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    Summary
    EudraCT Number:2019-000926-23
    Sponsor's Protocol Code Number:B1851178
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2024-03-07
    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 number2019-000926-23
    A.3Full title of the trial
    A PHASE 3 OPEN-LABEL TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN INFANTS AND YOUNG CHILDREN IN CHINA WHO ARE NAIVE TO PNEUMOCOCCAL VACCINATION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese infants and young children
    A.4.1Sponsor's protocol code numberB1851178
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03574389
    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 SponsorPfizer, 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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address66 Hudson Blvd
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.6E-mailClinicalTrials.gov_Inquiries@Pfizer.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 Prevenar 13/Prevnar 13
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Inc.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 name13-valent pneumococcal conjugate vaccine
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntramuscular 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 Yes
    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 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 nameHaemophilius influenza Type b Vaccine
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntramuscular 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 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
    Pneumococcal Infections
    E.1.1.1Medical condition in easily understood language
    Pneumococcal Infection
    E.1.1.2Therapeutic area Not possible to specify
    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 the immune responses to the 13

    pneumococcal serotypes induced by 13vPnC in

    infants and children 7 months to <6 years of age

    (Cohorts 2, 3, and 4) compared to immune

    responses in infants 6 weeks to 2 months of age

    (Cohort 1).

    To evaluate the safety profile of 13vPnC in infants

    and children 7 months to <6 years of age (Cohorts

    2, 3, and 4) as measured by the incidence rates of

    local reactions, systemic events (including the use

    of antipyretic medication, and adverse events

    (AEs)
    E.2.2Secondary objectives of the trial
    To describe the functional antibody responses as

    measured by opsonophagocytic activity (OPA) to

    the 13 pneumococcal serotypes induced by

    13vPnC in infants and children 7 months to <6

    years of age (Cohorts 2, 3, and 4) compared to

    responses in infants 6 weeks to 2 months of age

    (Cohort 1).

     To describe the immune responses to 13vPnC

    compared to Hib vaccinated controls in Cohorts 2,

    3, and 4.

    To describe the circulating antibody levels to the

    13 pneumococcal serotypes from before

    vaccination through 5 years of age (4 years after

    the last study vaccination) in Cohort 1

     To evaluate the safety profile of 13vPnC as

    measured by the incidence rates of adverse events

    (AEs) in Cohort 1.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Evidence of a personally signed and dated ICD indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study.

    -Aged 6 weeks (42 days) to <6 years at the time of consent.

    -Healthy infants and children as determined by medical history, physical examination, and judgment of the investigator
    E.4Principal exclusion criteria
    -Participation in other studies involving investigational drug(s)/vaccine(s) since birth (Cohort 1 only) or in the 6 months prior to study entry (Cohorts 2, 3, and 4) and/or during study participation.

    -Other acute or chronic medical or psychiatric condition, including recent laboratory abnormality, that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

    -Vaccination with licensed or investigational pneumococcal vaccine.

    -Previous vaccination with licensed or investigational Hib vaccine.
    E.5 End points
    E.5.1Primary end point(s)
    Serotype-specific IgG geometric mean concentrations(GMCs) for each of the pneumococcal serotypes compared to IgG GMCs

    1 month after the last dose of 13vPnC in cohorts 2, 3 and 4 and 1 month after the infant series in cohort 1

    Number of local reactions and systemic events in Cohorts 2, 3 and 4

    7 days after each vaccination

    Number of Adverse Events (AE) from the signing of the informed consent document (ICD) to 1 month after the last vaccination (13vPnC or Hib) in Cohort 2, 3 and 4

    1 month after the last vaccination (13vPnC or Hib) in Cohort 2, 3 and 4



    Number of newly diagnosed chronic medical conditions in Cohort 2, 3 and 4

    1 month after the last study vaccination to 6 months after the last study vaccination

    Number of serious adverse events (SAEs) from the signing of the informed consent document (ICD) to 6 months after the last study vaccination (13vPnC or Hib) in Cohort 2, 3 and 4

    Up to 6 months after the last study vaccination (13vPnC or Hib) in Cohort 2, 3 and 4

    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month after the last dose of 13vPnC in cohorts 2, 3 and 4 and 1 month after the infant series in cohort 1

    7 days after each vaccination

    1 month after the last vaccination (13vPnC or Hib) in Cohort 2, 3 and 4



    1 month after the last study vaccination to 6 months after the last study vaccination

    Up to 6 months after the last study vaccination (13vPnC or Hib) in Cohort 2, 3 and 4

    E.5.2Secondary end point(s)
    Opsonophagocytic activity (OPA) to the vaccine specific serotypes compared to vaccine specific responses OPA

    1 month after the last dose of 13vPnC in cohorts 2,3, 4 and 1 month after infant series in cohort 1

    Serotype specific IgG GMC and OPA GMTs for each of the pneumococcal serotypes compared to IgG and OPA

    1 month after the last vaccination in Cohort 2, 3, 4, whichever comes last, up to 9 months

    Serotype specific IgG GMC for each of the pneumococcal serotypes

    Before vaccination through 5 years of age

    Number of AEs from the signing of the informed consent document (ICD) to 1 month after vaccination 3 in Cohort 1

    Up to 1 month after vaccination 3 in Cohort 1



    Number of newly diagnosed chronic medical conditions from 1 month after vaccination 3 to vaccination 4 in Cohort 1

    1 month after vaccination 3 to vaccination 4 in Cohort 1

    Number of AEs from vaccination 4 to 1 month after vaccination 4 in Cohort 1

    Vaccination 4 to 1 month after vaccination 4 in Cohort 1



    Number of newly diagnosed chronic medical conditions from 1 month after vaccination 4 to 6 months after vaccination 4 in Cohort 1

    1 month after vaccination 4 to 6 months after vaccination 4 in Cohort 1



    Number of serious adverse events (SAEs) from the signing of the informed consent document (ICD) to 6 months after vaccination 4 in Cohort 1

    Up to 6 months after vaccination 4 in Cohort 1

    E.5.2.1Timepoint(s) of evaluation of this end point
    1 month after the last dose of 13vPnC in cohorts 2,3, 4 and 1 month after infant series in cohort 1

    1 month after the last vaccination in Cohort 2, 3, 4, whichever comes last, up to 9 months

    Before vaccination through 5 years of age

    Up to 1 month after vaccination 3 in Cohort 1



    1 month after vaccination 3 to vaccination 4 in Cohort 1

    Vaccination 4 to 1 month after vaccination 4 in Cohort 1



    1 month after vaccination 4 to 6 months after vaccination 4 in Cohort 1



    Up to 6 months after vaccination 4 in Cohort 1

    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    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
    China
    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 years5
    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: 936
    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: 400
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 536
    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 No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infants and young children
    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 936
    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: China
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