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    Summary
    EudraCT Number:2018-003850-25
    Sponsor's Protocol Code Number:PXVX-VC-200-006
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-12-04
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2018-003850-25
    A.3Full title of the trial
    A Phase 4 Study to Assess the Safety and Immunogenicity of VAXCHORA (Cholera Vaccine, Live, Oral) in Children 2 to <18 Years of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial of Vaxchora cholera vaccine in children
    A.4.1Sponsor's protocol code numberPXVX-VC-200-006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03220737
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/286/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPaxVax Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPaxVax Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPaxVax Berna GmbH
    B.5.2Functional name of contact pointDirector Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressOberreidstrasse 68
    B.5.3.2Town/ cityThoerishaus
    B.5.3.3Post codeCH-3174
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number41318885168
    B.5.6E-mailwschlimme@paxvax.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 Yes
    D.2.1.1.1Trade name Vaxchora
    D.2.1.1.2Name of the Marketing Authorisation holderPaxVax Bermuda Limited
    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.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Yes
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of cholera
    E.1.1.1Medical condition in easily understood language
    Prevention of severe diarrhoea caused by cholera bacteria
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10047398
    E.1.2Term Vibrio cholerae gastroenteritis
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008632
    E.1.2Term Cholera due to Vibrio cholerae
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008634
    E.1.2Term Cholera, unspecified
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10008633
    E.1.2Term Cholera due to Vibrio cholerae el tor
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045658
    E.1.2Term Unspecified cholera
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10047397
    E.1.2Term Vibrio cholera gastroenteritis
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10070172
    E.1.2Term Vibrio cholerae test positive
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1) For each of Cohort 1: 12 to <18 years, Cohort 2: 6 to <12 years and Cohort 3: 2 to <6 years
    Primary Immunogenicity Objectives:
    • Demonstrate that the seroconversion rate at Day 11 in pediatric subjects is non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
    • Demonstrate that the seroconversion rate in pediatric subjects is greater than or equal to 70% with 98.3% confidence.
    Primary Safety Objectives:
    Objective:
    • Evaluate the safety and clinical acceptability of VAXCHORA in children.
    • Evaluate the acceptability of VAXCHORA
    • Evaluate the palatability of VAXCHORA
    E.2.2Secondary objectives of the trial
    1) For Cohort 1: 12 to <18 years
    Secondary Immunogenicity Objectives:
    • Seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Days 29, 91 and 181 for all subjects.
    • Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Days 365, 547 and 730 for vaccinees participating in the sub-study.
    Exploratory Immunogenicity Objective:
    • Explore memory B cell response to VAXCHORA vaccination at each time point.

    2) For each of Cohort 2: 6 to <12 years and Cohort 3: 2 to <6 years
    Secondary Immunogenicity Objective
    Evaluate seroconversion rate at Day 29

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The substudy does not have a separate protocol and is included in the main protocol.
    A subset of vaccinees in Cohort 1 will be evaluated for long term seroconversion
    and anti-O1 lipopolysaccharide memory B cell concentration at Days 365, 547 and 730.
    E.3Principal inclusion criteria
    1. Male or female.
    2. Between 2 and <18 years of age on Day 1.
    3. In general good health.
    4. Able and willing to provide informed assent for study participation.
    5. Primary caregiver is able and willing to provide informed consent for study participation.
    6. (for females of childbearing potential) Using an acceptable method of contraception through Day 29
    E.4Principal exclusion criteria
    1. Current acute gastrointestinal illness or loose stools within 3 days of Day 1 visit.
    2. Current acute febrile illness.
    3. History of cholera infection.
    4. History of cholera vaccination.
    5. History of severe allergic reaction (e.g. anaphylaxis) to any ingredient of VAXCHORA.
    6. Congenital or acquired immunodeficiency.
    7. (for females of childbearing potential) Pregnant
    8. Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject.
    9. Any other condition that, in the opinion of the Investigator, will interfere with the conduct of the study or the validity of the data.
    10. Duration of >2 weeks of abnormal stool pattern, defined as <3 stools per week or >2 stools per day in the past 6 months.
    11. Regular use of laxatives in the past 6 months.
    12. History of enterotoxigenic E. coli infection.
    13. Travel to cholera-endemic area in the previous 5 years.
    14. Nursing/breastfeeding.
    15. Received or plans to receive the following from 14 days prior to the study vaccination through 11 days after vaccination:
    Any other licensed vaccines
    Antibiotics or chloroquine or any other investigational agents.
    16. Received or plans to receive any other investigational agent throughout the main study (Day 181).
    E.5 End points
    E.5.1Primary end point(s)
    Primary Immunogenicity endpoint
    • The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer. This proportion of seroconverters is called the seroconversion rate.
    Primary Safety Endpoints
    • Solicited adverse events through Day 8: abdominal pain, headache, lack of appetite, tiredness, diarrhea, nausea, vomiting and fever, by age cohort and overall
    • Unsolicited adverse events through Day 29, by age cohort and overall
    • Serious adverse events through Day 181, by age cohort and overall.
    Acceptability Endpoint
    • The percent of subjects in each age cohort able to complete dosing according to protocol
    Palatability Endpoint
    • Palatability of vaccine assessed by the subject using a 5-point Hedonic scale in Cohorts 1 and 2.
    • Palatability of vaccine assessed by the caregiver using a 5-point Hedonic scale in Cohort 3
    E.5.1.1Timepoint(s) of evaluation of this end point
    Seroconversion rate will be measured at Day 11
    Safety will be assessed by solicited adverse events through Day 8, unsolicicted adverse events through Day 29 and serious adverse events through Day 181
    Acceptability and palatability will be assessed at Day 1 following dosing
    E.5.2Secondary end point(s)
    1) For Cohort 1: 12 to <18 years
    Secondary immunogenicity endpoints
    • Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Days 29, 91 and 181 for all subjects.
    • Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Days 365, 547 and 730 for vaccinees participating in the sub-study
    Exploratory Immunogenicity Endpoint:
    • Associated memory B cell endpoints: Anti–O1 lipopolysaccharide (LPS) memory B cell concentration at Days 1, 91, 181 for the subjects in the active treatment group and the placebo crossover group and Days 365, 547, 730 for the subjects in the active treatment group who participate in the sub-study
    2) For each of Cohort 2: 6 to <12 years and Cohort 3: 2 to <6 years
    Secondary immunogenicity endpoint
    Seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 29 following one dose of VAXCHORA
    E.5.2.1Timepoint(s) of evaluation of this end point
    For Cohort 1: 12 to <18 years
    • Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Days 29, 91 and 181 for all subjects
    • and at Days 365, 547 and 730 for vaccinees participating in the sub-study
    Exploratory Immunogenicity Endpoint:
    • Associated memory B cell endpoints: Anti–O1 lipopolysaccharide (LPS) memory B cell concentration at Days 1, 91, 181 for the subjects in the active treatment group and the placebo crossover group and Days 365, 547, 730 for the subjects in the active treatment group who participate in the sub-study
    2) For each of Cohort 2: 6 to <12 years and Cohort 3: 2 to <6 years
    Seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 29 following one dose of VAXCHORA
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Information not present in EudraCT
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 595
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 420
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 175
    F.1.2Adults (18-64 years) No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 595
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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