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    Summary
    EudraCT Number:2016-000117-76
    Sponsor's Protocol Code Number:204838
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-06-06
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-000117-76
    A.3Full title of the trial
    A Phase 1/2, randomized, observer-blind, controlled, multi-center, dose-escalation study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals’ respiratory syncytial virus (RSV) investigational vaccine based on the RSV viral proteins F, N and M2-1 encoded by chimpanzee-derived adenovector (ChAd155-RSV) (GSK3389245A), when administered intramuscularly according to a 0, 1-month schedule to RSV-seropositive infants aged 12 to 23 months.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate safety and immunogenicity of GSK Biologicals’ RSV investigational vaccine in RSV-seropositive infants aged 12 to 23 months.
    A.3.2Name or abbreviated title of the trial where available
    RSV PED-002
    A.4.1Sponsor's protocol code number204838
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Biologicals
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de l'Institut, 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number442089904466
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 nameChAd155-RSV (high dose)
    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 INN-
    D.3.9.2Current sponsor codeChAd155-RSV
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50000000000
    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 Yes
    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 nameChAd155-RSV (low dose)
    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 INN-
    D.3.9.2Current sponsor codeChAd155-RSV
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5000000000
    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 Yes
    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 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 nameChAd155-RSV (middle dose)
    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 INN-
    D.3.9.2Current sponsor codeChAd155-RSV
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15000000000
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active immunization of infants for the prevention of any lower respiratory tract infections (LRTI; bronchiolitis and [broncho]pneumonia) associated with respiratory syncytial virus (RSV [subtypes A and B])
    E.1.1.1Medical condition in easily understood language
    Respiratory tract infection caused by respiratory syncytial virus (RSV)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10038718
    E.1.2Term Respiratory syncytial virus bronchiolitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10035692
    E.1.2Term Pneumonia due to respiratory syncytial virus
    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
    To evaluate the safety and reactogenicity of three dose levels of the RSV investigational vaccine when administered as two IM doses according to a 0, 1-month schedule, up to 30 days after Dose 2 (i.e. Day 60) in RSV-seropositive infants aged 12 to 23 months.
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety of two IM doses of three dose levels of the RSV investigational vaccine when administered according to a 0, 1-month schedule from study start (Day 0) up to study conclusion (Day 730) in RSV-seropositive infants aged 12 to 23 months.
    2. To evaluate the occurrence of RSV respiratory tract infections in RSV-seropositive infants from Visit 1 (Day 0, after Dose 1) up to study conclusion (Day 730).
    3. To evaluate the magnitude of the cell-mediated immunity (CMI) induced by two IM doses of three dose levels of the RSV investigational vaccine when administered according to a 0, 1-month schedule, up to Day 365 in RSV-seropositive infants aged 12 to 23 months.
    4. To evaluate the humoral immunogenicity induced by two IM doses of three dose levels of the RSV investigational vaccine when administered according to a 0, 1-month schedule, up to Day 365 in RSV-seropositive infants aged 12 to 23 months.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects’ parent(s)/ Legally acceptable representative (LAR[s]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
    2. Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
    3. A male or female between, and including, 12 and 23 months at the time of the first vaccination.
    4. Healthy subjects as established by medical history and clinical examination before entering into the study.
    5. Seropositive for RSV as determined by IBL International kit.
    6. Born full-term (i.e. after a gestation period of 37 to less than 42 completed weeks) with a minimum birth weight of 2.5 kg. (Required for Spain)
    7. Subjects’ parent(s)/LAR(s) need to have access to a consistent mean of telephone contact or computer.
    E.4Principal exclusion criteria
    1. Child in care
    2. Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 0), or planned use during the study period.
    3. Any medical condition that in the judgment of the investigator would make IM injection unsafe.
    4. Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine. For corticosteroids, this will mean prednisone, or equivalent. Inhaled and topical steroids are allowed.
    5. Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
    6. Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period.
    7. Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of scheduled routine pediatric vaccines which may be administered >= 14 days before a dose or >= 7 days after a dose.
    8. Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
    9. Serious chronic illness.
    10. Major congenital defects.
    11. History of any neurological disorders or seizures.
    12. History of or current autoimmune disease.
    13. History of recurrent wheezing.
    14. History of chronic cough.
    15. Previous hospitalization for respiratory illnesses.
    16. History of thrombocytopenia.
    17. History of anemia.
    18. Previous, current or planned administration of Synagis.
    19. Neurological complications following any prior vaccination.
    20. Born to a mother known or suspected to be HIV-positive.
    21. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
    22. Family history of congenital or hereditary immunodeficiency.
    23. Previous vaccination with a recombinant simian or human adenoviral vaccine.
    24. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
    25. Hypersensitivity to latex.
    26. Current severe eczema.
    27. Acute disease and/or fever at the time of enrolment.
    - Fever is defined as temperature ≥ 37.5°C/99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route. The preferred route for recording temperature in this study will be axillary.
    - Clinically significant upper respiratory tract infection
    - Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
    28. Any clinically significant Grade 1 or any ≥ Grade 2 hema-tological or biochemical laboratory abnormality detected at the last screening blood sampling.
    29. Any other conditions that the investigator judges may interfere with study procedures or findings.
    30. Any conditions that could constitute a risk for the subjects while participating to this study.
    31. Weight below the fifth percentile of the local weight-for-age curve.
    32. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
    33. Planned move to a location that will prohibit participating in the trial until study end.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of AEs from first vaccination (Day 0) up to Day 60.
    -Occurrence of each solicited local and general AE, during a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days).
    -Occurrence of any unsolicited AE, during a 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days).
    -Occurrence of any SAE from Day 0 up to Day 60.
    -Occurrence of episode of spontaneous or excessive bleeding (AE of specific interest), during a 30-day follow-up period after each vaccination.
    -Occurrence of any hematological (hemoglobin level, white blood cells and platelets) laboratory abnormalities at Screening, Day 1, Day 7, Day 30, Day 31, Day 37, and Day 60.
    -Occurrence of any biochemical (alanine aminotransferase, aspartate aminotransferase and creatinine) laboratory abnormalities at Screening, Day 30, and Day 60.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days).
    2. During a 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days).
    3. From Day 0 up to Day 60.
    4. During a 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days).
    5. At Screening (Day 0), Day 1, Day 7, Day 30, Day 31, Day 37, and Day 60.
    6. At Screening (Day 0), Day 30, and Day 60.
    E.5.2Secondary end point(s)
    -Occurrence of SAEs from study start (Day 0) up to study conclusion (Day 730).
    - Occurrence of RSV-LRTI (AE of specific interest) as from Dose 1 administration up to study conclusion (Day 730).
    -Occurrence of RSV-RTI, RSV-LRTI, severe RSV-LRTI (according to standardized case definitions) as from Dose 1 administration up to study conclusion (Day 730).
    -Magnitude of the CMI response to the investigational RSV vaccine, pre-vaccination (Screening), post-Dose 1 (Day 30) and post-Dose 2 (Day 60 and Day 365).
    - CD3+/CD4+ T-cells expressing at least two markers among CD40L, IL-2, TNF-α, and IFN-γ upon stimulation with F, N and M2-1 peptide pools.
    - Humoral response to the investigational RSV vaccine, pre-vaccination (Screening),post-Dose 1 (Day 30) and post-Dose 2 (Day 60 and Day 365):
    - Neutralizing antibody titers against RSV-A.
    - RSV F antibody concentrations.
    - Humoral response to the investigational RSV vaccine, pre-vaccination (Screening), post-Dose 1 (Day 30) and post-Dose 2 (Day 60):
    - Palivizumab-competing antibody concentrations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From study start (Day 0) up to study conclusion (Day 730).
    2. From Dose 1 administration (Day 0) up to study conclusion (Day 730).
    3. From Dose 1 administration (Day 0) up to study conclusion (Day 730).
    4. Pre-vaccination (Screening), post-Dose 1 (Day 30) and post-Dose 2 (Day 60 and Day 365).
    5. Pre-vaccination (Screening), post-Dose 1 (Day 30) and post-Dose 2 (Day 60 and Day 365).
    6. Pre-vaccination (Screening), post-Dose 1 (Day 30) and post-Dose 2 (Day 60).
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    First administration to infants following a first study in human performed on adults.
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    observer-blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Australia
    Canada
    Hong Kong
    Italy
    Mexico
    Panama
    Poland
    Russian Federation
    Spain
    Taiwan
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last testing results released of samples collected at Day 730.
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days6
    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: 96
    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: 96
    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
    infants aged 12 to 23 months
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 96
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-08-29
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-03-31
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