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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41465   clinical trials with a EudraCT protocol, of which   6815   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2012-005547-24
    Sponsor's Protocol Code Number:HXM01C
    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:2013-01-29
    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 number2012-005547-24
    A.3Full title of the trial
    A phase III open-label randomised study to evaluate the immunogenicity and safety of the concomitant administration of a new Hexavalent DTaP-IPV-HepB-PRP-T combined vaccine (Hexavalent vaccine) given at 2, 3, and 4 months of age with a meningococcal serogroup C conjugate (MenC) vaccine given at 2 and 4 months of age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Administration of a new hexavalent vaccine (Hexavalent vaccine) with a meningococcal serogroup C conjugate vaccine in healthy infants during primary series immunisation and booster vaccination
    A.4.1Sponsor's protocol code numberHXM01C
    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 SponsorSanofi Pasteur MSD
    B.1.3.4CountryFrance
    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 supportSanofi Pasteur MSD-SNC
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportSanofi Pasteur
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur MSD S.N.C.
    B.5.2Functional name of contact pointClinical Development Director
    B.5.3 Address:
    B.5.3.1Street Address162 avenue Jean Jaurès, CS 50712
    B.5.3.2Town/ cityLyon Cedex 07
    B.5.3.3Post code69367
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 4 37284000
    B.5.5Fax number+33 4 37284451
    B.5.6E-mailclinicaldevelopment@spmsd.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 Hexyon
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD SNC
    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 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 INNDIPHTHERIA TOXOID
    D.3.9.2Current sponsor codeD
    D.3.9.3Other descriptive nameDIPHTHERIA TOXOID
    D.3.9.4EV Substance CodeSUB12489MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTETANUS TOXOID
    D.3.9.2Current sponsor codeT
    D.3.9.3Other descriptive nameTETANUS TOXOID
    D.3.9.4EV Substance CodeSUB12608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPERTUSSIS TOXOID
    D.3.9.2Current sponsor codePT
    D.3.9.3Other descriptive namePERTUSSIS TOXOID
    D.3.9.4EV Substance CodeSUB14817MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFILAMENTOUS HAEMAGGLUTININ
    D.3.9.2Current sponsor codeFHA
    D.3.9.3Other descriptive namePERTUSSIS FILAMENTOUS HAEMAGGLUTININ
    D.3.9.4EV Substance CodeSUB20298
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINACTIVATED TYPE 1 POLIOVIRUS (MAHONEY)
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25669
    D.3.10 Strength
    D.3.10.1Concentration unit DAgU D antigen unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINACTIVATED TYPE 2 POLIOVIRUS (MEF-1)
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25670
    D.3.10 Strength
    D.3.10.1Concentration unit DAgU D antigen unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINACTIVATED TYPE 3 POLIOVIRUS (SAUKETT)
    D.3.9.2Current sponsor codeIPV
    D.3.9.3Other descriptive namePOLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25671
    D.3.10 Strength
    D.3.10.1Concentration unit DAgU D antigen unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHEPATITIS B SURFACE ANTIGEN
    D.3.9.2Current sponsor codeHep B
    D.3.9.3Other descriptive nameHEPATITIS B SURFACE ANTIGEN
    D.3.9.4EV Substance CodeSUB14083MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHAEMOPHILUS INFLUENSAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE) CONJUGATED TO TETANUS PROTEIN
    D.3.9.2Current sponsor codePRP-T
    D.3.9.3Other descriptive nameHAEMOPHILUS TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE) CONJUGATED TO TETANUS PROTEIN (22-36 µg)
    D.3.9.4EV Substance CodeSUB25275
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name NeisVac-C®
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 INNNEISSERIA MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE (DE-O-ACETYLATED) CONJUGATED TO TETANUS TOXOID
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE (DE-O-ACETYLATED) CONJUGATED TO TETANUS TOXOID (10-20 µg)
    D.3.9.4EV Substance CodeSUB26116
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 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.3.8 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.3.10 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.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.4
    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 RotaTeq®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD, SNC
    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 Oral solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROTAVIRUS SEROTYPE G1 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
    D.3.9.3Other descriptive nameROTAVIRUS SEROTYPE G1 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25315
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2200000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROTAVIRUS SEROTYPE G2 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
    D.3.9.3Other descriptive nameROTAVIRUS SEROTYPE G2 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25325
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2800000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROTAVIRUS SEROTYPE G3 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
    D.3.9.3Other descriptive nameROTAVIRUS SEROTYPE G3 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25335
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2200000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROTAVIRUS SEROTYPE G4 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
    D.3.9.3Other descriptive nameROTAVIRUS SEROTYPE G4 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB25323
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2000000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROTAVIRUS SEROTYPE P1A[8] HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
    D.3.9.3Other descriptive nameROTAVIRUS SEROTYPE P1A[8] HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
    D.3.9.4EV Substance CodeSUB89281
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2300000
    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: 5
    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 Nimenrix
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals S.A.
    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 solution for injection in pre-filled syringe
    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 INNNeisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.3Other descriptive nameNeisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.4EV Substance CodeSUB36480
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.3Other descriptive nameNeisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.4EV Substance CodeSUB36481
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.3Other descriptive nameNeisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.4EV Substance CodeSUB36482
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.3Other descriptive nameNeisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.4EV Substance CodeSUB36479
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 infants 46 to 74 days of age (both inclusive)
    E.1.1.1Medical condition in easily understood language
    Healthy infants 46 to 74 days of age (both inclusive)
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10054187
    E.1.2Term Polio immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10069543
    E.1.2Term Hemophilus influenzae type b immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10069593
    E.1.2Term Pertussis immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10054181
    E.1.2Term Hepatitis B immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10054180
    E.1.2Term Diphtheria immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10054183
    E.1.2Term Tetanus immunization
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    PRIMARY SERIES:
    - To demonstrate that the concomitant administration of the hexavalent vaccine given at 2, 3 and 4 months of age with a meningococcal serogroup C conjugate (MenC) vaccine given at 2 and 4 months of age is non inferior to the administration of the hexavalent vaccine without a MenC vaccine concomitantly in term of seroprotection rate for hepatitis B one month after the third dose of the hexavalent vaccine.
    - To demonstrate that the concomitant administration of a MenC vaccine given at 2 and 4 months of age with the hexavalent vaccine given at 2, 3 and 4 months of age induces an acceptable response for MenC in term of seroprotection rate (SPR) one month after the second dose of MenC.

    BOOSTER:
    To describe the immunogenicity of a booster dose of the hexavalent vaccine and of a meningococcal group ACWY conjugate vaccine either co-administered at 12 months of age or given separately.
    E.2.2Secondary objectives of the trial
    PRIMARY SERIES:
    Immunogenicity:
    -To describe the antibody response to all the hexavalent vaccine antigens one month after the third dose of the hexavalent vaccine when given concomitantly or not to MenC vaccine.
    -To describe the antibody response to MenC vaccine when a MenC vaccine is given concomitantly with the hexavalent vaccine, one month after the first and the second dose of MenC vaccine.
    Safety:
    -To describe the safety profile of the hexavalent vaccine after each and any injection when given concomitantly or not with a MenC vaccine.

    BOOSTER:
    Immunogenicity:
    To describe the antibody (Ab) persistence at 12 months of age for the hexavalent valences following a 3-dose primary vaccination at 2, 3 and 4 months of age (prior to administration of a booster dose)
    Safety:
    To describe the safety of a booster dose of the hexavalent vaccine and of a meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months of age or given separately.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    PRIMARY SERIES:
    1. Healthy infant 46 to 74 days of age (both inclusive)
    2. Born at full term of pregnancy (≥37 weeks) and/or with a birth weight≥2.5 kg
    3. Informed consent signed by the subject's parent(s) or legal representative
    4. Subject's parent(s) or legal representative able to comply with the study procedures
    such as adherence to study visits and completion of the diary cards
    5. Covered by health insurance

    BOOSTER:
    1. Infant who received 3 doses of the hexavalent vaccine in the Primary series
    2. Healthy infant from 12 months of age
    3. Informed consent signed by the subject's parent(s) or legal representative
    E.4Principal exclusion criteria
    PRIMARY SERIES:
    1. Participation at the time of study enrolment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
    2. Receipt of any vaccine in the 4 weeks preceding each study vaccination or planned receipt of a vaccine in the 4 weeks following each study vaccine administration
    3. Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, meningococcal, pneumococcal, rotavirus infection
    4. Know or suspected congenital, hereditary or acquired immunodeficiency or other immunosuppressive or immunodeficiency condition
    5. History of seizures or encephalopathy
    6. Known thrombocytopenia, as reported by the subject's parent or legal representative
    7. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
    8. Chronic illness that, in the opinion of the investigators, is at a stage where it might interfere with trial conduct or completion
    9. Known or suspected hypersensitivity to any of the study vaccines' active substance or excipients or history of a life-threatening reaction to a vaccine(s) containing the same substances as the study vaccines
    10. Contraindication to any of the study vaccines as per their Summary of Product Characteristics
    11. Known personal or maternal history of hepatitis B (HBs Ag) or hepatitis C seropositivity
    12. History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b or meningococcal serogroup C infection
    13. Receipt of immune globulin, blood or blood-derived products since birth
    14. Receipt of immunosuppressive therapy or other immune-modifying drugs, such as anticancer chemotherapy or radiation therapy since birth
    15. Receipt of systemic corticosteroid therapy for more than 14 consecutive days since birth
    16. Identified as a natural or adopted child of the investigator or employee with direct involvement in the current study.

    BOOSTER:
    1. Prior (in the last 4 weeks), current or planned participation in another clinical study investigating a vaccine, drug, medical device, or medical procedure during the entire duration of the Booster vaccination
    2. Receipt of a flu vaccine in the 2 weeks preceding vaccination at Visit 5 or receipt of any vaccine in the 4 weeks preceding vaccination at Visit 5 or planned receipt of a vaccine in the 4 weeks following vaccination at Visit 5
    3. Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, meningococcal, pneumococcal infections with either the trial vaccine or another vaccine
    4. History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b or meningococcal serogroup A, C, W or Y infection(s) confirmed either clinically, serologically, or microbiologically
    5. Known or suspected hypersensitivity to any of the active substance or excipients or trace residuals of the hexavalent vaccine or the meningococcal group ACWY conjugate vaccine, to any pertussis vaccine, history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines
    6. Contraindication to the hexavalent vaccine or the meningococcal group ACWY conjugate vaccine, as per their Summary of Product Characteristics
    7. Receipt of immune globulin, blood or blood-derived products in the last 3 months
    8. Receipt of immunosuppressive therapy or other immune-modifying drugs, such as anti-cancer chemotherapy or radiation therapy in the last 3 months
    9. Receipt of systemic corticosteroid therapy for more than 14 consecutive days in the last 3 months
    10. Known or suspected congenital, hereditary or acquired immunodeficiency or other immunosuppressive or immunodeficiency condition
    11. History of seizures or encephalopathy; uncontrolled neurologic disorder or uncontrolled epilepsy
    12. Known thrombocytopenia, as reported by the subject's parent(s) or legal representative
    13. Bleeding disorder, or receipt of anticoagulants in the last 3 weeks, contraindicating intramuscular injection
    14. Chronic illness that, in the opinion of the investigators, is at a stage where it might interfere with trial conduct or completion
    E.5 End points
    E.5.1Primary end point(s)
    PRIMARY SERIES
    Immunogenicity:
    - Proportion of subjects with an anti-HBs concentration ≥10 mIU/mL
    - Proportion of subjects with an anti-MenC titre ≥1:8 dil

    BOOSTER:
    Immunogenicity of hexavalent vaccine:
    -Proportion of subjects with an anti-D concentration ≥0.1 IU/mL
    -Proportion of subjects with an anti-D concentration ≥1.0 IU/mL
    -Proportion of subjects with an anti-T concentration ≥0.1 IU/mL
    -Proportion of subjects with an anti-T concentration ≥1.0 IU/mL
    -Proportion of subjects with an anti-IPV1 titres ≥1:8 dil
    -Proportion of subjects with an anti-IPV2 titres ≥1:8 dil
    -Proportion of subjects with an anti-IPV3 titres ≥1:8 dil
    -Proportion of subjects with an anti-HBs concentration ≥10 mIU/mL
    -Proportion of subjects with an anti-HBs concentration ≥100 mIU/mL
    -Proportion of subjects with an anti-PRP concentration ≥0.15 μg/mL
    -Proportion of subjects with an anti-PRP concentration ≥1.0 μg/mL
    -Booster response for pertussis antigens (PT and FHA) defined as follows:
    - Post-booster Ab concentrations ≥4-fold rise if pre-booster Ab concentrations <4x LLOQ
    - Post-booster Ab concentrations ≥2-fold rise if pre-booster Ab concentrations ≥4x LLOQ
    -Anti-PT ≥4-fold Ab concentrations increase from pre- (Visit 5) to post-booster (Visit 6)
    -Anti-FHA ≥4-fold Ab concentrations increase from pre- (Visit 5) to post-booster (Visit 6)
    -Anti-D GMC
    -Anti-T GMC
    -Anti-IPV1 GMTs
    -Anti-IPV2 GMTs
    -Anti-IPV3 GMTs
    -Anti-HBs GMC
    -Anti-PRP GMC
    -Anti-PT GMCs
    -Anti-FHA GMCs

    Immunogenicity of MenACWY vaccine:
    -Proportion of subjects with an anti-MenA titre ≥1:8 dil
    -Proportion of subjects with an anti-MenC titre ≥1:8 dil
    -Proportion of subjects with an anti-MenW-135 titre ≥1:8 dil
    -Proportion of subjects with an anti-MenY titre ≥1:8 dil
    -Anti-MenA GMTs
    -Anti-MenC GMTs
    -Anti-MenW-135 GMTs
    -Anti-MenY GMTs
    E.5.1.1Timepoint(s) of evaluation of this end point
    PRIMARY SERIES:
    One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine.

    BOOSTER:
    One month after administration of hexavalent and/or MenACWY (at 13 months of age)
    E.5.2Secondary end point(s)
    PRIMARY SERIES:
    Immunogenicity:
    - Anti-HBs geometric mean concentrations (GMC)
    - Proportion of subjects with an anti-PRP concentration ≥0.15 µg/mL
    - Anti-PRP GMC
    - Proportion of subjects with an anti-diphtheria (D) concentration ≥0.1 IU/mL
    - Proportion of subjects with an anti-D concentration ≥0.01 IU/mL
    - Anti-D geometric mean concentration (GMC)
    - Proportion of subjects with an anti-tetanus (T) concentration ≥0.1 IU/mL
    - Proportion of subjects with an anti-T concentration ≥0.01 IU/mL
    - Anti-T GMC
    - Proportion of subjects with an anti-inactivated poliovirus (IPV)1 titre ≥1:8 dil
    - Proportion of subjects with an anti-IPV2 titre ≥1:8 dil
    - Proportion of subjects with an anti-IPV3 titre ≥1:8 dil
    - Anti-IPV1, anti-IPV2 and anti-IPV3 GMTs
    - Proportion of subjects with an anti-PT vaccine response
    - Proportion of subjects with anti-FHA vaccine response
    - Anti-PT and anti-FHA GMCs
    - Anti-PT and anti-FHA GMCRs
    - Anti-PT and anti-FHA 4-fold increase

    - Proportion of subjects with an anti-MenC titre ≥1:8 dil
    - Proportion of subjects with an anti-MenC titre ≥1:128 dil

    - Anti-MenC GMT

    Safety:
    - Incidence of solicited injection-sites reactions and solicited systemic adverse event.
    - Incidence of unsolicited injection-site reactions, unsolicited systemic adverse events and all serious adverse events.

    BOOSTER:
    Immunogenicity, hexavalent vaccine:
    -Proportion of subjects with an anti-D concentration ≥0.01 IU/mL
    -Proportion of subjects with an anti-D concentration ≥0.1 IU/mL
    -Proportion of subjects with an anti-T concentration ≥0.01 IU/mL
    -Proportion of subjects with an anti-T concentration ≥0.1 IU/mL
    -Proportion of subjects with an anti-IPV1 titre ≥1:8 dil
    -Proportion of subjects with an anti-IPV2 titre ≥1:8 dil
    -Proportion of subjects with an anti-IPV3 titre ≥1:8 dil
    -Proportion of subjects with an anti-HBs concentration ≥10 mIU/mL
    -Proportion of subjects with an anti-HBs concentration ≥100 mIU/mL
    -Proportion of subjects with an anti-PRP concentration ≥0.15 μg/mL
    -Proportion of subjects with an anti-PRP concentration ≥1.0 μg/mL
    -Anti-PT and anti-FHA ≥ LLOQ, 2x LLOQ
    -Anti-PT and anti-FHA ≥ LLOQ, 2x LLOQ
    -Anti-D GMC
    -Anti-T GMC
    -Anti-IPV1 GMTs
    -Anti-IPV2 GMTs
    -Anti-IPV3 GMTs
    -Anti-HBs GMC
    -Anti-PRP GMC
    -Anti-PT GMCs
    -Anti-FHA GMCs
    E.5.2.1Timepoint(s) of evaluation of this end point
    PRIMARY SERIES:
    Immunogenicity:
    One month after dose 3 of Hexavalent vaccine

    Proportion of subjects with an anti-MenC titre ≥1:8 dil: one month after dose 1 of MenC vaccines

    Proportion of subjects with an anti-MenC titre ≥1:128 dil and Anti-MenC GMT: one month after dose 1 and one month after dose 2 of MenC vaccine.

    Safety:
    From Day 0 to Day 30 after each vaccination

    BOOSTER:
    Immunogenicity: Prior to administration of the hexavalent booster at 12 months of age

    Safety: From Day 0 to Day 30 after vaccination
    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 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 No
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned11
    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 No
    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
    The end of data collection including availability of final serology results
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 350
    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: 350
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Healthy infant 46 to 74 days of age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state350
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 350
    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)
    A plan for treatment or care after the subject has ended his/her participation in the trial is not provided for prophylactic vaccine studies as the subjects are healthy and do not need any treatment or care after the end of the study.
    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 Decision2013-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-11
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