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    Summary
    EudraCT Number:2017-001819-36
    Sponsor's Protocol Code Number:Sci-B-Vac–001
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-12-04
    Trial 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 ConcernedFinland - Fimea
    A.2EudraCT number2017-001819-36
    A.3Full title of the trial
    A Phase 3 Double-Blind Randomized Controlled Trial to Compare the Immunogenicity and Safety of a Three-dose Regimen of Sci-B-Vac™ to a Three-dose Regimen of Engerix-B® in Adults (PROTECT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to compare the immune response and safety of 3 doses of Sci-B-Vac™ compared to 3 doses of Engerix-B® in Adults
    A.3.2Name or abbreviated title of the trial where available
    PROTECT
    A.4.1Sponsor's protocol code numberSci-B-Vac–001
    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 SponsorVBI Vaccines Inc.
    B.1.3.4CountryCanada
    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 supportVBI Vaccines Inc
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVBI Vaccines Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address310 Hunt Club Road East
    B.5.3.2Town/ cityOttawa, ON
    B.5.3.3Post codeK1V 1C1
    B.5.3.4CountryCanada
    B.5.4Telephone number+1613749-4200 151
    B.5.6E-mailSciBVacinfo@vbivaccines.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 nameSci-B-Vac™
    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 INNHepatitis B surface antigen
    D.3.9.2Current sponsor codeSci-B-Vac
    D.3.9.3Other descriptive nameHEPATITIS B SURFACE ANTIGENS RECOMBINANT (S, PRE-S1, PRE-S2)
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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 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 Engerix-B™
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline, Research Triangle Park, NC 27709, USA
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameEngerix-B™
    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 INNHepatitis B surface antigen
    D.3.9.3Other descriptive nameHEPATITIS B SURFACE ANTIGEN (RDNA)
    D.3.9.4EV Substance CodeSUB20082
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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.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
    Hepatitis B vaccination in healthy adults
    E.1.1.1Medical condition in easily understood language
    Hepatitis B vaccination in healthy adults
    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 10054181
    E.1.2Term Hepatitis B 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
    To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac™ is non-inferior to the SPR 4 weeks after completion of the three-dose regimen of Engerix-B® in adults ≥18 years of old i.e. the lower bound of the 95% two-sided confidence interval (CI) of the difference between the SPR in the Sci-B-Vac™ arm minus the SPR in the Engerix-B® arm, achieved 4 weeks after receiving the third vaccination, will be > - 5%.

    and

    To demonstrate that the SPR 4 weeks after completion of the three-dose regimen of Sci-B-Vac™ is superior to the SPR 4 weeks after completion of the three-dose regimen of Engerix-B® in older adults ≥ 45 years old i.e. the lower bound of the 95% two-sided CI of the difference between the SPR in the Sci-B-Vac™ arm minus the SPR in the Engerix-B® arm, achieved 4 weeks after receiving the third vaccination, will be > 5%.
    E.2.2Secondary objectives of the trial
    To determine whether the SPR after receiving 2 vaccinations of Sci-B-Vac™, evaluated at 4 weeks and 20 weeks after receiving the second vaccination (just prior to receiving the third vaccination), is non-inferior to the SPR 4 weeks after receiving the third vaccination with Engerix-B®

    To compare the safety and reactogenicity of Sci-B-Vac™ and Engerix-B®.

    Please see protocol for Exploratory objectives
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There are two sub studies a Clinical Laboratory sub study and a Cell mediated immunity direct against HBs described below.

    Clinical Laboratory sub-study.

    At select study sites, clinical laboratory parameters (hematology, biochemistry) will be assessed one week after each vaccination with either Sci-B-Vac or Engerix-B® and compared to baseline (pre-vaccination) values, as part of a clinical laboratory sub-study. All subjects enrolled at these select sites will be required to come for three additional visits and to provide four additional blood samples, beyond those required for the main study. The clinical laboratory sub-study will include at least 10% of all subjects enrolled to the entire trial.

    Blood samples for the clinical laboratory sub-study will be collected at baseline (Day 0, Visit 1) prior to receiving any study vaccine, and at each of the three additional visits (additional visits A1, A2 and A3 in the Protocol: Appendix 2 Schedule of Events), to be scheduled 1 week after each vaccination with Sci-B-Vac™or EngerixB® on Study Day 7 (-3/+7 days), Study Day 35 (-3/+7 days) and Study Day 175 (-3/+7 days), respectively.

    The following clinical laboratory parameters will be evaluated:

    Hematology
    o White blood cell count with differential
    o Red blood cell count
    o Hematocrit (HCT)
    o Mean cell hemoglobin (MCH
    o Mean cell hemoglobin concentration (MCHC)
    o Mean corpuscular volume (MCV)
    o Hemoglobin
    o Platelet count

    Biochemistry:
    o Blood urea nitrogen (BUN), serum creatinine.
    o Alkaline phosphatase (AP), alanine transaminase (ALT), aspartate transaminase (AST),
    total and conjugated bilirubin, gamma-glutamyl-transferase (GGT)

    Safety laboratory evaluations may be repeated if indicated (e.g. follow-up of a clinically significant
    laboratory abnormality (from baseline assessment))

    Optional sub study of cell-mediated immunity directed against HBs

    Cell-mediated immunity directed against HBs and related mechanistic studies will also be studied on a small subset of subjects (~50-75 subjects/treatment arm), recruited from among the subjects participating in the clinical laboratory sub-study. Participation in the sub-study of cell-mediated immunity is optional, and will require a separate consent.

    Subjects who agree to participate in the sub-study of cell-mediated immunity will be asked to provide 4 additional blood samples, beyond those required for the clinical laboratory sub-study, at V1 (Study Day 0) prior to vaccination and at each of three additional visits (A1, A2, A3) 1 week after each vaccination with either Sci-B-Vac™ or Engerix-B® (Study Days 7, 35, 175).

    Lack of participation in the optional sub-study of cell-mediated immunity will not preclude participation the clinical laboratory sub-study or the main study
    E.3Principal inclusion criteria
    Subjects must meet all the following criteria to be eligible:
    1. Any gender.
    2. Age ≥ 18 years.
    3. In stable health as determined by a physical examination and laboratory tests values. Common chronic conditions such as, but not limited to, type 2 diabetes, high blood pressure, COPD, asthma will be accepted if the condition is well controlled, as determined by the investigator, and not meeting the exclusion criteria. For subjects > 65 years old, Frailty Index ≤3 17(see Appendix 1 of the protocol).
    4. If female:
    either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy),
    OR
    is of childbearing potential and must agree to use an adequate birth control method during the screening period and until the end of her participation in the study (effective birth control includes: 1) hormonal (implant, oral, vaginal, transdermal) contraceptives; 2) diaphragm with spermicide, condom (with or without spermicide); 3) intra-uterine devices; and 4) vasectomy of male partner; 5) abstinence from penile-vaginal intercourse (if the preferred and usual lifestyle of the subject)).
    5. Able and willing to give consent.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria will be excluded:

    1.Previous vaccination with any HBV vaccine (licensed or experimental).
    2.Treatment by immunosuppressant within 30 days of enrollment including but not limited to corticosteroids at a dose that is higher than an oral or injected physiological dose, or a prednisolone-equivalent dose >20 mg /day (Inhaled and topical steroids are allowed.
    3.Known history of immunological function impairment, including but not limited to:
    a) autoimmune diseases (e.g., multiple sclerosis, type 1 diabetes, myasthenia gravis, Crohn disease and other inflammatory bowel diseases, celiac disease, systemic lupus erythematosus, scleroderma, including diffuse systemic form and CREST syndrome, systemic sclerosis, dermatomyositis polymyositis, rheumatoid arthritis, juvenile idiopathic arthritis, autoimmune thyroiditis -including Hashimoto thyroiditis, Grave's or Basedow’s disease, immune thrombocytopenic purpura, autoimmune hemolytic anemia, autoimmune hepatitis, psoriasis, vitiligo, vasculitis, Guillain-Barré syndrome, Addison’s disease, Bell’s palsy and alopecia areata);
    OR
    b)secondary immunodeficiency disorders (e.g. resulting from HIV/AIDS (Acquired Immunodeficiency Syndrome caused by Human Immunodeficiency Virus infection), solid organ transplant, splenectomy);
    OR
    c) primary immunodeficiency disorders (e.g. common variable immune deficiency (CVID), Defective phagocytic cell function and neutropenia syndromes, complement deficiency).
    4.Pregnancy or breastfeeding.
    5.Immunization with attenuated vaccines (e.g. MMR) within 4 weeks prior to enrollment.
    6.Immunization with inactivated vaccines (e.g. influenza) within 2 week prior to enrollment.
    7.Has received blood products or immunoglobulin within 90 days of enrollment or likely to require blood products during the study period.
    8.Subject in another clinical trial with an investigational drug or a biologic within 30 days of enrollment.
    9.Has received granulocyte-macrophage colony stimulating factor (G/GM-CSF) or erythropoietin (EPO) within 30 days of enrollment or likely to require GM-CSF/erythropoietin during the study period.
    10.Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease. Subject with a history of low risk basal cell carcinoma will be accepted (low risk being defined by the following: 1) location on the trunk of the body, arms, legs, cheeks, forehead, temples, scalp, neck or chin and 2) less than 2 cm, and 3) nodular or superficial, and 4) primary cancer that has not come back after treatment and 5) edge of the cancerous area is clear and smooth and 6) not located in or around nerves).
    11.Any skin abnormality or tattoo that would limit post-vaccination injection site assessment.
    12.History of allergic reactions or anaphylactic reaction to any vaccine component (Engerix-B® or Sci-B-Vac™).
    13.Unwilling, or unable in the opinion of the investigator, to comply with study requirements, including the use of an adequate birth control method.
    14.Immediate family members of study center staff (parents, sibling, children).
    15.Current or past hepatitis B infection or prior vaccination as evidenced by HBV markers (anti-HBc, anti-HBs, HBsAg) at screening.
    16.Known hepatitis C infection or positive Hepatitis C serology at screening, unless treated and cured (defined as documented sustained virologic response (SVR) or negative viral load ≥ 12 weeks after cessation of antiviral therapy).
    17.Known human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
    18.Renal impairment with Glomerular Filtration Rate (GFR) ≤60 mL/min/1.73 m2 at screening.
    19.Uncontrolled diabetes mellitus (defined as HbA1C >8.5%).
    20.Uncontrolled hypertension (defined as an average SBP ≥150 mmHg or an average DBP ≥95 mmHg based on the last three measurements, in people diagnosed and treated for hypertension).
    21.Any laboratory test abnormality that would be considered of Grade 1 severity or above as per Appendix 4 of the protocol and is considered as clinically significant by the investigator. Grade 3 severity or above is exclusionary, regardless of clinical assessment.
    22.Diagnosis of advanced stage heart failure (New York Heart Association (NYHA) class III or IV – see Appendix 5 of the protocol) or Unstable Angina
    E.5 End points
    E.5.1Primary end point(s)
    Seroprotection rate 4 weeks after receiving third vaccination with either Sci-B-Vac™ or Engerix-B®, on Study Day 196. Seroprotection is defined as anti-HBs levels ≥ 10 mIU/mL in serum. Seroprotection rate is the percentage (%) of subjects achieving seroprotection. A validated quantitative antibody test will be used to measure anti-HBs levels in serum.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study Day 196 (4 weeks post third vaccination )
    E.5.2Secondary end point(s)
    SPR on Study Days, 56 and 168, 4 weeks and 20 weeks after receiving the second Sci-BVac™ vaccination (just prior to receiving the third vaccination), and the SPR on Study Day 196, 4 weeks after receiving the third Engerix-B® vaccination.

    Number (%) of subjects-reported, solicited (on the day of vaccination and during the next 6 days), unsolicited AE (on the day of vaccination and during the next 27 days), and number of Serious SAEs, medically significant events (condition prompting emergency room visit, physician visit not related to a common disease/not a routine visit or an SAE not related to a common disease) or new onset of chronic illness through Study Day 336.

    Adverse events will be classified by Medical Dictionary for Regulatory Activities (MedDRA) system organ class and preferred term, severity, seriousness, investigator and Sponsor causality assessment, and time since vaccination.

    Number (%) of subjects with abnormal vital signs, and/or physical examination findings compared to baseline.

    Please see the protocol for the Exploratory End Points

    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    Belgium
    Canada
    Finland
    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
    Last subject Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days8
    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: 938
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 626
    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 state850
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 904
    F.4.2.2In the whole clinical trial 1564
    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)
    After the database has been locked individual serology results will be communicated to the study sites and subjects will be informed of their results by the study site staff. Study subjects that are found not to be seroprotected (anti-HBs levels < 10mIU/mL in serum) after completing the three-dose regimen of the study vaccine will be offered re-immunization with Engerix-B® according to local guidelines. Engerix-B® will be supplied by the study sponsor.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-08
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