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    Summary
    EudraCT Number:2011-001448-31
    Sponsor's Protocol Code Number:H01_04E1TP
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-07-20
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-001448-31
    A.3Full title of the trial
    A Phase 2, open-label, single-center, extension study to evaluate the booster response induced by Vi-CRM197 after priming with either Vi-CRM197 or Typherix administered in adult subjects in H01_04TP study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, open-label, single-center, extension study to evaluate the response induced by vaccination with Vi-CRM197 1 year after initial vaccination with either Vi-CRM197 or Typherix, which was administered in adult subjects in H01_04TP study
    A.4.1Sponsor's protocol code numberH01_04E1TP
    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 SponsorNovartis Vaccines Institute for Global Health (NVGH)
    B.1.3.4CountryItaly
    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 supportSclavo Vaccines Association with grants received from Regione Toscana and Fondazione Monte Dei Paschi di Siena
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Vaccines Institute for Global Health (NVGH)
    B.5.2Functional name of contact pointCD&RA
    B.5.3 Address:
    B.5.3.1Street AddressVia Fiorentina 1
    B.5.3.2Town/ citySiena
    B.5.3.3Post code53100
    B.5.3.4CountryIsrael
    B.5.4Telephone number00390577243496
    B.5.5Fax number00390577539114
    B.5.6E-mailaudino.podda@novartis.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 nameNVGH Vi-CRM197 conjugate vaccine
    D.3.2Product code Vi-CRM197
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeVi-CRM conjugate
    D.3.9.3Other descriptive nameVi-CRM197 conjugate
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prophylaxis for Salmonella enterica serovar Typhi (S. Typhi) disease
    E.1.1.1Medical condition in easily understood language
    vaccination to protect against typhoid fever
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10039446
    E.1.2Term Salmonella typhi 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
    Safety Objectives:
    To evaluate the safety profile of the NVGH Vi-CRM197 vaccine by measuring rates of local and systemic reactions occurring during 7 days post vaccination and all adverse events occurring for the entire study duration (28 days) in all groups.

    Immunogenicity Objectives:
    - To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 3, 7 and 28 after vaccination in healthy adults who previously received one dose of either NVGH Vi-CRM197 5.0 µg or the licensed Vi polysaccharide vaccine (Vi-PS) and in healthy adults not previously vaccinated with a typhoid vaccine.
    - To evaluate the persistence of the anti-Vi antibody response 12 months after vaccination with one dose of either the NVGH Vi-CRM197 or the licensed Vi-PS in the H01_04TP study.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All Subjects:
    1. Males and females of age ≥18 to ≤42 years.
    2. Individuals, who, after the nature of the study have been explained to them, have given written consent according to local regulatory requirements.
    3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
    4. If women, use of birth control one month before study start, a negative pregnancy test and willingness to use birth control measures for the entire study duration.

    H01_04TP subjects only:
    5. Individuals who previously participated in the H01_04TP study and were vaccinated with either NVGH Vi-CRM197 (5µg) or with the licensed Vi-PS.
    6. Individuals who have received no Vi vaccination subsequent to the one received in the H01_04TP study.
    E.4Principal exclusion criteria
    All subjects:
    1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
    2. Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
    3. Individuals who are not able to understand and to follow all required study procedures for the whole period of the study.
    4. Individuals with history of any illness that, in the opinion of the investigator, pose additional risk to the subjects due to participation in the study.
    5. Individuals with known or suspected HIV infection or HIV related disease, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 30 days, or were in chemotherapy treatment within the past 6 months.
    6. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
    7. Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
    8. Individuals who have any malignancy or lymphoproliferative disorder.
    9. Individuals with history of allergy to vaccine components.
    10. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
    11. Individuals who received any vaccines within 4 weeks prior to enrolment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccine
    12. Individuals who have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks.
    13. Individuals who are part of study personnel or close family members to the personnel conducting this study.
    14. Individuals with body temperature > 38.0 degrees Celsius within 3 days of intended study immunization.
    15. BMI > 35 kg/m2.
    16. Individuals with history of substance or alcohol abuse within the past 2 years.
    17. Women who are pregnant or breast-feeding or of childbearing age who have not used any birth control measure one month prior to study start or do not plan to use acceptable birth control measures, for the duration of the study.
    18. Females with history of stillbirth, neonatal loss, or previous infant with anomaly.
    19. Individuals who have a previously ascertained or suspected disease caused by S. Typhi.
    20. Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. Typhi.
    21. Any condition which, in the opinion of the investigator may interfere with the evaluation of the study objectives.

    Naïve subjects only:
    22. Individuals who have previously received any vaccine against typhoid fever (either oral live attenuated or injectable vaccines)
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity Endpoints
    - Geometric mean concentrations (GMCs), as determined by ELISA, and geometric mean ratios (GMRs) between post- and pre-vaccination samples.
    - Seroconversion rate defined as percentage of subjects achieving at least a four-fold rise in ELISA antibody concentration in the post-vaccination blood samples.

    Safety Endpoints
    - Numbers and percentage of subjects with solicited local and systemic adverse reactions as well as numbers and percentage of subjects with reported unsolicited adverse events (AEs) and serious adverse events (SAEs).
    Solicited local reactions include erythema, induration and pain at injection site; solicited systemic reactions include headache, arthralgia, chills, fatigue, malaise, myalgia, and fever (defined as body temperature ≥38.0°C)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Immunogenicity Endpoints
    - GMCs: pre- (day 1) and post-vaccination (days 3, 7, 28)
    - GMRs: between post- and pre-vaccination samples
    - Seroconversion rate:post-vaccination (days 3, 7, 28)

    Safety Endpoints
    - days 1 to 7
    - AEs throughout the study duration (28 days)
    E.5.2Secondary end point(s)
    none
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity and kinetics of anti-Vi antibody response
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years0
    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.1.1.1In 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: 60
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations 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 state60
    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
    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 Decision2011-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-12-13
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