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    Summary
    EudraCT Number:2014-002978-36
    Sponsor's Protocol Code Number:OVG2014/08
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-12-11
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-002978-36
    A.3Full title of the trial
    Vaccines Against Salmonella Typhi: a phase IIb, single centre, observer-blind, randomised controlled trial to assess the immunogenicity and protective efficacy of Vi conjugated (Vi-TCV) and unconjugated (Vi-PS) polysaccharide vaccines in preventing typhoid infection compared to a control vaccine (meningococcal ACWY), using a human challenge model of typhoid infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vaccines Against Salmonella Typhi (VAST)
    A.3.2Name or abbreviated title of the trial where available
    Vaccines Against Salmonella Typhi (VAST)
    A.4.1Sponsor's protocol code numberOVG2014/08
    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 SponsorThe University of Oxford
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBill and Melinda Gates Foundation
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportAdvanced Immunization Technologies
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oxford
    B.5.2Functional name of contact pointAndrew Pollard
    B.5.3 Address:
    B.5.3.1Street AddressOxford Vaccine Group
    B.5.3.2Town/ cityCCVTM
    B.5.3.3Post codeOX3 7LE
    B.5.4Telephone number01865 234226/226909
    B.5.6E-mailandrew.pollard@paediatrics.ox.ac.uk
    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 Yes
    D.2.1.1.1Trade name Typbar TCV
    D.2.1.1.2Name of the Marketing Authorisation holderBharat Biotech International Limited
    D.2.1.2Country which granted the Marketing AuthorisationIndia
    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 nameTypbar-TCV
    D.3.2Product code Vi-TCV
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    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 INNPurified bulk of typhoid Vi capsular polysaccharide – tetanus toxoid conjugate
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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) No
    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.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 TYPHIM Vi
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameTYPHIM Vi
    D.3.2Product code Vi-PS
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNPurified polysaccharide capsule of Salmonella Typhi (Ty 2 strain)
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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) No
    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.IMP: 3
    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 MENVEO
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Vaccines
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameMENVEO
    D.3.2Product code Meningococcal ACYW-135
    D.3.4Pharmaceutical form Powder 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 INNQuadravalent Meningococcal A, C, Y, W-135 oligosaccharide Diptheria CRM197 conjugate vaccine
    D.3.9.4EV Substance CodeAS3
    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) No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Salmonella enterica serovar Typhi infection
    E.1.1.1Medical condition in easily understood language
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10039446
    E.1.2Term Salmonella typhi infection
    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
    Using an established model of human typhoid infection, whereby healthy adults are deliberately exposed to typhoid-causing bacteria, we will determine how effective a new typhoid vaccine (Vi-TCV) is in preventing infection. The new typhoid vaccine will be compared with a control vaccine (meningococcal ACYW which does not provide protection against typhoid infection). Additionally, the protective effect of the currently used typhoid vaccine (Vi-PS) will also be studied and compared with the control vaccine using this model of typhoid infection.
    E.2.2Secondary objectives of the trial
    1. To compare clinical responses and laboratory features of the response to typhoid infection in participants who have been vaccinated with Vi-TCV, control or Vi-PS vaccines.

    2. To compare the response of the immune system following vaccination with Vi-TCV, control or Vi-PS vaccine by assessing immunological laboratory assays before and after vaccination including antibody, cellular and mucosal responses.

    3. To assess how the immune system is affected after typhoid challenge and to relate these changes to the protective effect of vaccination by comparing immune responses after vaccination with changes after typhoid infection

    4. To assess the persistence of immunological markers following vaccination and typhoid infection

    5. To explore how the genetic response (which protein encoding-genes within the participants DNA are switched on and off) to vaccination in the three vaccine groups varies, and how the genetic response changes after exposure to typhoid challenge.

    6. T
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants must satisfy all of the following criteria to be considered eligible for the study:
    1. Agree to give informed consent for participation in the study.
    2. Aged between 18 and 60 years inclusive at time of enrolment.
    3. In good health as determined by medical history, physical examination and clinical judgment of the study team.
    4. Agree (in the study team's opinion) to comply with all study requirements, including capacity to adhere to good personal hygiene and infection control precautions.
    5. Agree to allow his or her General Practitioner (and/or Consultant if appropriate), to be notified of participation in the study.
    6. Agree to allow study staff to contact his or her General Practitioner to access the participant's vaccination records.
    7. Agree to allow Public Health England to be informed of their participation in the study.
    8. Agree to give his or her close contacts written information informing them of the participant's involvement in the study and offer them voluntary screening for Salmonella Typhi carriage.
    9. Agree to have 24-hour contact with study staff during the four weeks post challenge and are able to ensure that they are contactable by mobile phone for the duration of the challenge period until antibiotic completion.
    10. Agree to allow the study team to hold the name and 24-hour contact number of a close friend, relative or housemate who will be kept informed of the study participant’s whereabouts for the duration of the challenge period (from the time of challenge until completion of antibiotic course). This person will be contacted if study staff are unable to contact the participant.
    11. Have internet access to allow completion of the e-diary and real-time safety monitoring.
    12. Agree to avoid antipyretic/anti-inflammatory treatment from the time of challenge (day 0) until advised by a study doctor or until 14 days after challenge.
    13. Agree to refrain from donating blood for the duration of the study
    14. Agree to provide their National Insurance/Passport number for the purposes of TOPS registration and for payment of reimbursement expenses.


    E.4Principal exclusion criteria
    The participant will not be enrolled if any of the following apply:
    1. History of significant organ/system disease that could interfere with trial conduct or completion. Including, for example, but not restricted to cardiovascular, respiratory, haematological, endocrine, neurological, metabolic, autoimmune, renal, bladder or infectious disease. Biliary tract disease, including biliary colic, asymptomatic gallstones or previous cholecystectomy. Gastro-intestinal disease including requirement for antacids, H2-receptor antagonists, proton pump inhibitors or laxatives. Psychiatric illness requiring hospitalisation or known or suspected drug and/or alcohol misuse (alcohol misuse defined as an intake exceeding 42 units per week).
    2. Have any known or suspected impairment of immune function, alteration of immune function, or prior immune exposure that may alter immune function to typhoid resulting from, for example:
    a. Congenital or acquired immunodeficiency, including IgA deficiency
    b. Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition
    c. Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy
    d. Receipt of immunoglobulin or any blood product transfusion within 3 months of study start.
    e. History of cancer (except squamous cell or basal cell carcinoma of the skin and cervical carcinoma in situ).
    3. Moderate or severe depression or anxiety as classified by the Hospital Anxiety and Depression Score at screening or challenge that is deemed clinically significant by the study doctors .
    4. Weight less than 50kg .
    5. Presence of implants or prosthesis.
    6. Anyone taking long-term medication (e.g. analgesia, anti-inflammatories or antibiotics) that may affect symptom reporting or interpretation of the study results.
    7. Contraindication to ciprofloxacin or macrolide antibiotics.
    8. Female participants who are pregnant, lactating or who are unwilling to ensure that they or their partner use effective contraception one month prior to challenge and continue to do so until two negative stool samples, a minimum of 2 weeks after completion of antibiotic treatment, have been obtained.
    9. Full-time, part-time or voluntary occupations involving clinical or social work with direct contact with young children (defined as those attending pre-school groups or nursery or aged under 2 years), or clinical or social work with direct contact with highly susceptible patients or persons in whom typhoid infection would have particularly serious consequences (unless willing to avoid work until demonstrated not to be infected with S. Typhi in accordance with guidance from Public Health England and willing to allow study staff to inform their employer).
    10. Full time, part time or voluntary occupations involving commercial food handling (involving preparing or serving unwrapped foods not subjected to further heating)
    11. Close household contact with young children (defined as those attending pre-school groups, nursery or those aged less than 2 years )or individual(s) who is (are) immunocompromised.
    12. Scheduled elective surgery or other procedures requiring general anaesthesia during the study period.
    13. Participants who have participated in another research study involving an investigational product that might affect risk of typhoid infection or compromise the integrity of the study within the 30 days prior to enrolment (e.g. significant volumes of blood already taken in previous study) .
    14. Detection of any abnormal results from screening investigations (at the clinical discretion of the study doctors).
    15. Inability to comply with any of the study requirements (at the discretion of the study staff and the participant’s General Practitioner).
    16. Any other social, psychological or health issues which, in the opinion of the study staff, may put the participant or their contacts at risk because of participation in the study, adversely affect the interpretation of the primary endpoint data, impair the participant’s ability to participate in the study.
    17. Having previously received any typhoid vaccine
    18. Having been resident in an enteric fever endemic country for 6 months or more.
    19. Have previously been diagnosed with laboratory-confirmed typhoid or paratyphoid infection or been given a diagnosis compatible with enteric fever.
    20. Have participated in previous typhoid or paratyphoid challenge studies (with ingestion of challenge agent).
    21. Have received vaccination with a vaccine containing tetanus toxoid within the past 12 months.
    22. Have any history of allergy to vaccine components (including tetanus toxoid or Diphtheria CRM protein)
    23. Have a prolonged corrected QT interval (>450 milliseconds) on ECG screening

    E.5 End points
    E.5.1Primary end point(s)
    The proportion of participants developing clinical or microbiologically proven typhoid infection following oral challenge with Salmonella Typhi (Quailes strain) delivered with sodium bicarbonate solution given 28 days after vaccination with Vi conjugated (Vi-TCV) vaccine or Vi unconjugated (Vi-PS) vaccine in comparison to control vaccine (meningococcal ACYW)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Participants will be closely monitored for 14 days after challenge with Salmonella Typhi for a diagnosis of typhoid fever.

    Typhoid fever will be diagnosed if any of the following occur:
    1. A positive blood culture for Salmonella Typhi from 72 hours post-challenge
    2. A positive blood culture for Salmonella Typhi within 72 hours post-challenge, with one or more signs/symptoms of typhoid infection (such as recorded temperature ≥38oC)
    3. Persistent positive blood cultures (two or more blood cultures taken at least 4 hours apart) for Salmonella Typhi within 72 hours post-challenge.
    4. Oral temperature ≥38oC persisting for 12 hours
    E.5.2Secondary end point(s)
    1. Comparison of the clinical course of typhoid infection after challenge between control and Vi-TCV and Vi-PS vaccination groups, in particular:
    a. time to onset of symptoms
    b. duration of illness
    c. symptom severity
    d. time to onset of bacteraemia
    e. time to onset of stool shedding
    f. inflammatory response
    Using clinical reporting, physical examination findings, microbiological assays to detect Salmonella Typhi in blood and stool, and laboratory assays to monitor inflammatory responses


    2. Immunological laboratory assays to assess innate, humoral, cell-mediated and mucosal responses to vaccination at baseline (Day -28) and post-vaccination time points, including:
    a. Salmonella Typhi antigen specific antibodies and serum bactericidal antibody titres
    b. Cell-mediated responses (including antigen specific cell frequencies, description of lymphocyte populations, B cell repertoire)
    c. Cytokine profile

    3. Immunological laboratory assays to assess innate, humoral, cell-mediated and mucosal responses to challenge will be taken at various time points following challenge, these may include:
    a. Cell-mediated responses (including antigen specific cell frequencies, description of lymphocyte populations, B cell repertoire)
    b. Mucosal responses including Salmonella Typhi specific salivary antibodies and faecal coproantibodies
    c. Cytokine profile and kinetics
    d. Salmonella Typhi antigen specific IgA, IgM and IgG antibodies

    4. Immunological laboratory assays to measure anti-Vi GMT and other antibodies targeting Salmonella Typhi specific antigens at baseline, post-vaccination, post-challenge and follow up time points (Day 90, 180, 365)

    5. Laboratory and high-throughput assays to measure gene expression and protein translation at baseline, post-vaccination and post-challenge time points

    6. Exploratory analysis of blood, faeces, saliva and urine samples including use of assays such as PCR and mass-spectrometry-based techniques

    7. Comparison of the typhoid infection recovery between participants randomised to receive either ciprofloxacin or azithromycin antibiotic therapy, in particular:
    a. time to symptom resolution
    b. time to clearance of bacteraemia
    c. time to cessation of stool shedding
    d. antibiotic tolerability
    Using clinical reporting, microbiological assays to detect Salmonella Typhi in blood and stool, and assays to detect antibiotic drug concentrations

    8. Immunological response data post-vaccination (including Salmonella Typhi specific antibody titres, cell-mediated responses) will be combined with vaccine efficacy data following Salmonella Typhi challenge to investigate if particular immunological markers could be used to predict protection from typhoid infection

    9. Clinical observation and participant responses to assess Vi-TCV vaccine tolerability and safety using Vi-PS and control vaccines as comparators.


    E.5.2.1Timepoint(s) of evaluation of this end point
    Participants will be randomised and vaccinated on day -28
    Post-vaccination timepoints for follow up regarding vaccine tolerability and safety, and to obtain samples will occur on day -27,-25,-21 and day -14.

    Salmonella Typhi challenge will occur on day 0 (approximately 28 days post-vaccination).
    Post-challenge, participants will be reviewed daily for symptoms of typhoid fever and sample collection until diagnosed with typhoid or until day 14 post-challenge (if no diagnosis of typhoid fever is made).

    In participants who develop typhoid fever, further visits and samples will be obtained (12, 24, 48, 72 and 96 hours post-diagnosis).

    After the 14 day intensive challenge period, participants will be reviewed for further sample collection at 28, 90, 180 and 365 days post-challenge.
    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 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 No
    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 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 trial3
    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 concerned1
    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 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
    The clinical phase of the study has ended when the last participant completes their last visit. The definition of the end of the study is when the last assay is performed.
    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 months0
    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 months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 99
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state99
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 99
    F.4.2.2In the whole clinical trial 99
    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)
    This is not relevant as the intervention is a single dose of vaccine.
    There will be no treatment or care after subjects have ended their participant in the study.
    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 Decision2015-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-09
    P. End of Trial
    P.End of Trial StatusOngoing
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