic incident occurring within 6 months
    prior to study enrollment).
    4. History of major surgery (specifically, an open procedure that enters a
    body cavity, organ, or joint space) within 3 months prior to enrollment,
    or anticipated major surgery other than the index surgical procedure
    between study enrollment and completion of study participation.
    5. History of any spinal surgery performed within 6 months prior to
    study enrollment.
    6. History of any previous spinal surgery resulting in postoperative BSI
    or SSI.
    7. Congenital or acquired immunodeficiency disorder, or rheumatologic
    disorder or other illness requiring chronic treatment with known
    immunosuppressant medications, including monoclonal antibodies,
    within the year prior to enrollment or the use of systemic corticosteroids
    (equivalent of ≥10 mg/day of prednisone) for >14 days within 30 days
    prior to study enrollment.
    8. History of leukemia, lymphoma, or underlying bone marrow disorder
    (eg,
    myelodysplasia, myeloma, myeloproliferative disorder) or history of
    bone marrow transplant.
    9. Malignancy that required treatment with chemotherapy,
    immunotherapy, radiation therapy, or other antineoplastic target
    therapies within 24 months prior to study enrollment.
    10. Any known or suspected malignancy to the spine.
    11. Congenital, functional, or surgical asplenia.
    12. End-stage renal disease (defined as requiring or anticipating
    requirement for hemodialysis, peritoneal dialysis, or renal transplant) or
    nephrotic syndrome.
    13. Any contraindication to vaccination or vaccine components, including
    history of anaphylactic reaction to any vaccine or vaccine-related
    component.
    14. Receipt of blood products or immunoglobulins (including monoclonal
    antibodies) within 6 months prior to study enrollment OR anticipated
    receipt of blood products or immunoglobulins (including monoclonal antibodies) prior to the index hospital admission.
    15. Previous administration of S aureus vaccine or S aureus/Candida
    vaccine.
    16. Antibiotic therapy for microbiologically confirmed ISA disease within
    12 months prior to enrollment.
    17. Participation in other studies involving investigational drug(s)
    (Phases 1-4) within 30 days before the current study begins and/or
    anticipated participation during the study.
    18. Pregnant females, breastfeeding females, and males and females of
    childbearing potential who are unwilling or unable to use a highly
    effective method of contraception, for the duration of the study.
    19. Presence of a colostomy, urostomy, tracheostomy, percutaneous
    gastrostomy tube, indwelling vascular or urinary catheter, central
    nervous system shunt, central nervous system implanted device, or
    spinal cord stimulator; OR anticipated presence of a colostomy,
    urostomy, tracheostomy, percutaneous gastrostomy tube, indwelling
    vascular or urinary catheter, central nervous system shunt, central
    nervous system implanted device, or spinal cord stimulator prior to the
    index hospital admission.
    20. Other severe acute or chronic medical or psychiatric condition
    (including drug and alcohol dependencies) or laboratory abnormality
    that may increase the risk associated with study participation or
    investigational product administration or may interfere with the
    interpretation of study results and, in the judgment of the investigator,
    would make the subject inappropriate for entry into this study.
    21. Subjects who are investigational site staff members directly involved
    in the conduct of the study and their family members, site staff members
    otherwise supervised by the investigator, or subjects who are Pfizer
    employees directly involved in the conduct of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint
    The number of subjects in each vaccine group with postoperative S
    aureus BSI and/or deep incisional or organ/space SSI occurring within
    90 days of elective open posterior spinal fusion procedures with
    multilevel instrumentation, as confirmed by the event adjudication
    committee (EAC).

    Primary Safety Endpoints
    • Number and proportion of subjects in each vaccine group with local reactions (redness, swelling, and pain) occurring within the 10-day period following study vaccination.
    • Number and proportion of subjects in each vaccine group with systemic events (fever, fatigue, headache, vomiting, diarrhea, muscle or joint pain) occurring within the 10-day period following study vaccination.
    • Number and proportion of subjects in each vaccine group with AEs reported during the following time periods:
    - From vaccination until the day of surgery
    - From vaccination until the Day 42 postoperative evaluation
    - From the day of surgery until the Day 42 postoperative evaluation
    - From the Day 42 postoperative evaluation until the day 180 postoperative evaluation (newly diagnosed chronic medical disorders)
    • Number and proportion of subjects in each vaccine group with serious adverse events (SAEs) reported during the following time periods:
    - From vaccination until the Day 180 postoperative evaluation
    - From vaccination until the day of surgery
    - From the day of surgery until the Day 180 postoperative evaluation
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various - see protocol
    E.5.2Secondary end point(s)
    • The number of subjects in each vaccine group with postoperative S
    aureus BSI and/or deep incisional or organ/space SSI occurring within
    180 days of elective open posterior spinal fusion procedures with
    multilevel instrumentation.
    • The number of subjects in each vaccine group with postoperative S
    aureus SSI occurring within 90 days of elective open posterior spinal
    fusion procedures with multilevel instrumentation.
    • The number of subjects in each vaccine group with postoperative S
    aureus SSI occurring within 180 days of elective open posterior spinal
    fusion procedures with multilevel instrumentation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various - see protocol
    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
    Tolerability and 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Austria
    Brazil
    Bulgaria
    Canada
    France
    Germany
    Hungary
    India
    Japan
    Korea, Republic of
    Netherlands
    Romania
    Spain
    Sweden
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days21
    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: 4500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1500
    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 Yes
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 6000
    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 specified
    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 Decision2015-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-07-26
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