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    Summary
    EudraCT Number:2014-004177-16
    Sponsor's Protocol Code Number:B1841007
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-04-09
    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 number2014-004177-16
    A.3Full title of the trial
    A Phase 4, Randomized, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of DTaP Vaccine in Healthy Infants Given With a 7-valent Pneumococcal Conjugate Vaccine in Japan.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.
    A.4.1Sponsor's protocol code numberB1841007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01250756
    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 Japan, Inc.
    B.1.3.4CountryJapan
    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 Japan, Inc.
    B.4.2CountryJapan
    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 code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 800 7181021
    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
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Japan Inc.
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 Suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE CONJUGATE SEROTYPE 4
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197
    D.3.9.4EV Substance CodeSUB25336
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE CONJUGATE SEROTYPE 6B
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197
    D.3.9.4EV Substance CodeSUB25356
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE CONJUGATE SEROTYPE 9V
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197
    D.3.9.4EV Substance CodeSUB25343
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE CONJUGATE SEROTYPE 14
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197
    D.3.9.4EV Substance CodeSUB25341
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL OLIGOSACCHARIDE SEROTYPE 18C
    D.3.9.3Other descriptive namePNEUMOCOCCAL OLIGOSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197
    D.3.9.4EV Substance CodeSUB25338
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE CONJUGATE SEROTYPE 19F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197
    D.3.9.4EV Substance CodeSUB25337
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE CONJUGATE SEROTYPE 23F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197
    D.3.9.4EV Substance CodeSUB25368
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.2
    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 Yes
    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 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 DPT “KAKETSUKEN”
    D.2.1.1.2Name of the Marketing Authorisation holderKAKETSUKEN
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN DIPHTHERIA TOXOID
    D.3.9.3Other descriptive nameDIPHTHERIA TOXOID
    D.3.9.4EV Substance CodeSUB12489MIG
    D.3.10 Strength
    D.3.10.1Concentration unit LfU lime flocculation unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number16.7
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTETANUS TOXOID
    D.3.9.3Other descriptive nameTETANUS TOXOID
    D.3.9.4EV Substance CodeSUB12608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number26.7
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPERTUSSIS TOXOID
    D.3.9.3Other descriptive namePERTUSSIS TOXOID
    D.3.9.4EV Substance CodeSUB14817MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U 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 INNPERTUSSIS FILAMENTOUS HAEMAGGLUTININ
    D.3.9.3Other descriptive namePERTUSSIS FILAMENTOUS HAEMAGGLUTININ
    D.3.9.4EV Substance CodeSUB20298
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number4
    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.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
    Prevention of disease caused by a type of bacteria called Streptococcus pneumoniae (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
    1. To demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone when measured 1 month after the 3-dose infant series.
    2. To measure the immune response to 7vPnC 1 month after a 3-dose infant series as measured by serum immunoglobulin G (IgG) levels.
    3. To evaluate the safety profile of 7vPnC given with DTaP as measured by the incidence rates of local reactions, systemic events, and adverse events (AEs).
    E.2.2Secondary objectives of the trial
    1. To assess the immune response as measured by serum antibody responses to diphtheria toxin, tetanus toxin, PT and FHA induced by DTaP given with 7vPnC are comparable to the immune response induced by DTaP given alone when measured 1 month after the toddler dose.
    2. To measure the immune response to 7vPnC 1 month after the toddler dose as measured by serum IgG levels.
    3. To measure the immune response to 7vPnC 1 month after completion of catch-up doses as measured by serum IgG levels.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 3 to 6 months (defined as the first day the subject is 3 months of age to the last day the subject is 6 months of age) at time of enrollment.
    2. Available for entire study period and whose parent/legal guardian can be reached by telephone.
    3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
    4. Subject’s parent/legal guardian must be willing and able to comply with scheduled visits, treatment plan and other study procedures.
    5. Evidence of a personally signed and dated informed consent document indicating that the subject’s parent/legal guardian has been informed of all pertinent aspects of the study.
    E.4Principal exclusion criteria
    1. Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.
    2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
    3. Contraindication to vaccination with a pneumococcal conjugate, diphtheria, tetanus, or pertussis vaccines.
    4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
    5. Known or suspected immune deficiency or suppression.
    6. History of culture-proven invasive disease caused by S pneumoniae (example [e.g.], meningitis, bacteremia, osteomyelitis, arthritis).
    7. Major known congenital malformation or serious chronic disorder (eg, Down syndrome, diabetes, sickle cell anemia).
    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 (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis) within the past 3 months.
    10. Participation in other studies before the current study begins and/or during study participation.
    11. Subjects who are direct descendants (child, grandchild) of investigational site staff members or subjects who are direct descendants (child, grandchild) of Pfizer employees directly involved in the conduct of the trial.
    12. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or test drug 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.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of Subjects Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens (PT and FHA) 1 Month After the Infant Series
    Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series
    Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody (PT and FHA) 1 Month After the Infant Series
    Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
    Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month after the infant series
    E.5.2Secondary end point(s)
    A) -Percentage of Subjects Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens (PT and FHA) 1 Month After the Toddler Dose
    -Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
    -Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody (PT and FHA) 1 Month After the Toddler Dose
    -Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose
    -Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose

    B)- Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pre toddler Dose to 1 Month After the Toddler Dose

    C)-Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
    -Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3


    E.5.2.1Timepoint(s) of evaluation of this end point
    A) 1 month after the toddler dose
    B) Pre-toddler dose, 1 month after the toddler dose
    C) 1 month after the catch-up dose 3
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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? 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
    Japan
    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 years1
    E.8.9.2In all countries concerned by the trial months4
    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: 321
    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: 321
    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 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 between 3 months to 6 months of age
    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 321
    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: Japan
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