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    Summary
    EudraCT Number:2019-003308-11
    Sponsor's Protocol Code Number:B7471014
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2022-09-07
    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 number2019-003308-11
    A.3Full title of the trial
    A PHASE 3, SINGLE-ARM TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHILDREN 15 MONTHS THROUGH 17 YEARS OF AGE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Immunogenicity Study of 20vPnC in Healthy Children 15
    Months Through 17 Years of Age
    A.4.1Sponsor's protocol code numberB7471014
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04642079
    A.5.4Other Identifiers
    Name:US INDNumber:017980
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/239/2022
    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 pointClinicalTrials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number18007181021
    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 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 nameApexxnar
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    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 Disease
    E.1.1.1Medical condition in easily understood language
    Prevention of disease caused by a type of bacteria called Streptococcus pneumoniae (pneumococcal 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 describe the safety and immunogenicity profile of 20vPnC
    E.2.2Secondary objectives of the trial
    To further describe the immune responses to 20vPnC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female children ≥15 months to <18 years of age at the time of consent.
    - Healthy children determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
    - For children <5 years of age, written documentation of receipt of at least 3 doses of 13vPnC. The last dose of 13vPnC must have been administered >2 months before enrolment into the study
    E.4Principal exclusion criteria
    - History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
    - Major known congenital malformation or serious chronic disorder
    - Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may
    interfere with the interpretation of study results
    - Previous vaccination with any investigational pneumococcal vaccine or with PPSV23, or planned receipt through study participation
    - Cohorts 3 and 4: Pregnant or breastfeeding female participants
    E.5 End points
    E.5.1Primary end point(s)
    - The percentage of participants reporting prompted local reactions within 7 days after vaccination
    - The percentage of participants reporting prompted systemic events within 7 days after vaccination
    - The percentage of participants reporting Adverse Events (AEs) up to 1 month after vaccination
    - The percentage of participants reporting Serious Adverse Events (SAEs) up to 6 months after vaccination
    - The percentage of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) up to 6 months after vaccination
    - Immunoglobulin G (IgG) Geometric Mean Fold Rises (GMFRs) for the 7 additional serotypes 1 month after vaccination
    - Opsonophagocytic activity (OPA) GMFRs for the 7 additional serotypes 1 month after vaccination
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Day 7
    - Day 7
    - 1 month after vaccination
    - 6 months after vaccination
    - 6 months after vaccination
    - 1 month after vaccination
    - 1 month after vaccination
    E.5.2Secondary end point(s)
    - Percentage of participants with predefined serotype-specific IgG concentrations for the 7 additional serotypes at 1 month after vaccination in Cohort 1 only
    - Percentage of participants with ≥4-fold rise in serotype-specific OPA titers for the 7 additional serotypes from before to 1 month after vaccination in Cohorts 2, 3, and 4 only
    - IgG Geometric Mean Concentrations (GMCs) for the 20vPnC serotypes before and 1 month after vaccination
    - IgG GMFRs for the 13vPnC serotypes from before to 1 month after vaccination
    - IgG GMFRs for the 20vPnC serotypes from before to 1 month after vaccination
    - OPA Geometric Mean Titers (GMTs) for the 20vPnC serotypes before and 1 month after vaccination
    - OPA GMFRs for the 20vPnC serotypes from before to 1 month after vaccination
    - OPA GMFRs for the 13vPnC serotypes from before to 1 month after vaccination
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 1 month after vaccination
    - from before to 1 month after vaccination
    - before and 1 month after vaccination
    - before to 1 month after vaccination
    - before to 1 month after vaccination
    - before and 1 month after vaccination
    - before to 1 month after vaccination
    - before to 1 month after vaccination
    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 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.8.2.4Number of treatment arms in the trial1
    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 months2
    E.8.9.2In all countries concerned by the trial days2
    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: 800
    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: 200
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 450
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 150
    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 Information not present in EudraCT
    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 800
    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: United States
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