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    Summary
    EudraCT Number:2021-004053-23
    Sponsor's Protocol Code Number:V419-016
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-12-16
    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 ConcernedGermany - PEI
    A.2EudraCT number2021-004053-23
    A.3Full title of the trial
    A Phase 4, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Vaxelis™ in Healthy Children Previously Vaccinated With a 2-Dose Primary Infant Series of Either Vaxelis™ or Hexyon™
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, Tolerability, and Immunogenicity of Vaxelis™ after an Infant Series of either Vaxelis™ or Hexyon™.
    A.4.1Sponsor's protocol code numberV419-016
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme LLC
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme LLC
    B.5.2Functional name of contact pointAndrea Guerra
    B.5.3 Address:
    B.5.3.1Street Address126 East Lincoln Ave., P.O. Box 2000
    B.5.3.2Town/ cityRahway, NJ
    B.5.3.3Post code07065
    B.5.3.4CountryUnited States
    B.5.4Telephone number+447971655073
    B.5.6E-mailandrea.guerra@msd.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 Vaxelis®
    D.2.1.1.2Name of the Marketing Authorisation holderMCM Vaccine B.V.
    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 in pre-filled syringe
    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, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT), HEPATITIS B (RDNA), POLIOMYELITIS (INACT.) AND HAEMOPHILUS TYPE B CONJUGATE VACCINE (ADSORBED)
    D.3.9.2Current sponsor codeV419
    D.3.9.3Other descriptive nameDIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT), HEPATITIS B (RDNA), POLIOMYELITIS (INACT.) AND HAEMOPHILUS TYPE B CONJUGATE VACCINE (ADSORBED)
    D.3.9.4EV Substance CodeSUB25314
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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.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
    Vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive diseases caused by Haemophilus influenzae type b
    E.1.1.1Medical condition in easily understood language
    Vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive diseases 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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10036897
    E.1.2Term Prophylactic vaccination
    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
    1. To evaluate the safety and tolerability of a booster dose of Vaxelis™ with respect to the proportion of participants with adverse events (AEs).
    2. To describe the response rates to antigens contained in both Vaxelis™ and Hexyon™ 30 days after a booster dose of Vaxelis™.
    E.2.2Secondary objectives of the trial
    1. To describe the response rates to the pertussis antigens contained in Vaxelis™, but not in Hexyon™, 30 days after a booster dose of Vaxelis™.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Is healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator.
    2. Has received a 2-dose infant primary series of either Vaxelis™ or Hexyon™ at approximately 2 and 4 months of age (based on a review of medical history), respectively.
    3. Is male or female, from approximately 11 months to 13 months of age (≥327 days to ≤396 days) inclusive, at the time of obtaining the informed consent.
    4. A legally acceptable representative has provided documented informed consent for the study.
    E.4Principal exclusion criteria
    1. Has a known or suspected impairment of immunological function.
    2. Has known or history of functional or anatomic asplenia.
    3. Has a known hypersensitivity to any component of the study vaccine.
    4. Has a known or suspected blood dyscrasia, leukemia, lymphoma of any type or other malignant neoplasm affecting the hematopoietic and lymphatic system.
    5. Has a bleeding disorder contraindicating intramuscular vaccination.
    6. Has a history of Hib, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus infection.
    7. Was born to a mother with a known history of hepatitis B infection.
    8. *Had a recent febrile illness (defined as rectal temperature ≥38.1°C [≥100.5°F] or axillary temperature ≥37.8°C [≥100.0°F]) occurring at or within 72 hours prior to receipt of study vaccine.
    9. Has encephalopathy of unknown etiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine.
    10. Has an uncontrolled neurologic disorder or uncontrolled epilepsy.
    11. Has a health or developmental disorder that, based on the clinical judgment of the investigator, could affect evaluation of the vaccine.
    12. Has received or is expected to receive immunosuppressive agents during the conduct of the study.
    13. *Meets 1 or more of the following systemic corticosteroid exclusion criteria:
    a. Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/d for persons weighing >10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days before study entry.
    b. Has received any systemic corticosteroids within 14 days before study vaccination.
    c. Is expected to require any systemic corticosteroids during conduct of the study.
    14. *Has received any licensed, non-live vaccine within the 14 days before receipt of study vaccine or is scheduled to receive any licensed, non-live vaccine prior to Visit 2 blood draw.
    Exception: Participant may receive nonstudy pediatric licensed non-live vaccines on same day as study vaccine is given (Day 1).
    Exception: Non-live influenza vaccine may be administered, but must be given at least 7 days before receipt of study vaccine or at least 15 days after receipt of study vaccine.
    15. *Has received any licensed live vaccine within 30 days before receipt of study vaccine or is scheduled to receive any live vaccine prior to Visit 2 blood draw.
    16. *Has received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.
    17. *Has participated in another clinical study of an investigational product within 2 months before study vaccination at Visit 1 (Day 1) or plans to participate anytime during the duration of the current clinical study. Participants previously or currently enrolled in a COVID-19 vaccine clinical study, or enrolled in observational studies may be included; these should be reviewed on a case-by-case basis for approval by the Sponsor.
    18. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.

    For items with an asterisk (*), if the participant meets these exclusion criteria, Visit 1 may be rescheduled for a time when these criteria are not met.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of participants with solicited injection-site AEs from Day 1 through Day 5 postvaccination
    2. Percentage of participants with solicited systemic AEs from Day 1 through Day 5 postvaccination
    3. Percentage of subjects with unsolicited AEs from Day 1 to Day 15 postvaccination
    4. Percentage of participants with serious adverse events (SAEs) through completion of study participation
    5. Percentage of participants with diphtheria toxoid ≥0.1 IU/mL
    6. Percentage of participants with tetanus toxoid ≥0.1 IU/mL
    7. Percentage of participants with pertussis toxoid (PT) vaccine response
    8. Percentage of participants with filamentous hemagglutinin (FHA) vaccine response
    9. Percentage of participants with Haemophilus influenzae type b polyribosylribitol phosphate (Hib-PRP) ≥1.0 µg/mL
    10. Percentage of participants with hepatitis B surface antigen (HbSAg) ≥10 mIU/mL
    11. Percentage of participants with poliovirus serotype 1 ≥1:8 dilution
    12. Percentage of participants with poliovirus serotype 2 ≥1:8 dilution
    13. Percentage of participants with poliovirus serotype 3 ≥1:8 dilution
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to 5 days
    2. Up to 5 days
    3. Up to 15 days
    4. Up to 40 days
    5. 30 days postvaccination
    6. 30 days postvaccination
    7. 30 days postvaccination
    8. 30 days postvaccination
    9. 30 days postvaccination
    10. 30 days postvaccination
    11. 30 days postvaccination
    12. 30 days postvaccination
    13. 30 days postvaccination
    E.5.2Secondary end point(s)
    1. Percentage of participants with pertactin (PRN) vaccine response
    2. Percentage of participants with fimbriae 2/3 (FIM 2/3) vaccine response
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 30 days postvaccination
    2. 30 days postvaccination
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.3 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 160
    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: 160
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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 Decision2021-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-30
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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