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    Summary
    EudraCT Number:2011-006161-18
    Sponsor's Protocol Code Number:115650
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-07
    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
    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 ConcernedFinland - Fimea
    A.2EudraCT number2011-006161-18
    A.3Full title of the trial
    A phase IIIA, randomized, observer-blind, controlled, multinational study to evaluate the safety and immunogenicity of GSK Biologicals' MMR vaccine (209762) (Priorix®) compared to Merck & Co., Inc.’s MMR vaccine (M M R®II or VaxPro), as a first dose, both co-administered with Varivax, Havrix (all subjects) and Prevnar 13 (US subset) in healthy children 12 to 15 months of age
    Vaiheen IIIA, satunnaistettu, havainnoijan suhteen sokkoutettu,
    kontrolloitu, monikansallinen tutkimus, jossa arvioidaan GSK Biologicalsin
    MMR-rokotteen (209762) turvallisuustta ja immunogeenisuutta verrattuna
    Merck & Co., Inc:n MMR-rokotteeseen, kun molemmat annetaan
    samanaikaisesti Varivax, Havrix ja Prevnar 13 (osaryhmä) -rokotteiden
    kanssa terveille lapsille toisen ikävuoden aikana
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and immunogenicity study of GSK Biologicals’ MMR vaccine (209762) comparing immunogenicity and safety to Merck & Co., Inc.’s MMR vaccine, in healthy children 12 to 15 months of age
    Turvallisuus- ja immunogeenisuustutkimus, jossa verrataan GSK
    Biologicalsin MMR-rokotteen (209762) immunogeenisuutta ja
    turvallisuutta Merck & Co., Inc.:n MMR-rokotteeseen terveillä 12-15
    kuukauden ikäisillä lapsilla.
    A.3.2Name or abbreviated title of the trial where available
    MMR-162
    A.4.1Sponsor's protocol code number115650
    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 SponsorGlaxoSmithKline Biologicals
    B.1.3.4CountryBelgium
    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 supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de l’Institut, 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number442089904466
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 Priorix® (GSK Biologicals' measles, mumps, and rubella vaccine live)
    D.2.1.1.2Name of the Marketing Authorisation holderGSK Biologicals
    D.2.1.2Country which granted the Marketing AuthorisationEstonia
    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 Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNLive attenuated measles virus (Schwarz strain)
    D.3.9.3Other descriptive nameMEASLES VIRUS SCHWARZ STRAIN (LIVE, ATTENUATED)
    D.3.9.4EV Substance CodeSUB25680
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number4.8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive attenuated mumps virus (RIT4385 strain)
    D.3.9.3Other descriptive nameMUMPS VIRUS VACCINE LIVE (JERYL LYNN)
    D.3.9.4EV Substance CodeSUB21041
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number5.8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive attenuated rubella virus (Wistar RA 27/3 strain)
    D.3.9.3Other descriptive nameRUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED)
    D.3.9.4EV Substance CodeSUB21610
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number4.7
    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 M-M-R VAXPRO
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD 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.3.4Pharmaceutical form Powder and solvent for suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    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 INNMEASLES VIRUS ENDERS' EDMONSTON STRAIN (LIVE, ATTENUATED)
    D.3.9.3Other descriptive nameMEASLES VIRUS ENDERS' EDMONSTON STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS
    D.3.9.4EV Substance CodeSUB25310
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive attenuated mumps virus (Jeryl Lynn™ (level B) strain)
    D.3.9.3Other descriptive nameMUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED) PRODUCED IN CHICK EMBRYO CELLS
    D.3.9.4EV Substance CodeSUB25309
    D.3.10 Strength
    D.3.10.1Concentration unit CCID50/dose cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number12500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive attenuated rubella virus (Wistar RA 27/3 strain)
    D.3.9.3Other descriptive nameRUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED) PRODUCED IN WI-38 HUMAN DIPLOID LUNG FIBROBLASTS
    D.3.9.4EV Substance CodeSUB25308
    D.3.10 Strength
    D.3.10.1Concentration unit log10 CCID50/dose log10 cell culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.0
    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: 3
    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 Havrix junior 720 (GSK Biological Hepatitis A virus antigen (HAV))
    D.2.1.1.2Name of the Marketing Authorisation holderGSK Biologicals
    D.2.1.2Country which granted the Marketing AuthorisationEstonia
    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 IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHEPATITIS A VIRUS ANTIGEN (INACTIVATED)
    D.3.9.2Current sponsor codeHAV
    D.3.9.3Other descriptive nameHEPATITIS A VIRUS ANTIGEN (INACTIVATED)
    D.3.9.4EV Substance CodeSUB38555
    D.3.10 Strength
    D.3.10.1Concentration unit ELISA unit enzyme-linked immunosorbent assay unit
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number720
    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: 4
    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 Varivax (Merck & Co. Inc.'s Live attenuated Varicella (OKA/Merck strain),
    D.2.1.1.2Name of the Marketing Authorisation holderMerck & Co., Inc.
    D.2.1.2Country which granted the Marketing AuthorisationEstonia
    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 Powder and solvent for 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 INNVARICELLA VIRUS OKA/MERCK STRAIN, (LIVE, ATTENUATED) PRODUCED IN HUMAN
    D.3.9.3Other descriptive nameVARICELLA VIRUS OKA/MERCK STRAIN, (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS
    D.3.9.4EV Substance CodeSUB25312
    D.3.10 Strength
    D.3.10.1Concentration unit PFU/dose plaque forming unit(s)/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number1350
    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
    Healthy volunteers (Active immunization against measles, mumps and rubella diseases in healthy children, 12 to 15 months of age)
    E.1.1.1Medical condition in easily understood language
    Common childhood illness, measles, mumps and rubella diseases.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10069547
    E.1.2Term Mumps immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10039276
    E.1.2Term Rubella with unspecified complications
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10039274
    E.1.2Term Rubella with other specified complication
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10069545
    E.1.2Term Measles immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10069564
    E.1.2Term Rubella immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10028276
    E.1.2Term Mumps with unspecified complication
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10027015
    E.1.2Term Measles like illness
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10028275
    E.1.2Term Mumps with other specified complications
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10027021
    E.1.2Term Measles without mention of complication
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10027020
    E.1.2Term Measles with unspecified complication
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10027022
    E.1.2Term Measles-like rash
    E.1.2System Organ Class 100000004858
    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 the safety profile (fever >39.0°C (>102.2°F)) of Inv_MMR compared to Com_MMR (pooled lots) when co-administered with VV and HAV (to all children) and PCV-13 (only to children enrolled in the US).
    • To demonstrate the safety profile (fever ≥38.0°C (≥100.4°F)) of Inv_MMR compared to Com_MMR (pooled lots) when co-administered with VV and HAV (to all children) and PCV-13 (children enrolled in the US)
    E.2.2Secondary objectives of the trial
    • To assess the immunogenicity of Inv_MMR and Com_MMR in terms of seroresponse and GMCs for anti-measles, anti-mumps and anti-rubella virus antibodies at Day 42.
    • To assess safety and reactogenicity of Inv_MMR and Com_MMR when co-administered with Varivax and Havrix (to all children) and Prevnar 13 (only to children enrolled in the US).
    • To assess any measles-like illness occurring within 5-12 days after vaccination
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female child between 12 and 15 months of age (e.g., from the 1 year birthday until the day before age 16 months) at the time of vaccination.
    • Subjects’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, respects intervals between visits).
    • Written informed consent obtained from the parent(s)/LAR(s) of the child.
    • Child is in stable health as determined by investigator’s clinical examination and assessment of child’s medical history.
    • For US children only: a child who received all routine vaccinations as per ACIP recommendations prior to study entry: completion of hepatitis B and rotavirus series and completion of the primary series of diphtheria, tetanus, pertussis, poliovirus, Haemophilus influenzae type b (Hib) and pneumococcal vaccines. The 3-dose infant series of Prevnar 13 should be completed at least 60 days prior to study vaccination
    E.4Principal exclusion criteria
    • Child in care.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the period starting 30 days before the day of study vaccination (i.e., 30 days prior to Day 0) or planned use during the entire study period.
    • Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
    • Chronic administration (defined as 14 or more consecutive days) of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the study vaccination at Visit 1 or any planned administration of immunosuppressive and immune-modifying drugs during the entire study.
     For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day or equivalent.
     Inhaled and topical steroids are allowed.
    • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the day of study vaccination at Visit 1 and ending at Visit 2. Please Note:
     Inactivated influenza (Flu) vaccine and monovalent Haemophilus influenzae type b conjugate vaccine (Hib) vaccines may be given at any time, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s).
     Any other age appropriate vaccine may be given starting at Visit 2 and anytime thereafter.
    • Administration of immunoglobulins and/or any blood products during the period starting 180 days before the study vaccination at Visit 1 or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2.
    • History of measles, mumps, rubella, varicella/zoster and/or hepatitis A disease.
    • Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting within 30 days prior to first study vaccination.
    • Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella virus.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
    • Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
    • 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 hypersensitivity to neomycin, latex or gelatin.
    • Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). Fever is defined as temperature ≥38.0°C/100.4°F by any age appropriate route. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever.
    • Active untreated tuberculosis based on medical history.
    • Any other condition which, in the opinion of the investigator, prevents the child from participating in the study.
    • For US children only: a child that previously received a fourth dose of PCV-13 vaccine.
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of fever.
    - Occurrence of fever > 39.0°C (>102.2°F) from Day 5 through Day 12
    - Occurrence of fever ≥ 38.0°C (≥100.4°F) from Day 5 through Day 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Day 5 through Day 12
    E.5.2Secondary end point(s)
    • Immunogenicity of the MMR vaccines at Day 42.
    • Seroresponse to measles, mumps and rubella viruses by ELISA. Mumps seroresponse may be assessed by Plaque Reduction Neutralization Test (PRNT) rather than ELISA for a subset of subjects when the Pharmaceutical Product Development, Inc. (PPD) ELISA will no longer be available. If performed, this testing will be used for the identification of suboptimal responders. (NB: Descriptive statistics and reverse cumulative curves will only be calculated for the PRNT assay if at least 30 subjects have valid post-vaccination titers. Otherwise only a line listing of PRNT titers will be generated.)
    • Measles, mumps and rubella virus antibody concentrations by ELISA. Mumps virus antibody titers may be assessed by PRNT rather than ELISA for a subset of subjects, when mumps PPD ELISA will no longer be available. If performed, this testing will be used for the identification of suboptimal responders. (NB: Descriptive statistics and reverse cumulative curves will only be calculated for the PRNT assay if at least 30 subjects have valid post-vaccination titers. Otherwise only a line listing of PRNT titers will be generated.)
    • Solicited local and general symptoms.
    • Occurrence of solicited local symptoms in terms of injection site redness, pain and swelling from Day 0 to Day 3 after vaccination.
    • Occurrence of solicited general symptoms in terms of drowsiness, loss of appetite and irritability from Day 0 to Day 14 after vaccination.
    • Occurrence of solicited general symptoms in terms of fever (temperature ≥38.0°C / 100.4°F), rash, parotid/salivary gland swelling, any sign of meningism (including febrile convulsions) from Day 0 to Day 42 after vaccination.
    • Unsolicited adverse events.
    • Occurrence of unsolicited symptoms, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification, from Day 0 to Day 42 after vaccination.
    • Adverse events of specific interest.
    • Occurrence of new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits from Day 0 through the end of study.
    • Serious adverse events.
    • Occurrence of serious adverse events from Day 0 through the end of study.
    • Measles-like illness
    • Occurrence of any measles-like illness from Day 5 through Day 12 post vaccination
    Measles-like illness is defined as the occurrence of the following signs/symptoms in the absence of another confirmed diagnosis (e.g. laboratory confirmed scarlet fever):
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Day 42 after vaccination for Immunogenicity
    At Day 0 to 3 for Local symptoms
    At Day 0 to 14 for drowsiness, loss of appetite and irritability
    Day 0 to Day 42 for fever (temperature ≥38.0°C / 100.4°F), rash, parotid/salivary gland swelling, any sign of meningism (including febrile convulsions)
    At Day 0-42 for unsolicited symptoms
    At Day 0-180 for Serious AEs and new onset chronic illness (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.
    At Day 5 through Day 12 for measles like illness.



    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Observer blinded
    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 trial3
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Estonia
    Finland
    Puerto Rico
    Taiwan
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days21
    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: 1734
    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: 1734
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 476
    F.4.2.2In the whole clinical trial 1734
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-22
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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