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    Summary
    EudraCT Number:2017-001529-41
    Sponsor's Protocol Code Number:0887X1-4596
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-06-02
    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 number2017-001529-41
    A.3Full title of the trial
    Prevenar Post-Licensure Safety Study in Russia: Frequency Of Fever Post Vaccination
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevenar Study conducted in Russia
    A.4.1Sponsor's protocol code number0887X1-4596
    A.5.4Other Identifiers
    Name:B1841011Number:Alias ID
    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 E 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.govCallCenter@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
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationRussian Federation
    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 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 INNPrevenar
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (7-VALENT, ADSORBED)
    D.3.9.4EV Substance CodeSUB170332
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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.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
    Infants from 3 months up to 23 months of age who may benefit from active immunization against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) and who would be scheduled to receive Prevenar PCV-7.
    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
    The primary objective is to estimate the incidence of febrile reactions of ≥38 to ≤39°C; >39 to ≤40°C; >40°C occurring within 2 days following vaccination with Prevenar (PCV-7) coadministered with other routine childhood vaccines under the conditions of routine daily use in the Russian Federation within the licensed indication
    E.2.2Secondary objectives of the trial
    To observe the frequency and severity of other local and/or systemic reactions and undesirable effects for two days
    after routine vaccination with PCV-7
    a) Local reaction at the site of injection: Redness or induration ≥ 2cm in diameter, swelling including extent
    of swelling, transient tenderness and tenderness that interfered with limb movement.
    b) Systemic reaction:
    - to monitor the rate of other systemic reactions such as restless sleep, decreased appetite, unusual
    irritability/fussiness/crying, vomiting, diarrhea, drowsiness, other.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Infants from 3 months up to 23 months of age who may benefit from active immunization
    against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) and who would be scheduled to receive Prevenar PCV-7.
    2. Parents or legal guardians must be willing and able to complete the diary cards This is consistent with previous and ongoing studies, and is consistent with the anticipated Russian label.

    E.4Principal exclusion criteria
    1. Hypersensitivity to the active substances or to any of the excipients.
    2. Hypersensitivity to diphtheria toxoid
    3. Age less than 3 months or greater than or equal to 2 years at enrollment Contraindications
    as listed in the Package Insert / Russian SmPC for either Prevenar or for any
    concomitantly used other vaccines
    4. Previously vaccinated with 23-valent pneumococcal polysaccharide vaccine
    5. Current febrile illness (temperature greater than or equal to 38.0°C [100.4°F]) or other
    acute illness within 48 to 72 hours before Prevenar administration.
    6. Prophylactic use of non-steroidal anti-inflammatory medications and/or acetaminophen
    (e.g., paracetamol). However, acetaminophen/paracetamol may be administered for
    treatment of fever, pain, etc.
    7. The vaccine should not be given to infants or children with thrombocytopenia or any
    coagulation disorder that would contraindicate intramuscular injection.
    8. Received any investigational drugs, live vaccines or devices within 4 weeks before
    administration of the vaccine, other than on the day of study vaccination.
    E.5 End points
    E.5.1Primary end point(s)
    1)The incidence of febrile reactions more than 38.0 degrees Celsius,
    2)To observe the frequency and severity of other local and/or systemic reactions and undesirable effects for two days after routine vaccination with PCV-7
    3) Safety Analysis
    The following adverse events will be evaluated:
    Local reaction at the site of injection
    Redness including extent or redness
    Swelling including extent of swelling
    Induration
    Tenderness
    Systemic reaction
    Fever
    Decreased/increased need for sleep (restless sleep)
    Decreased Appetite
    Unusual irritability/fussiness/crying
    Vomiting
    Diarrhea
    Incidence of adverse events (as defined above) will be tabulated.
    Incidence of adverse events will be tabulated by subject’s baseline characteristics (age and sex), existence of
    co-morbid conditions, existence of concomitant medications, existence of concomitant vaccine and type, etc.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects will be observed in the healthcare centre for 30 minutes following vaccination for immediate local or
    systemic reactions. Safety evaluation will be based on frequency of adverse events occurring within the 2 -day
    post-vaccination period for all subjects who received at least one dose of PCV-7.
    During the interval from vaccination through 1 week, the parent or legal guardian will complete a diary card and
    report their child’s temperature taken on a daily basis in the evening, measured by ear thermometry. All febrile
    episodes experienced at home, interventions related to and management of the febrile episode, use of antipyretic
    medication and all medically attended events during the interval will be recorded
    E.5.2Secondary end point(s)
    NONE
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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
    Non-Interventional
    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 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
    Russian Federation
    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
    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: 100
    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: 100
    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
    children under the age of 18
    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 100
    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: Russian Federation
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