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    Summary
    EudraCT Number:2021-005427-20
    Sponsor's Protocol Code Number:C4601003
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-04-26
    Trial 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 number2021-005427-20
    A.3Full title of the trial
    A PHASE 3, MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, IMMUNOGENICITY, AND LOT CONSISTENCY OF A 6 VALENT OspA-BASED LYME DISEASE VACCINE IN HEALTHY PARTICIPANTS ≥5 YEARS OF AGE
    Wieloośrodkowe, randomizowane, zaślepione dla obserwatora badanie fazy III z grupą kontrolną otrzymującą placebo, mające na celu ocenę skuteczności, bezpieczeństwa, tolerancji, immunogenności i spójności serii 6-walentnej szczepionki przeciwko boreliozie opartej na białku OspA u zdrowych uczestników w wieku ≥5 lat
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3, Placebo-Controlled, Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Trial of a 6-Valent OspA-Based Lyme Disease Vaccine
    A.4.1Sponsor's protocol code numberC4601003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05477524
    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 SponsorPfizer Inc.
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address66 Hudson Boulevard East
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10001
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 namePF-07307405 (180μg/dose)
    D.3.2Product code VLA15
    D.3.4Pharmaceutical form Suspension 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 INNLip-D1B2B
    D.3.9.2Current sponsor codeLip-D1B2B
    D.3.9.3Other descriptive nameBorrelia burgdorferi, serotype 1, Outer surface protein A fused via a linker to Borrelia burgdorferi, serotype 2, Outer Surface Protein A
    D.3.9.4EV Substance CodeSUB224175
    D.3.10 Strength
    D.3.10.1Concentration unit µl/ml microlitre(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLip-D4Bva3B
    D.3.9.2Current sponsor codeLip-D4Bva3B
    D.3.9.3Other descriptive nameBorrelia burgdorferi, serotype 3, Outer surface protein A fused via a linker to Borrelia burgdorferi, serotype 4, Outer surface protein A
    D.3.9.4EV Substance CodeSUB224176
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLip-D5B6B
    D.3.9.2Current sponsor codeLip-D5B6B
    D.3.9.3Other descriptive nameBorrelia burgdorferi, serotype 5, Outer surface protein A fused via a linker to Borrelia burgdorferi, serotype 6, Outer surface protein A
    D.3.9.4EV Substance CodeSUB224177
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    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
    Prevention of Lyme disease caused by Borrelia species in individuals ≥5 years of age by active immunization
    E.1.1.1Medical condition in easily understood language
    Prevention of Lyme disease
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10025169
    E.1.2Term Lyme disease
    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
    Primary Efficacy
    1. To demonstrate the efficacy of VLA15 in preventing confirmed Lyme disease in the Lyme disease season after completion of the primary series vaccination and booster dose.
    Primary Safety
    1.To describe the safety profile of VLA15 as measured by the percentage of participants reporting local reactions, systemic events, AEs, NDCMCs, and SAEs.
    Primary Immunogenicity
    1.To demonstrate that the immune responses to the 6 serotypes induced by VLA15 are equivalent across 3 independent lots.
    2.To demonstrate that the immune responses to the 6 serotypes induced by VLA15 in children 5 through 17 years of age are noninferior to those in adults 18 through 44 years of age after the booster dose.
    E.2.2Secondary objectives of the trial
    Secondary Efficacy
    1. To demonstrate the efficacy of VLA15 in preventing confirmed Lyme disease in the Lyme disease season after completion of the primary series vaccination and booster dose in NA.
    2. To demonstrate the efficacy of VLA15 in preventing confirmed Lyme disease in the Lyme disease season after completion of the primary series vaccination.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    Age and Sex:
    1.Male or female participants ≥5 years of age at enrollment (signing of ICD or assent) in all countries where pediatric enrollment is permitted. In countries or sites where enrollment of children is not permitted, male or female participants ≥18 years of age at the time of informed consent.
    • Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.

    Type of Participant and Disease Characteristics:
    2.Participants who reside in areas with endemic Lyme disease and who lead lifestyles that put them at increased risk for Lyme disease. For example, this could include, but not be limited to:
    •Individuals who work in B burgdorferi–infected/tick-infested areas, especially those with occupations that may be associated with higher risk of exposure, such as landscaping, forestry, and wildlife and parks management.
    •Individuals who pursue recreational activities such as hiking, camping, fishing, hunting, jogging, or gardening in such areas.
    •Individuals who live on land plots with tree lines and come into contact with these trees regularly.
    •Individuals who have dogs that regularly are outdoors and frequently return with attached ticks.
    •Individuals who participate in activities in areas with tall grass, smaller wooded areas beside forests, open fields, lakesides, and riversides.
    •Any other risk factors determined at the discretion of the investigators.
    3.Participants or participants’ parent(s)/legal guardian(s), as age appropriate, who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures; are expected to be available for the duration of the study; and can be contacted by telephone during study participation.
    4.Healthy male and female participants at enrollment who are determined by medical history, PE, and clinical judgment of the investigator to be eligible for inclusion in the study. Participants with preexisting chronic medical conditions determined to be stable may be included.
    Informed Consent and Assent (as Appropriate):
    5.Capable of giving signed informed consent, and assent (as appropriate), as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. The investigator, or a person designated by the investigator, will obtain informed consent (and assent, as appropriate) from each study participant or study participant’s parent(s)/legal guardian (as defined in Appendix 1) before any study-specific activity is performed. All parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. The investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    1.Pregnant female participants; breastfeeding female participants; positive urine pregnancy test for female participants at Visit 1 (prior to vaccination); WOCBP who are, in the opinion of the investigator, sexually active and at risk for pregnancy; and fertile men and WOCBP who are unwilling or unable to use effective methods of contraception as outlined in this protocol from the signing of the informed consent through 28 days after completion of the primary vaccination series and from the booster dose through 28 days after the booster vaccination.
    Medical Conditions:
    2.Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
    3.Any diagnosis of Lyme disease within the past 3 months.
    4.Any history of Lyme carditis, neuroborreliosis, arthritis, or other disseminated Lyme disease regardless of when diagnosed.
    5.Known tick bite within the past 4 weeks.
    6.Newly developed or unstable underlying conditions that may interfere with the assessment of Lyme disease, including but not limited to chronic arthralgia/arthritis, second/third-degree AV heart block, chronic pain syndromes, and chronic skin conditions that reduce the ability to detect cutaneous manifestations of Lyme disease.
    7.Underlying clotting deficiency (eg, bleeding disorder, thrombocytopenia) that may increase the risk of excessive bleeding following required study procedures.
    8.Congenital or acquired immunodeficiency or treatments that would inhibit the ability to mount an immune response to a vaccine.
    9.Any unstable autoimmune condition with a manifestation (eg, arthritic and neurologic) that may interfere with the assessment of Lyme disease. (Potential participants with well-controlled, stable autoimmune conditions under the care of a rheumatologist are eligible).
    10.Underlying bone marrow disorder such as myelodysplasia, myeloma, or myeloproliferative disorder, treated within the past year, or any history of bone marrow transplant.
    11.Malignancy that required treatment with chemotherapy (including the use of adjunctive and hormonal therapy), immunotherapy, radiation therapy, or antineoplastic target therapies within the past 24 months.
    12.Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
    Prior/Concomitant Therapy:
    13.Receipt of a previous vaccination for Lyme disease.
    Note: This includes Lyme vaccine clinical trials where study intervention was received or is unknown.
    14.treatment for Lyme disease in the 3 months prior to study intervention administration.
    15.Chronic systemic doxycycline or minocycline or other tetracycline class drug use for acne or any other chronic suppressive antibiotics used to treat other conditions.
    16.Receipt of blood/plasma products or immunoglobulins within 6 months before study intervention administration through conclusion of the study.
    17.Receipt of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for ≥14 days within 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
    18.Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months before study intervention administration.
    19.Receipt of anticoagulant therapy within 1 month before study intervention administration. Monotherapy with aspirin or standard-dose anti-platelet medications (eg, clopidogrel, ticagrelor, prasugrel, dipyridamole, ticlopidine, eptifibatide) is permitted.
    Prior/Concurrent Clinical Study Experience:
    20.Participation in other studies involving investigational drug(s), investigational vaccines, or investigational devices within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable.
    Diagnostic Assessments:
    Not applicable.
    Other Exclusions:
    21.Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy
    1. Clinically- and laboratory confirmed Lyme disease caused by B burgdorferi sensu lato (as determined by the AC)
    Primary Safety
    1.
    •Local reactions (pain at the injection site, redness, and swelling).
    •Systemic events (fever, headache, fatigue, muscle pain, and joint pain).
    •AEs.
    •NDCMCs.
    •SAEs.
    Primary Immunogenicity
    1. Anti-OspA quantitative immunological assay titer.
    2. Anti-OspA quantitative immunological assay titer.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoints described in detail in the Protocol
    E.5.2Secondary end point(s)
    Secondary Efficacy
    1.Clinically- and laboratory-confirmed Lyme disease caused by B burgdorferi sensu lato. (as determined by the AC)
    2.Clinically- and laboratory-confirmed Lyme disease caused by B burgdorferi sensu lato. (as determined by the AC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints described in detail in the Protocol
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, Tolerability
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 Yes
    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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Canada
    United States
    Finland
    Germany
    Netherlands
    Poland
    Sweden
    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 visit of the last subject
    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 months4
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days26
    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: 700
    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) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 350
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 350
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6550
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2150
    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 Yes
    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
    Children cannot gives consent on their own
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1800
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3000
    F.4.2.2In the whole clinical trial 9400
    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)
    No intervention will be provided to study participants at the end of the
    their study participation
    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 Decision2022-06-24
    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 StatusTrial now transitioned
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