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    Summary
    EudraCT Number:2012-000482-21
    Sponsor's Protocol Code Number:B4671001
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-02-10
    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 number2012-000482-21
    A.3Full title of the trial
    A PHASE 3, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE FORMULATED IN MULTIDOSE VIALS GIVEN WITH ROUTINE PEDIATRIC VACCINATIONS IN HEALTHY INFANTS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to test the safety, tolerability and immune response of a vaccine against pneumococcal bacteria, presented in a multidose vial given with other vaccines to healthy infants.
    A.4.1Sponsor's protocol code numberB4671001
    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 Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number001 3037391119
    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 name13-valent pneumococcal conjugate vaccine in a multidose vial
    D.3.2Product code PF-06414256
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM197 CARRIER PROTEIN AND ADSORBED ON ALUMINIUM PHOSPHATE
    D.3.9.4EV Substance CodeSUB129658
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2.2 to 4.4
    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.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 Prevenar 13
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    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.3.2Product code PF-05208760
    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 INNPneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM197 CARRIER PROTEIN AND ADSORBED ON ALUMINIUM PHOSPHATE
    D.3.9.4EV Substance CodeSUB129658
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2.2 to 4.4
    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
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10061353
    E.1.2Term Pneumococcal infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that the immune response induced by 13vPnC with 2-phenoxyethanol in multidose vials (MDVs) is noninferior to the immune response induced by 13vPnC without 2-phenoxyethanol in single-dose syringes (SDSs) as measured by serotype-specific immunoglobulin G (IgG) concentrations 1 month after the infant series.
    E.2.2Secondary objectives of the trial
    To assess the immune response induced by 13vPnC with 2-phenoxyethanol in multidose vials relative to the immune response induced by 13vPnC without 2-phenoxyethanol in single-dose syringes as measured by serotype-specific opsonophagocytic activity (OPA).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject’s parent(s)/legal guardian(s) has been informed of all pertinent aspects of the study. If the subject’s parent(s)/legal guardian(s) is illiterate they must thumbprint the ICD and it must be signed and dated by an impartial witness who was present throughout the entire informed consent process.
    2. Aged 42 to 70 days at time of enrollment.
    3. Available for entire study period.
    4. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
    5. Parent(s)/legal guardian(s) is willing and able to comply with scheduled visits and other study procedures.
    6. Weight of 3.5 kg or greater at the time of enrollment.
    E.4Principal exclusion criteria
    1. Previous vaccination with licensed or investigational pneumococcal vaccine.
    2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
    3. Contraindication to vaccination with pneumococcal conjugate vaccine.
    4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
    5. Known or suspected immune deficiency or suppression.
    6. History of culture-proven invasive disease caused by Streptococcus pneumoniae.
    7. Major known congenital malformation or serious chronic disorder.
    8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma, such as Erb’s palsy.
    9. Receipt of blood products or gamma-globulin since birth and until the blood draw approximately 1 month after the last dose of 13vPnC.
    10. Other severe 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 and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    11. Participation in other studies within 28 days before the current study begins and/or during study participation. Participation in observational studies, and interventional studies such as those where a nasopharyngeal swab or urine sample may be collected, are permitted.
    12. Subjects who are direct descendents (child or grandchild) of investigational site staff members or Pfizer employees directly involved in the conduct of the trial.
    E.5 End points
    E.5.1Primary end point(s)
    - The percentage of subjects achieving a serotype-specific IgG antibody concentration greater than or equal to 0.35 mcg/mL for each of the pneumococcal serotypes measured 1 month after the
    infant series for each vaccine group.
    - The serotype-specific IgG geometric mean concentration (GMC) for each of the pneumococcal serotypes measured 1 month after the infant series for each vaccine group (MDV group or SDS group).
    E.5.1.1Timepoint(s) of evaluation of this end point
    One month after completion of the infant series of injections.
    E.5.2Secondary end point(s)
    - The proportion of subjects in a subset achieving a serotype-specific OPA titer greater than or equal to the lower
    limit of quantitation (LLOQ) for each of the pneumococcal serotypes measured 1 month after the infant series for each vaccine group.
    - The serotype-specific OPA geometric mean titer (GMT) for each of the pneumococcal serotypes 1 month after the infant series for each vaccine group.
    E.5.2.1Timepoint(s) of evaluation of this end point
    One month after completion of the infant series of injections.
    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 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
    Gambia
    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 end of the clinical phase of the study will be the last visit of the last subject. At this time, sites will be closed out, the institutional review board (IRB)/independent ethics committee (IEC) will be informed, and no further Council for International Organizations of Medical Sciences (CIOMS) reports will be sent. For other purposes, the end of the study will be the date the last serology sample is assayed.
    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 months8
    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: 500
    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: 500
    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 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
    Healthy infants ages 42 to 70 days at time of enrollment.
    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 500
    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
    G.4.1Name of Organisation Medical Research Council Unit
    G.4.3.4Network Country Gambia
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Gambia
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