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    Summary
    EudraCT Number:2005-005944-22
    Sponsor's Protocol Code Number:106670
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-28
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2005-005944-22
    A.3Full title of the trial
    Open, multicenter, randomised, controlled phase IIIb study evaluating the immunogenicity and safety of subcutaneous versus intramuscular administration of GlaxoSmithKline Biologicals’ combined measles-mumps-rubella-varicella vaccine (MeMuRu-OKA) to healthy children aged 11 to 21 months.
    A.3.2Name or abbreviated title of the trial where available
    MeMuRu-Oka-048
    A.4.1Sponsor's protocol code number106670
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline GmbH & Co. KG
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 namePriorix-Tetra
    D.3.2Product code MeMuRu-Oka
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive attenuated mumps vaccine, Jeryl Lynn strain
    D.3.10 Strength
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number4.4 log10 CCID50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive attenuated measles vaccine, Schwarz strain
    D.3.10 Strength
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.0 log10 CCID50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive attenuated rubella vaccine, RA 27/3 strain
    D.3.10 Strength
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.0 log10 CCID50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive attenuated varicella vaccine, OKA strain
    D.3.10 Strength
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.3 log10 PFU
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    Active immunization of healthy children aged 11 to 21 months against measles, mumps, rebella and varicella diseases
    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 evaluate GMT and seroconversion rate to VZV before and after intramuscular and subcutaneous injection of GSK’s MeMuRu-OKA vaccine.

    E.2.2Secondary objectives of the trial
    •To evaluate the cell-mediated immunity to varicella and measles after intramuscular and subcutaneous injection of GSK’s MeMuRu-OKA vaccine.
    •To quantify the immediate vaccination pain after intramuscular and subcutaneous injection of GSK’s MeMuRu-OKA vaccine.
    •To evaluate GMT and seroconversion rate to measles, mumps, and rubella, after intramuscular and subcutaneous injection of GSK’s MeMuRu-OKA vaccine.
    •To evaluate incidence, nature and severity of local, general, and serious adverse events after intramuscular and subcutaneous injection of GSK’s MeMuRu-OKA vaccine.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
    •Birth weight > 2000g.
    •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, collection of blood samples) should be enrolled in the study.
    •A male or female between 11 and 21 months of age at the time of the first vaccination if the investigator can assure that the subject will receive the second vaccination within an interval of 6 to 8 weeks and before the second birthday.
    •Written informed consent obtained from the parent or guardian of the subject before any study procedure.
    E.4Principal exclusion criteria
    •Previous vaccination against measles, mumps, rubella and/or varicella.
    •History of previous measles, mumps, rubella and/or varicella/zoster diseases.
    •Children from pregnant mothers who have a negative history of chickenpox.
    •Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the present trial.
    •Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    •Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisone, or equivalent,  0.5 mg/kg/day. Inhaled steroids are allowed).
    •Chronical administration of salicylates
    •Administration of a licensed vaccine not foreseen by the study protocol during the period starting from 30 days prior to study start and until study end (week 12)
    •Children who have received immunoglobulins and/or any blood products within six months preceding the first dose or with planned administration of any of these products during the study period.
    •Confirmed or suspected tuberculosis.
    •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, or a family history of congenital or hereditary immunodeficiency.
    •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including obvious allergic reactions to neomycin and/or egg proteins.
    •Major congenital defects or serious chronic illness.
    •History of any progressive neurologic disorders or seizures.
    •Acute disease* at the time of enrolment.
    •Residence in a household in which a person with high risk resides (e.g., newborns between 0-4 weeks old of mothers with negative history of chickenpox and without recorded vaccination against chickenpox, susceptible immunocompromised persons including those with HIV)
    •Rectal temperature  38.0 °C (100.4 °F) at time of vaccination.
    E.5 End points
    E.5.1Primary end point(s)
    •Seroconversion rate to VZV after intramuscular and subcutaneous injection of GSK’s MeMuRu-OKA vaccine, 42-56 days after Visit 2.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Yes
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 trial is the last study visit (visit 3)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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
    Age of subjects included in the trial is 11 -21 months
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state330
    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)
    Subjects with a suboptimal response to any of the four antigens after the second dose will be offered an additional dose of a commercialised MMR and/or varicella vaccine.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-21
    P. End of Trial
    P.End of Trial StatusCompleted
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