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    Summary
    EudraCT Number:2014-005309-18
    Sponsor's Protocol Code Number:V66_05
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-12-10
    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 number2014-005309-18
    A.3Full title of the trial
    A Ph III, Single Arm, Multi-Center, Open-Label Study to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine Quinvaxem® (DTwP-Hib-HepB Vaccine) when Administered to Indian Infants at 6, 10, and 14 Weeks of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Tolerability of a Fully Liquid Pentavalent Vaccine Quinvaxem® when Administered to Indian Infants at 6, 10, and 14 Weeks of Age
    A.4.1Sponsor's protocol code numberV66_05
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01470287
    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 and Diagnostics
    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 supportNovartis Vaccines and Diagnostics
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Vaccines and Diagnostics
    B.5.2Functional name of contact pointPosting Director
    B.5.3 Address:
    B.5.3.1Street AddressVia Fiorentina 1
    B.5.3.2Town/ citySiena
    B.5.3.3Post code53100
    B.5.3.4CountryItaly
    B.5.6E-mailRegistryContactVaccinesUS@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 Yes
    D.2.1.1.1Trade name Quinvaxem®
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Vaccines and Diagnostics S.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationChile
    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 nameDTwP-HepB-Hib
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPURIFIED DIPHTHERIA TOXOID
    D.3.9.3Other descriptive nameDIPHTHERIA TOXOID
    D.3.9.4EV Substance CodeSUB12489MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPURIFIED TETANUS TOXOID
    D.3.9.3Other descriptive nameTETANUS TOXOID
    D.3.9.4EV Substance CodeSUB12608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBORDETELLA PERTUSSIS (INACTIVATED)
    D.3.9.3Other descriptive nameBORDETELLA PERTUSSIS (INACTIVATED)
    D.3.9.4EV Substance CodeSUB20503
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcapsular oligosaccharide of Haemophilus influenzae type b conjugated to CRM 197
    D.3.9.3Other descriptive nameHAEMOPHILUS TYPE B CONJUGATE VACCINE (DIPHTHERIA CRM197 PROTEIN CONJUGATE)
    D.3.9.4EV Substance CodeSUB25293
    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 INNHEPATITIS B SURFACE ANTIGEN PURIFIED
    D.3.9.3Other descriptive nameHEPATITIS B SURFACE ANTIGEN
    D.3.9.4EV Substance CodeSUB14083MIG
    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 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
    Prophilaxis against diphtheria, tetanus, pertussis, hepatitis B and invasive Haemophilus influenzae type b disease.
    E.1.1.1Medical condition in easily understood language
    Prophilaxis against diphtheria, tetanus, pertussis, hepatitis B and invasive Haemophilus influenzae type b disease.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess one month after third study injection, the percentage of subjects who develop:
    •Seroprotective antibody concentrations to diphtheria, tetanus and HepB
    •Antibody concentrations ≥20 EIU/mL or a 4 fold increase from baseline for B. pertussis,
    •Anti polyribosyl phosphate (PRP) ELISA antibody concentrations > 0.15 ug/mL for Hib (short term protection).
    E.2.2Secondary objectives of the trial
    •To evaluate geometric mean concentration (GMCs) against diphtheria, tetanus, B. pertussis, HepB and Hib antigens one month after third study injection
    •To summarize percentage of subjects with anti-polyribosyl phosphate (PRP) ELISA antibody concentrations 1.0 g/mL (i.e., long term protection) one month after third study injection

    Safety Objectives:
    •To evaluate safety and tolerability of Quinvaxem vaccine administered to infants at days 1, 29 and 57 of the study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male and female subjects ≥ 42 days to ≤ 64 days of age.
    2.Written informed consent obtained from either parents/ legal guardian after the nature of the study has been explained according to local regulatory requirements
    3.Subjects in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator
    4.Available for all scheduled study visits
    E.4Principal exclusion criteria
    1.Subjects whose parents or legal guardians are unwilling or unable to give written informed consent to participate in the study.
    2.History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine.
    3.History of anaphylactic shock, urticaria or other allergic reactions after previous vaccination or known hypersensitivity to any vaccine component.
    4.Known or suspected impairment of immune function, known HIV positivity, receiving immunosuppressive therapy, or having received systemic immunosuppressive therapy within 1 month prior to study entry (note: inhaled and topical steroids are allowed)
    5.Administration of parenteral immunoglobulin preparation and/or blood products since birth
    6.Planned administration of a vaccine not foreseen by the study protocol
    7.Significant acute infection
    8.Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
    9.Subject meeting with a nutritional status grades of I - IV according to the Indian Academy of Pediatrics (IAP) grading of nutritional status.
    10.Participation in another clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    •Percentage of subjects with anti-PRP antibody concentration ≥ 0.15 µg/mL one month after third study injection (i.e., short-term seroprotection rate)
    •Percentage of subjects with anti-HBs antibody concentration ≥ 10 IU/L one month after the third study injection (i.e., seroprotection rate)
    •Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL one month after the third study injection (i.e., seroprotection rate)
    •Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL one month after the third study injection (i.e., seroprotection rate)
    •Percentage of subjects with anti-B. pertussis antibody concentration ≥20 EIU/mL or a 4-fold increase over baseline one month after the third study injection
    E.5.1.1Timepoint(s) of evaluation of this end point
    One month after the third study injection
    E.5.2Secondary end point(s)
    •Percentage of subjects with anti-PRP antibody concentration ≥1.0 µg/mL one month after the third study injection (i.e., long-term seroprotection rate)
    •GMCs for anti-HBs, anti-diphtheria, anti-tetanus, anti-B. pertussis, anti-PRP antibody one month after the third study injection

    Safety:
    •Safety parameters analyzed in this study included: local, systemic solicited AEs, unsolicited AEs, AEs leading to withdrawal, SAEs, medical history and concomitant medications.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Immunogenicity:
    one month after the third study injection

    Safety:
    days 1, 29 and 57 of the study
    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
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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.8.3 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
    India
    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.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    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 Yes
    F.1.1Number of subjects for this age range: 175
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 175
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 175
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: India
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