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    Summary
    EudraCT Number:2015-005337-45
    Sponsor's Protocol Code Number:PNA19
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-12-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-005337-45
    A.3Full title of the trial
    Immunogenicity and Safety of a Booster Dose of Polysaccharide Pneumococcal vaccine (Pneumo 23®) in 12 to 18 Months-Old Children Primed with Three Doses of Pneumococcal Conjugate Vaccine (Prevnar®) in Thailand
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety of a Booster Dose of Pneumo 23® in 12 to 18 Months-Old Children Primed With Prevnar
    A.4.1Sponsor's protocol code numberPNA19
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00594347
    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 SA
    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 SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI PASTEUR SA
    B.5.2Functional name of contact pointMedical Team Leader
    B.5.3 Address:
    B.5.3.1Street Address1 Discovery Drive
    B.5.3.2Town/ citySWIFTWATER, PA
    B.5.3.3Post code18370
    B.5.3.4CountryUnited States
    B.5.6E-mailRegistryContactUs@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 Yes
    D.2.1.1.1Trade name Pneumo 23®
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PASTEUR SA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.11 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 PREVENAR
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER LTD
    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 namePrevnar®
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy volunteers: prevention of invasive disease caused by S pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F and prevention of otitis media caused by S pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F

    E.1.1.1Medical condition in easily understood language
    Protection against S pneumoniae
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Immunogenicity
    - To assess and describe the immunogenicity for 12 serotypes of the study
    vaccines one month after the booster vaccination in both groups
    Safety
    - To describe the safety of the study vaccines after the booster vaccination
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 12 to 18 months on the day of inclusion
    2. Informed consent form signed by the parent/legally acceptable representative and
    by an independent witness if requested by local Ethics Committee regulation
    or/and if the parent/legally acceptable representative is illiterate
    3. Child having completed the three-dose primary vaccination of Prevnar® in the
    hexavalent combined vaccine study (study A3L12)
    4. Subjects and parent/guardian able to attend all scheduled visits and comply with
    all study procedures
    E.4Principal exclusion criteria
    1. Participation in another clinical study investigating a vaccine, drug, medical
    device, or a medical procedure in the 4 weeks preceding the study vaccination
    2. Planned participation in another clinical study during the present study period
    3. Known or suspected congenital or acquired immunodeficiency
    immunosuppressive therapy such as long-term systemic corticosteroids therapy
    4. Known systemic hypersensitivity to any of the vaccine components or history of a
    life-threatening reaction to the study vaccine or to a vaccine containing any of the
    same substances
    5. Chronic illness at a stage that could interfere with study conduct or completion, in
    the opinion of the investigator
    6. Receipt of blood or blood-derived products since birth that might interfere with
    the assessment of immune response
    7. Receipt of any vaccine in the 4 weeks preceding the first study vaccination
    8. Planned receipt of any vaccine in the 4 weeks preceding or following study
    vaccination
    9. History of seizures
    10. Known personal Human Immunodeficiency Virus (HIV), Hepatitis B (HB)
    antigen or Hepatitis C seropositivity
    11. History of pneumococcal infection (confirmed either clinically, serologically or
    microbiologically)
    12. Previous booster vaccination against the pneumococcal disease with either the
    study vaccine(s) or another vaccine
    13. Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding
    inclusion contraindicating IM vaccination
    14. Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection
    on the day of vaccination, according to investigator judgment
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity
    30 Days after the booster vaccination in both groups (at V02/D30):
    - Individual antibody (Ab) titers of the following serotypes 1, 3, 4, 5, 6B, 7F,
    9V, 14, 18C, 19A, 19F, 23F (measured by ELISA)
    - For each serotype
    o Individual antibody titer ratio*
    o Individual antibody titers ≥ 0.15 μg/mL, ≥ 0.35 μg/mL, ≥ 0.5 μg/mL,
    and ≥ 1 μg/mL
    * Individual titer ratio: post-booster vaccination / pre-booster vaccination
    Safety:
    • Occurrence, nature (Medical Dictionary for Regulatory Activities (MedDRA)
    preferred term), time to onset, duration, intensity, relationship to vaccination to
    any unsolicited systemic adverse events (AEs) reported in the 30 minutes after
    vaccination
    • Occurrence, time to onset, number of days of occurrence and intensity of solicited
    (prelisted in the subject diary and Case Report Form [CRF]) injection site and
    systemic reactions within 7 days after vaccination.
    • Occurrence, nature (MedDRA preferred term), time to onset, duration, intensity,
    and relationship to vaccination (for systemic adverse events only) of unsolicited
    (spontaneously reported) adverse events from vaccination day to next study visit
    (30 Days)
    • Occurrence, nature (MedDRA preferred term), time to onset, duration,
    relationship to vaccination, outcome, seriousness criteria of serious adverse events
    occurring throughout the study
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects will be kept under observation for 30 minutes after vaccination to ensure their safety.
    After vaccination, subject’s/parents or guardians will record the following information about any AEs in a safety diary card:
    - Solicited reactions will be collected from Day 0 to Day 7 after each injection.
    - Unsollicicited AEs will be collected rom Day 0 to Day 30 after each injection
    Blood samples of 5 mL each will be taken for antibodies titration:
    - Before administration of the booster (BL01-V01),
    - One month after administration of the booster (BL02-V02),
    The antibody concentrations for the twelve serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the OPA assays for the five serotypes (1, 6B, 14, 19A, 23F) will be measured at the Laboratory.
    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 No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 trial2
    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
    Thailand
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months6
    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: 408
    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: 408
    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
    The investigator ask one of the subject’s parent(s)/guardian(s) and one witness (if necessary) to sign and date the ICF.
    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 448
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Thailand
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