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    Summary
    EudraCT Number:2016-001117-25
    Sponsor's Protocol Code Number:V114-008
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-10
    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
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-001117-25
    A.3Full title of the trial
    A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants
    Ensayo de fase II, multicéntrico, aleatorizado y doble ciego para evaluar la seguridad, la tolerabilidad y la inmunogenicidad de V114 en comparación con Prevenar 13™ en lactantes sanos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II Clinical trial to evaluate the safety and immune effectiveness of V114 in healthy infants
    Ensayo Clínico en Fase II para evaluar la seguridad y eficacia inmune de V114 en lactantes sanos
    A.3.2Name or abbreviated title of the trial where available
    Saftey/Immunogenicity of Different Lots of V114 vs. Prevnar 13™ in Infants
    Seguridad e inmunogenicidad de diferentes lotes de V114 en comparación con Prevenar 13™ en lactantes
    A.4.1Sponsor's protocol code numberV114-008
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02987972
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme de España SA
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913210600
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.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 name15-Valent Pneumococcal Conjugate Vaccine adsorbed on Aluminum Phosphate
    D.3.2Product code V114 Lot1 (WL00067190)
    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 SEROTYPE 1
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1
    D.3.9.4EV Substance CodeSUB25373
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3
    D.3.9.4EV Substance CodeSUB25371
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4
    D.3.9.4EV Substance CodeSUB20576
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5
    D.3.9.4EV Substance CodeSUB25370
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A
    D.3.9.4EV Substance CodeSUB126381
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B
    D.3.9.4EV Substance CodeSUB20577
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F
    D.3.9.4EV Substance CodeSUB25369
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V
    D.3.9.4EV Substance CodeSUB20578
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14
    D.3.9.4EV Substance CodeSUB20579
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C
    D.3.9.4EV Substance CodeSUB20580
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A
    D.3.9.4EV Substance CodeSUB25361
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F
    D.3.9.4EV Substance CodeSUB20581
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F
    D.3.9.4EV Substance CodeSUB25359
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F
    D.3.9.4EV Substance CodeSUB20582
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F
    D.3.9.4EV Substance CodeSUB25326
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCORYNEBACTERIUM DIPHTHERIAE CRM197 CARRIER PROTEIN
    D.3.9.3Other descriptive nameCORYNEBACTERIUM DIPHTHERIAE CRM197 CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB25296
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32
    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 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 name15-Valent Pneumococcal Conjugate Vaccine adsorbed on Aluminum Phosphate
    D.3.2Product code V114 Lot2 (WL00067191)
    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 SEROTYPE 1
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1
    D.3.9.4EV Substance CodeSUB25373
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3
    D.3.9.4EV Substance CodeSUB25371
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4
    D.3.9.4EV Substance CodeSUB20576
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5
    D.3.9.4EV Substance CodeSUB25370
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A
    D.3.9.4EV Substance CodeSUB126381
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B
    D.3.9.4EV Substance CodeSUB20577
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F
    D.3.9.4EV Substance CodeSUB25369
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V
    D.3.9.4EV Substance CodeSUB20578
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14
    D.3.9.4EV Substance CodeSUB20579
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C
    D.3.9.4EV Substance CodeSUB20580
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A
    D.3.9.4EV Substance CodeSUB25361
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F
    D.3.9.4EV Substance CodeSUB20581
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F
    D.3.9.4EV Substance CodeSUB25359
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F
    D.3.9.4EV Substance CodeSUB20582
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F
    D.3.9.4EV Substance CodeSUB25326
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCORYNEBACTERIUM DIPHTHERIAE CRM197 CARRIER PROTEIN
    D.3.9.3Other descriptive nameCORYNEBACTERIUM DIPHTHERIAE CRM197 CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB25296
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32
    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 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.3.4Pharmaceutical 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 SEROTYPE 1
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1
    D.3.9.4EV Substance CodeSUB25373
    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 SEROTYPE 3
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3
    D.3.9.4EV Substance CodeSUB25371
    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 SEROTYPE 4
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4
    D.3.9.4EV Substance CodeSUB20576
    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 SEROTYPE 5
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5
    D.3.9.4EV Substance CodeSUB25370
    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 SEROTYPE 6A
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A
    D.3.9.4EV Substance CodeSUB126381
    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 SEROTYPE 6B
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B
    D.3.9.4EV Substance CodeSUB20577
    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 SEROTYPE 7F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F
    D.3.9.4EV Substance CodeSUB25369
    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 SEROTYPE 9V
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V
    D.3.9.4EV Substance CodeSUB20578
    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 SEROTYPE 14
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14
    D.3.9.4EV Substance CodeSUB20579
    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 SEROTYPE 18C
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C
    D.3.9.4EV Substance CodeSUB20580
    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 SEROTYPE 19A
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A
    D.3.9.4EV Substance CodeSUB25361
    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 SEROTYPE 19F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F
    D.3.9.4EV Substance CodeSUB20581
    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 SEROTYPE 23F
    D.3.9.3Other descriptive namePNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F
    D.3.9.4EV Substance CodeSUB20582
    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 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
    Prevention of pneumococcal disease
    Prevención de la enfermedad neumocócica
    E.1.1.1Medical condition in easily understood language
    Pneumococcal pneumonia
    Neumonía neumocócica
    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 19.1
    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
    In healthy infants receiving one of the 2 V114 lots or Prevnar 13™ at approximately 2, 4, 6, and 12-15 months of age:
    1.To describe the safety and tolerability profiles of 2 different lots of V114 [Lot 1 (V114-1), Lot 2 (V114-2)], after each dose
    2.To demonstrate that V114 (either V114-1 or V114-2) is non-inferior to Prevnar 13™ for the 13 shared serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), based on the proportion of subjects meeting serotype-specific immunoglobulin G (IgG) threshold value of ≥0.35 μg/mL at 1 month post-dose 3 (PD3)
    3.To evaluate the serotype-specific IgG geometric mean concentrations (GMCs) of V114-1, V114-2, and Prevnar 13™, and the IgG GMC ratios between each of the two V114 lots and Prevnar 13™ for all 15 serotypes included in V114 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) at 1 month PD3.
    En lactantes sanos que reciban uno de los dos lotes de V114 o Prevenar 13™ aproximadamente a los 2, 4, 6 y 12-15 meses de edad:
    1. Describir los perfiles de seguridad y tolerabilidad de dos lotes diferentes de V114 [Lote 1 (V114-1), Lote 2 (V114-2)], después de cada dosis.
    2. Demostrar que V114 (V114-1 o V114-2) no es inferior a Prevenar 13™ en relación con los 13 serotipos compartidos (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F y 23F), a tenor de la proporción de sujetos que alcancen el valor umbral de inmunoglobulina G (IgG) con especificidad serotípica ≥ 0,35 μg/ml un mes después de la tercera dosis.
    3. Evaluar la media geométrica de la concentración (MGC) de IgG con especificidad serotípica de V114-1, V114-2 y Prevenar 13™ y los cocientes de MGC de IgG entre cada uno de los dos lotes de V114 y Prevenar 13 ™ en relación con los 15 serotipos incluidos en V114 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F y 33F) un mes después de la tercera dosis
    E.2.2Secondary objectives of the trial
    To evaluate the serotype-specific IgG GMCs of V114-1, V114-2, and Prevnar 13™, and the IgG GMC ratios between each of the two V114 lots and Prevnar 13™ for all 15 serotypes included in V114 at pre-dose 4 and 1 month postdose 4 (PD4).
    Evaluar la MGC de IgG con especificidad serotípica de V114-1, V114-2 y Prevenar 13™ y los cocientes de MGC de IgG entre cada uno de los dos lotes de V114 y Prevenar 13 ™ en relación con los 15 serotipos incluidos en V114 antes y un mes después de la cuarta dosis.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood and buccal swabs)specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    Merck llevará a cabo investigaciones biomédicas futuras en muestras de ADN (sangre y frotis bucal) obtenidas durante este ensayo clínico. Estas investigaciones tendrán por objeto el análisis de biomarcadores para abordar aspectos nuevos que no se describen en otras partes del protocolo (como parte del ensayo principal) y solo se llevarán a cabo en muestras de los sujetos que hayan otorgado el consentimiento correspondiente. El objetivo de la obtención y conservación de muestras para investigaciones biomédicas futuras consiste en estudiar e identificar biomarcadores que proporcionen información a los científicos sobre las enfermedades y sus tratamientos. El objetivo último es utilizar tal información para desarrollar vacunas y fármacos más seguros y eficaces o para garantizar que los sujetos reciban la dosis correcta del fármaco o la vacuna adecuados en el momento preciso.
    E.3Principal inclusion criteria
    1.Be healthy (based on medical history and physical examination) male or female infant approximately 2 months of age (42 days to 90 days), inclusive
    2.Have a parent/legal guardian who understands the trial procedures, alternate treatments available, and risks involved with the trial.
    3.Have a parent/legal guardian who is able to read, understand, and complete the VRC and voluntarily agree to participate by giving written informed consent.
    4.A parent/legal guardian also acknowledges that they: a) will attend all scheduled visits b) comply with the trial procedures, and c) have access to a telephone.
    1. Ser lactantes sanos (a tenor de sus antecedentes médicos y la exploración física) de uno u otro sexo y de aproximadamente dos meses de edad (de 42 a 90 días, ambos inclusive).
    2. Tener un progenitor o tutor que comprenda los procedimientos del ensayo, los tratamientos alternativos disponibles y los riesgos que entraña el ensayo.
    3. Tener un progenitor o tutor que sepa leer, comprenda y sea capaz de cumplimentar la TV y que acepte voluntariamente participar otorgando su consentimiento informado por escrito.
    4. Tener un progenitor o tutor que también se comprometa a:
    a. Acudir a todas las visitas programadas.
    b. Cumplir los procedimientos del ensayo,
    c. Tener acceso a un teléfono.
    E.4Principal exclusion criteria
    If the subject meets criteria marked with an asterisk (*), the Day 1 Visit may be rescheduled for a time when these criteria are not met.
    1.Had prior administration of any pneumococcal vaccine
    2.Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine
    3.* Had a recent febrile illness (rectal temperature ≥38.1°C [≥100.5°F] or axillary temperature ≥37.8°C [≥100.0°F]) occurring within 72 hours prior to receipt of trial vaccine
    4.Has a known or suspected impairment of immunological function
    5. Has a history of congenital or acquired immunodeficiency (e.g. splenomegaly)
    6.Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
    7.Has or his/her mother has a documented hepatitis B surface antigen – positive test
    8.Has known or history of functional or anatomic asplenia
    9.Has a history of failure to thrive
    10.Has known or history of a coagulation disorder contraindicating intramuscular vaccination
    11.Has a history of autoimmune disease including systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, and other autoimmune disorders
    12.Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
    13.*Meets one or more of the following systemic corticosteroid exclusion criteria: a)Has received systemic corticosteroids (equivalent of ≥ 2 mg/kg total daily dose of prednisone or ≥ 20 mg/d for persons weighing > 10 kg) for ≥ 14 consecutive days and has not completed this course of treatment at least 30 days prior to trial randomization b)Has received systemic corticosteroids within 14 days prior to the first dose of vaccine at randomization c) Is expected to require systemic corticosteroids within 30 days after each vaccination during conduct of the trial
    14.*Has received other licensed non-live vaccines within the 14 days before receipt of first dose of trial vaccine
    15.*Has received a licensed live virus vaccine within the 30 days prior to receipt of first dose of trial vaccine
    16.Had prior receipt of a blood transfusion or blood products, including immunoglobulins
    17.Has participated in another clinical trial of an investigational product before the beginning or anytime during the duration of the current clinical trial. Subjects enrolled in observational studies may be included; these will be reviewed on a caseby- case basis for approval by the SPONSOR
    18.Has a history of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease
    19.Cannot be adequately followed for safety according to the protocol plan
    20.Has a parent/legal guardian who is unlikely to adhere to trial procedures, keep appointments, or is planning to relocate during the trial
    21.Has any other reason that in the opinion of the investigator may interfere with the evaluation required by the trial
    22.Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial
    1Cuando un sujeto cumpla los criterios marcados con un asterisco (*), la visita del día 1 podrá reprogramarse para un momento en el que no se cumplan dichos criterios.
    1. Administración previa de cualquier vacuna antineumocócica.
    2. Hipersensibilidad conocida a cualquier componente de la vacuna antineumocócica conjugada o a cualquier vacuna que contenga toxoide diftérico.
    3. *Enfermedad febril (temperatura rectal ≥ 38,1 ºC o axilar ≥ 37,8 ºC) reciente, en las 72 horas previas a la administración de la vacuna del ensayo.
    4. Sospecha o certeza de deterioro de la función inmunológica.
    5. Antecedentes de inmunodeficiencia congénita o adquirida (por ejemplo, esplenomegalia).
    6. Infección documentada por el virus de la inmunodeficiencia humana (VIH) del sujeto o su madre.
    7. Análisis positivo documentado de antígeno de superficie del virus de la hepatitis B en el sujeto o su madre.
    8. Presencia o antecedentes de asplenia funcional o anatómica.
    9. Antecedentes de retraso del crecimiento.
    10. Presencia o antecedentes de un trastorno de la coagulación que contraindique la vacunación intramuscular.
    11. Antecedentes de enfermedad autoinmunitaria, como lupus eritematoso sistémico, síndrome antifosfolipídico, enfermedad de Behçet, tiroidopatía autoinmunitaria, polimiositis y dermatomiositis, esclerodermia, diabetes mellitus de tipo 1 y otros trastornos autoinmunitarios.
    12. Presencia de un trastorno neurológico o cognitivo-conductual, como encefalitis/mielitis, encefalomielitis diseminada aguda, trastorno generalizado del desarrollo y otros trastornos relacionados.
    13. *Cumplimiento de uno o más de los siguientes criterios de exclusión relacionados con el uso de corticoides sistémicos:
    • Recepción de corticoides sistémicos (equivalente a una dosis diaria total ≥ 2 mg/kg de prednisona o ≥ 20 mg/día en sujetos que pesen > 10 kg) durante 14 días consecutivos o más, sin que se haya completado este ciclo de tratamiento al menos 30 días antes de la aleatorización en el ensayo.
    • Recepción de corticoides sistémicos en los 14 días previos a la primera dosis de la vacuna en el momento de aleatorización.
    • Previsión de la necesidad de corticoides sistémicos en los 30 días siguientes a cada vacunación durante la realización del ensayo.
    14. *Recepción de otras vacunas inactivadas autorizadas en los 14 días previos a la administración de la primera dosis de la vacuna del ensayo.
    15. *Recepción de una vacuna de virus vivos autorizada en los 30 días previos a la administración de la primera dosis de la vacuna del ensayo.
    16. Recepción previa de una transfusión de sangre o hemoderivados, incluidas inmunoglobulinas.
    17. Participación en otro ensayo clínico de un producto en investigación antes del comienzo de este ensayo clínico o en cualquier momento durante su transcurso. Podrán participar sujetos reclutados en estudios observacionales; se examinará cada caso con el fin de obtener la aprobación del promotor.
    18. Antecedentes de enfermedad neumocócica invasora (hemocultivo positivo, cultivo positivo de líquido cefalorraquídeo u otro sitio estéril) o de cualquier otra enfermedad neumocócica con cultivo positivo.
    19. Imposibilidad de un seguimiento adecuado en cuanto a seguridad de acuerdo con el plan del protocolo.
    20. Escasas probabilidades de que el progenitor o tutor del sujeto cumpla los procedimientos del ensayo o acuda a las citas o tiene previsto mudarse durante el ensayo
    21. Cualquier otro motivo que, en opinión del investigador, pueda interferir en la evaluación exigida por el ensayo.
    22. El sujeto o un familiar directo (por ejemplo, cónyuge, padre/madre o tutor legal, hermano o hijo) forma parte del personal del centro de investigación o del promotor implicado directamente en este ensayo
    E.5 End points
    E.5.1Primary end point(s)
    1. The proportion of subjects meeting serotype-specific IgG ≥0.35 μg/mL for the 13 serotypes shared with Prevnar 13™ measured by the Pn ECL assay at 1 month post-dose 3
    2. The serotype-specific IgG GMC for all 15 serotypes included in V114 measured by the Pn ECL assay at 1 month post-dose 3
    1. La proporción de sujetos con IgG específica del serotipo ≥0,35 μg/ml para los 13 serotipos compartidos con Prevnar 13™ determinada mediante el análisis de EQL Pn un mes después de la dosis 3.
    2. Las MGC de IgG para los 15 serotipos incluidos en V114 determinado mediante el análisis de EQL Pn un mes después de la dosis 3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 1 month post dose 3, For purposes of analysis and reporting, the overall trial ends when the Sponsor receives the last serological results
    Aproximadamente 1 mes después de la dosis 3. Para fines de análisis e informes, el ensayo general finaliza cuando el Promotor reciba los últimos resultados serológicos
    E.5.2Secondary end point(s)
    The serotype-specific IgG GMC for all 15 serotypes included in V114 measured by the Pn ECL assay at pre-dose 4 and 1 month post-dose 4.
    La MGC de IgG específico de serotipo para los 15 serotipos incluidos en V114 determinada mediante el análisis de EQL Pn antes de la dosis 4 y un mes después de la dosis 4
    E.5.2.1Timepoint(s) of evaluation of this end point
    pre-dose 4, and approximately 1 month post-dose 4
    Pre-dosis 4, y aproximadamente 1 mes después de la dosis 4
    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 Yes
    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
    Tolerability
    Tolerabilidad
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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) 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Canada
    Denmark
    Finland
    Israel
    Spain
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 1050
    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: 1050
    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 state53
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 176
    F.4.2.2In the whole clinical trial 1050
    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
    Ninguno
    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 Decision2017-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-30
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