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    Summary
    EudraCT Number:2010-023384-18
    Sponsor's Protocol Code Number:730901
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-14
    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 ConcernedAustria - BASG
    A.2EudraCT number2010-023384-18
    A.3Full title of the trial
    Randomized, double-blind, phase I/II clinical study to investigate the safety and immunogenicity of a multivalent recombinant OspA Lyme Borreliosis vaccine (mv rOspA LB Vaccine) in healthy subjects aged 18 to 70 years.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase I/II study to investigate the safety and immunogenicity of a Lyme Borreliosis vaccine (mv rOspA LB Vaccine) in healthy subjects aged 18 to 70 years.
    A.3.2Name or abbreviated title of the trial where available
    Phase I/II Lyme Vaccine Study
    A.4.1Sponsor's protocol code number730901
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01504347
    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 SponsorBaxter Innovations GmbH
    B.1.3.4CountryAustria
    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 supportBaxter Innovations GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxter Innovations GmbH
    B.5.2Functional name of contact pointTA Global Operations Mgr
    B.5.3 Address:
    B.5.3.1Street AddressIndustriestrasse 67
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1221
    B.5.3.4CountryAustria
    B.5.4Telephone number+43120100-2471372
    B.5.5Fax number+43120100717
    B.5.6E-mailmichael_krammer@baxter.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 nameMultivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) 30 µg adjuvanted
    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 OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII)
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
    D.3.9.4EV Substance CodeSUB92215
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
    D.3.9.4EV Substance CodeSUB92216
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
    D.3.9.4EV Substance CodeSUB92217
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.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 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 nameMultivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) 60 µg adjuvanted
    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 OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
    D.3.9.4EV Substance CodeSUB92215
    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 OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
    D.3.9.4EV Substance CodeSUB92216
    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 OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
    D.3.9.4EV Substance CodeSUB92217
    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 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.IMP: 3
    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 nameMultivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) 90 µg adjuvanted
    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 OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
    D.3.9.4EV Substance CodeSUB92215
    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 INNRECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
    D.3.9.4EV Substance CodeSUB92216
    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 INNRECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
    D.3.9.4EV Substance CodeSUB92217
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.IMP: 4
    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 nameMultivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) 30 µg non-adjuvanted
    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 OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
    D.3.9.4EV Substance CodeSUB92215
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
    D.3.9.4EV Substance CodeSUB92216
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
    D.3.9.4EV Substance CodeSUB92217
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 5
    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 nameMultivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) 60 µg non-adjuvanted
    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 OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
    D.3.9.4EV Substance CodeSUB92215
    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 OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
    D.3.9.4EV Substance CodeSUB92216
    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 OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
    D.3.9.4EV Substance CodeSUB92217
    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 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.IMP: 6
    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 nameMultivalent Recombinant OspA Lyme Borreliosis Vaccine (mv rOspA LB Vaccine) 90 µg non-adjuvanted
    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 OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 1/2 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPE 1 AND 2 MOLECULES (B. BURGDORFERI S.S. AND B. AFZELII))
    D.3.9.4EV Substance CodeSUB92215
    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 INNRECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 5/3 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 5 AND 3 MOLECULES (B. GARINII))
    D.3.9.4EV Substance CodeSUB92216
    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 INNRECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
    D.3.9.3Other descriptive nameRECOMBINANT OSPA TYPE 6/4 ANTIGEN (CONTAINING PROTECTIVE ELEMENTS FROM SEROTYPES 6 AND 4 MOLECULES (B. GARINII AND B. BAVARIENSIS))
    D.3.9.4EV Substance CodeSUB92217
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    -) To obtain safety and immunogenicity data of different dose levels of a mv rOspA LB Vaccine with and without adjuvant in seronegative healthy volunteers aged 18 to 70 years. The outcome shall provide the basis for dose/formulation selection for Section 2 of the study.
    -) To evaluate the safety and immunogenicity of the optimal dose(s)/formulation of the mv rOspA LB vaccine in a larger population of seronegative and seropositive healthy subjects aged 18 to 70 years.
    E.1.1.1Medical condition in easily understood language
    To obtain safety and immunogenicity data with different doses of an mv rOspA Lyme Borreliosis Vaccine with and without adjuvant, and to evaluate the optimal dose for further investigation.
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10067559
    E.1.2Term Lyme borreliosis
    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 evaluate the safety characteristics and immunogenicity of the mv rOspA LB Vaccine using 6 different formulations (3 dose levels with and without adjuvant) and to identify the optimal dose level(s) and/or formulation of the mv rOspA LB Vaccine in seronegative healthy subjects aged 18 to 70 years.
    -) To evaluate the safety and immunogenicity of the optimal dose(s)/formulation of the mv rOspA LB vaccine in a larger population of healthy seronegative and seropositive subjects aged 18 to 70 years.
    E.2.2Secondary objectives of the trial
    To assess antibody persistence and responses to booster vaccinations with the mv rOspA LB Vaccine.

    Note: The currently applied for Protocol Amendment 6 pertains to Section 3 of the study: In Section 3, approximately 87 subjects who had been randomized to the 9-12 month booster group to receive the 60 µg adjuvanted formulation of the mv rOspA LB Vaccine will be administered a second booster vaccination at 27 months. Based on recent data from Section 2, the 60 µg adjuvanted dose (instead of the 30 µg adjuvanted dose previously applied for with Protocol Amendment 5) has now been selected for this additional booster vaccination in the extension of the study in Section 3.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    * Subject is 18 to 70 years old at the time of screening.
    * Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry;
    * Subject is generally healthy , as determined by the investigator’s clinical judgment through collection of medical history and the performance of a physical examination;
    * Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures;
    * Subject agrees to keep a daily record of symptoms for the duration of the study;
    * If female of childbearing potential, subject presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study.
    Additional inclusion criterion for subjects in Cohort 5 only:
    * Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry
    E.4Principal exclusion criteria
    * Subject has a physician-diagnosed chronic illness related to LB or active LB;
    * Subject has been treated for LB with antibiotics within 3 months of study entry.
    * Subject had a tick bite within 3 weeks prior to screening or first vaccination;
    * Subject has a history of or active infection with Babesia microtii or Anaplasma phagocytosum (ehrlichiosis);
    * Subject currently has or has a history of significant cardiovascular, respiratory (including asthma), metabolic, neurological, hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder ;
    * Subject has clinically significant abnormal laboratory values at screening; NOTE: a 1.5 fold or greater increase over the upper limit of normal (ULN) for ALT and AST and a value of > 1.5 mg/dl for creatinine is considered clinically significant (see Section 12.4.4.2).
    Furthermore, any laboratory parameters included in the FDA toxicity grading scale and graded as moderate or higher are to be considered clinically significant. Clinical significance of all other laboratory parameters will be evaluated by the investigator using his/her clinical expertise and judgment.
    * Subject currently has or has a history of immunodeficiency;
    *Subject tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV); for subjects in Cohort 1 for whom the original exclusion criterion “Subject has a history of testing positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). No confirmatory testing for previous infection with these viruses will be conducted as part of this study” is applicable, testing will be performed at a later time point upon implementation of Amendment 2
    * Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that could be expected to influence immune response. Such treatment includes, but is not limited to: systemic or high dose inhaled (>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment, or other immunosuppressive or cytotoxic drugs;
    * Subject has a history of anaphylaxis or severe allergic reactions;
    *Subject has a rash, dermatologic condition or tattoos which might interfere with injection site reaction rating;
    * Subject has a body mass index > 35.0;
    * Subject has received any blood products or immunoglobulins within 90 days prior to vaccination in this study;
    * Subject has donated blood or plasma within 30 days prior to vaccination in this study;
    * Subject has received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study;
    * Subject has functional or surgical asplenia;
    * Subject has a known or suspected problem with alcohol or drug abuse;
    * Subject has participated in another clinical study involving an investigational product (IP), biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP, biological product or device during the course of this study;
    * Subject is pregnant or lactating at the time of study enrollment;
    * Subject is a member of the team conducting the study or in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study
    Additional exclusion criteria for subjects in Cohorts 1, 2, 3 and 4:
    * Subject is seropositive for Borrelia burgdorferi sensu lato (s.l.) antibodies at study entry. For subjects with a borderline result the test shall be repeated. If the second test confirm a borderline result, the subject shall be excluded.

    Eligibility criteria for the booster vaccination
    E.5 End points
    E.5.1Primary end point(s)
    -) The primary safety endpoint is the frequency and severity of injection site and systemic reactions within 7 days after each vaccination.
    -) The primary immunogenicity endpoint is the antibody response determined 28 days after the third vaccination to each of the 6 rOspA serotypes contained in the vaccine.
    E.5.1.1Timepoint(s) of evaluation of this end point
    -) The primary safety endpoint is the frequency and severity of injection site and systemic reactions within 7 days after each vaccination.
    -) The primary immunogenicity endpoint is the antibody response determined 28 days after the third vaccination to each of the 6 rOspA serotypes contained in the vaccine.
    E.5.2Secondary end point(s)
    Immunogenicity:
    The following endpoints will be determined for each of the 6 rOspA serotypes contained in the vaccine:
    • Antibody response at baseline, 28 days after the first, second and each booster vaccination, 180 and 270 days after the first vaccination,180 days after the first booster vaccination and 180 and 270 days after the second booster vaccination.
    • Fold increase in antibody titer compared to baseline determined 28 days after each vaccination, 180 and 270 days after the first vaccination,180 days after the first booster vaccination and 180 and 270 days after the second booster vaccination.
    • Seroconversion rate (at least 4-fold increase of each rOspA type-specific IgG titer) as compared to baseline determined 28 days after each vaccination, 180 and 270 days after the first vaccination,180 days after the first booster vaccination and 180 and 270 days after the second booster vaccination.
    Safety:
    • Frequency and severity of adverse events (AEs) observed within 28 days after each vaccination and during the entire study period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Ab response at baseline, 28 d after 1st, 2nd & each booster vaccination, 180 & 270 d after 1st vaccination,180 d after 1st booster vaccination & 180 and 270d after the 2nd booster vaccination;
    • Fold increase in Ab titer compared to baseline 28 d after each vaccination, 180 and 270 d after 1st vaccination,180 d after 1st booster vaccination & 180 and 270 d after 2nd booster vaccination;
    • Seroconversion rate (at least 4-fold increase of each rOspA type-specific IgG titer) as compared to baseline determined 28 d after each vaccination, 180 & 270 d after the 1st vaccination, 180 d after the 1st booster vaccination & 180 and 270 d after the 2nd booster vaccination.

    • Frequency and severity of AEs within 28 d after each vaccination ´& during entire study period.
    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 Yes
    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
    Antibody persistance
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    E.8.1.7.1Other trial design description
    In section 3 trial becomes open label
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    same IMP in different dosage with or without adjuvant; in section 3 only 60ug adj will be used
    E.8.2.4Number of treatment arms in the trial6
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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.1.1.1In 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: 649
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state240
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 650
    F.4.2.2In the whole clinical trial 650
    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)
    Only healthy subjects will be included in the trial.
    They will be observed at least 180 days after the last vaccination has taken place. Nothing else is planned beyond this observation period.
    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 Decision2011-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-28
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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