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    Summary
    EudraCT Number:2011-004428-36
    Sponsor's Protocol Code Number:A3L27
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-04-10
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2011-004428-36
    A.3Full title of the trial
    Phase III, A3L24 extension protocol, randomized, blind-observer, multi-center booster vaccination study in toddlers who completed a three-dose primary series of DTaP-IPV-Hep B-PRP-T combined vaccine or of Infanrix hexa® (both concomitantly administered with Prevenar® (PCV7) and Rotarix®). All subjects will receive a booster dose of Prevenar (PCV7) concomitantly with the study vaccines.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Antibody Persistence Following a Primary Series at 2, 4, and 6 Months on Trial A3L24 and Booster Effect of the DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa® Concomitantly Administered with Prevenar® at 12 to 24 Months of Age in Healthy Latin American Infants
    A.4.1Sponsor's protocol code numberA3L27
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01444781
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1112-8473
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/015/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi Pasteur S.A
    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 S.A
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur S.A
    B.5.2Functional name of contact pointDirector, Clinical Development
    B.5.3 Address:
    B.5.3.1Street Address1541, Avenue Marcel Mérieux
    B.5.3.2Town/ cityMarcy l'Etoile
    B.5.3.3Post code69280
    B.5.3.4CountryFrance
    B.5.4Telephone number33(0)4 37 37 58 53
    B.5.5Fax number33(0)4 37 37 74 38
    B.5.6E-maileduardo.santos-lima@sanofipasteur.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 nameHexaxim
    D.3.2Product code DTaP-IPV-HepB-PRP-T vaccine
    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.3.9.2Current 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.3.9.2Current 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.3.9.2Current 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.3.9.2Current 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.3.9.2Current 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.3.9.2Current 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.3.9.2Current 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.3.9.2Current 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.3.9.2Current sponsor codePRP-T
    D.3.9.3Other descriptive nameHAEMOPHILUS TYPE B POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID
    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 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 Infanrix hexa
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    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.3.1Product nameInfanrix hexa
    D.3.4Pharmaceutical form Powder and suspension for 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.3.9.2Current 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 number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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.3.9.2Current 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.3.9.2Current 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.3.9.3Other descriptive namePERTUSSIS PERTACTIN
    D.3.9.4EV Substance CodeSUB20527
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current 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.3.9.2Current 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.3.9.2Current 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.3.9.2Current 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.3.9.2Current sponsor codePRP-T
    D.3.9.3Other descriptive nameHAEMOPHILUS TYPE B POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID
    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 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.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 infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus types 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virus
    E.1.1.1Medical condition in easily understood language
    Active immunisation against diphtheria,tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10021430
    E.1.2Term Immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10036897
    E.1.2Term Prophylactic vaccination
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10021431
    E.1.2Term Immunisations
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10043413
    E.1.2Term Therapeutic procedures and supportive care NEC
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Immunogenicity
    • To describe the antibody (Ab) persistence for all valences (except Prevenar [PCV7] and Rotarix), following a three-dose primary series vaccination, of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa at 2, 4 and 6 months of age
    • To describe the immunogenicity of a booster dose of DTaP-IPV-Hep B-PRP-T or Infanrix hexa given at 12 to 24 months concomitantly with a booster dose of Prevenar (PCV7)
    • To describe the immunogenicity of a booster dose of Prevenar (PCV7) given at 12 to 24 months in the same subset of subjects that participated in the Prevenar (PCV7) immunogenicity analysis in A3L24 Study (maximum of 544 subjects)

    Safety
    To describe the safety profile after a booster dose of DTaP-IPV-Hep B-PRP-T or Infanrix hexa given at 12 to 24 months of age concomitantly with a booster dose of Prevenar (PCV7)
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
    1) Aged 12 to 24 months on the day of inclusion
    2) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by independent witness(es) if required by local regulations)
    3) Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
    4) Toddlers previously included in Study A3L24 who completed the three-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa at 2, 4 and 6 months of age according to protocol (both concomitantly administered with Prevenar [PCV7] and Rotarix)
    E.4Principal exclusion criteria
    An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
    1) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the booster vaccinations
    2) Planned participation in another clinical trial during the present trial period
    3) Receipt of any vaccine in the 4 weeks preceding the booster vaccinations
    4) Planned receipt of any vaccine in the 4 weeks following the trial vaccinations
    5) Previous booster vaccination against pertussis, tetanus, diphtheria, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s) with either the trial vaccine or another vaccine
    6) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
    7) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
    8) Laboratory-confirmed or clinical suspicion of personal or maternal seropositivity for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C, as reported by the parent/guardian
    9) History of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s), confirmed either clinically, serologically, or microbiologically
    10) At high risk for opportunistic infection during the trial
    11) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
    12) History of contraindication to receipt of pertussis-containing vaccine:
    • Encephalopathy
    • Temperature > 40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series
    • Inconsolable crying that occurred for > 3 hours within 48 hours following vaccine injection during the primary series
    • Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series
    • Seizures with or without fever within 3 days following vaccine injection
    13) Laboratory-confirmed or clinical suspicion of thrombocytopenia contraindicating IM vaccination
    14) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
    15) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
    16) Receipt of oral or injected antibiotic therapy within 72 hours prior to the first blood draw
    17) Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity
    The following endpoints will be used to assess the Ab persistence (for all valences) before the booster doses at day 0 (D0) (Visit 1 [V01]) of DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa vaccine:
    • Ab titers for each valence
    • Ab titers above a pre-determined cut-off:
    • Anti-D Ab titers ≥ 0.01 IU/mL and ≥ 0.1 IU/mL
    • Anti-T Ab titers ≥ 0.01 IU/mL and ≥ 0.1 IU/mL
    • Anti-poliovirus 1, 2, and 3 titers ≥ 8 (1/dil)
    • Anti-Hep B Ab titers ≥ 10 mIU/mL and ≥ 100 mIU/mL
    • Anti-PRP Ab titers ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
    • Anti-PT and anti-FHA ≥ LLOQ
    The following endpoints will be used to assess the booster responses at D30 (V02):
    • Ab titers for each valence (including Prevenar [PCV7] vaccine)
    • Ab titers above a pre determined cut-off:
    • Anti-D Ab titers ≥ 0.01 IU/mL, ≥ 0.1 IU/mL, and ≥ 1.0 IU/mL
    • Anti-T Ab titers ≥ 0.01 IU/mL, ≥ 0.1 IU/mL, and ≥ 1.0 IU/mL
    • Anti-poliovirus 1, 2, and 3 titers ≥ 8 (1/dil)
    • Anti-Hep B Ab titers ≥ 10 mIU/mL and ≥ 100 mIU/mL
    • Anti-PRP Ab titers ≥ 0.15 μg/mL and ≥ 1.0 μg/mL
    • Anti-pneumococcal serotype 4, 6B, 9V, 14, 18C, 19F, and 23F titers
    ≥ 0.35 μg/mL (in a subset of subjects only, maximum of 544 subjects)
    • Individual titer ratio for each valence (V02/V01), except for Prevenar (PCV7)
    • Seroconversion for pertussis Ab (anti-acellular pertussis toxoid [anti-PT] and anti-filamentous hemagglutinin [anti-FHA]) defined as:
    • Anti-PT and anti-FHA ≥ 4-fold Ab titers increase from V01 to V02
    • Booster response to pertussis antigens (PT and FHA) defined as:
    • Subjects whose pre-vaccination Ab concentrations are less than the Lower Limit Of Quantitation (< LLOQ), will demonstrate the booster response if they have post-vaccination levels ≥ 4 x LLOQ
    • Subjects whose pre-vaccination Ab concentrations are ≥ LLOQ but < 4 x LLOQ, will demonstrate the booster response if they have a 4-fold response (i.e. post-/pre-vaccination ≥ 4)
    • Subjects whose pre-vaccination Ab concentrations are ≥ 4 x LLOQ, will demonstrate the booster response if they have a 2-fold response (i.e., post-/pre-vaccination ≥ 2)

    Safety
    • Occurrence, nature (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), duration, intensity, and relationship to vaccination for any unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
    • Occurrence, time to onset, number of days of occurrence, and severity for solicited (prelisted in the subject diary and case report form [eCRF]) injection site and systemic reactions occurring up to 7 days after each vaccination
    • Occurrence, nature (MedDRA preferred term), time to onset, duration, severity, and relationship to vaccination (for systemic adverse events only) of unsolicited (spontaneously reported) adverse events up to 30 days after each vaccination
    • Occurrence of SAEs throughout the trial (including the 6-month follow up period)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood sampling
    All subjects will provide a pre-vaccination blood sample of approximately 5 mL at D0 (V01) and a post-vaccination sample of approximately 5 mL at D30 (V02).

    Collection of safety data
    Subjects will record information in terms of immediate reactions within 30 minutes after booster vaccination, solicited reactions within 7 days and unsolicited adverse events within 30 days after booster vaccination, and SAEs will be collected throughout the trial period (within 180 days after the booster vaccination). Related SAE which occur between the primary series and the booster phase should be reported.
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy 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 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
    blind observer
    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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Colombia
    Costa Rica
    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
    end of the trial = LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 1376
    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: 1376
    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
    Vulnerable pop (enfants): ICF signed by the subject's the parent(s)/legal representative (and by an independent witness if required by local regulations)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1376
    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)
    Not applicable
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Colombia
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