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    Summary
    EudraCT Number:2025-000381-28
    Sponsor's Protocol Code Number:VLA15-221
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2026-02-02
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2025-000381-28
    A.3Full title of the trial
    SAFETY AND IMMUNOGENICITY STUDY OF VLA15, A MULTIVALENT RECOMBINANT OSPA BASED VACCINE CANDIDATE AGAINST LYME BORRELIOSIS: A RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE 2 STUDY IN A HEALTHY PEDIATRIC AND ADULT STUDY POPULATION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 study to assess the safety and immune responses of VLA15-221, A Vaccine Candidate Against Lyme Borreliosis, In a Healthy Pediatric and Adult Population
    A.4.1Sponsor's protocol code numberVLA15-221
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04801420
    A.5.4Other Identifiers
    Name:Pfizer Alias IDNumber:C4601008
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/080/2024
    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.4.1Name of organisation providing supportValneva Austria GmbH
    B.4.2CountryAustria
    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 Center
    B.5.3 Address:
    B.5.3.1Street Address66 Hudson Blvd.
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10001
    B.5.3.4CountryUnited States
    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
    D.3.2Product code VLA15
    D.3.4Pharmaceutical form Injection
    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.3.9.3Other descriptive nameBorrelia burgdorferi, serotype 1, outer surface protein A fused via a linker to Borrelia afzelii, serotype 2, outer surface protein A
    D.3.9.4EV Substance CodeSUB224175
    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-D4Bva3B
    D.3.9.3Other descriptive nameBorrelia garinii, serotype 3, outer surface protein A fused via a linker to Borrelia bavariensis, 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.3.9.3Other descriptive nameBorrelia garinii, serotype 5, outer surface protein A fused via a linker to Borrelia garinii, 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    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
    Lyme borreliosis
    E.1.1.1Medical condition in easily understood language
    Lyme Disease
    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
    Safety:
    • To assess the safety and tolerability profile of VLA15, given in a three- or two dose primary immunization schedule (Month 0-2-6 or Month 0-6), in a healthy study population aged 5 to 65 years up to Day 208 (Month 7).
    Immunogenicity:
    • To assess the immune response to VLA15, given in a three- or two dose primary immunization schedule (Month 0-2-6 or Month 0-6), in a healthy study population aged 5 to 65 years at Day 208 (Month 7).
    E.2.2Secondary objectives of the trial
    Safety:
    • To assess the safety and tolerability profile of VLA15, given in a three- or two dose primary immunization schedule (Month 0-2-6 or Month 0-6), in a healthy study population aged 5 to 65 years, up to one year after the last primary vaccination (Month 18).
    • To assess the safety and tolerability profile of VLA15 booster vaccinations (i.e., Booster 1 at Month 18, one year after completion of the primary vaccination schedule, Booster 2 at Month 30 and Booster 3 at Month 42) until study end.
    Immunogenicity:
    • To assess the immune response to VLA15, applied in a three- or two dose primary immunization schedule (Month 0-2-6 or Month 0-6), in a healthy study population aged 5 to 65 years, up to one year after the last primary vaccination (Month 18).
    • To assess the immune response of VLA15 booster vaccinations (i.e., Booster 1 at Month 18, one year after completion of the primary vaccination schedule, Booster 2 at Month 30 and Booster 3 at Month 42) until study end.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject is aged 5 to 65 years at the day of screening (Visit 0)
    Subject is of good general health
    Parent(s)/legal representative(s) and subject understand the study and its procedures, agree to its provisions

    for subjects aged 18-65 years: written informed consent prior to any study related procedures
    for subjects aged 5-17 years: written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable, prior to any study related procedures.
    If subject is of childbearing potential: Subject has a negative serum pregnancy test at screening (Visit 0) and agrees to employ adequate birth control measures according to following timelines:

    Main Study Phase: duration of entire study
    Booster Phase: until 5 months after each booster vaccination (Booster 1 until Month 23, Booster 2 until Month 35 and Booster 3 until Month 47)
    Subject is willing and able to comply with scheduled visits, treatment plan, and other study procedures
    Subject is available for the duration of the study and can be contacted by telephone during study participation
    E.4Principal exclusion criteria
    Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB, or received treatment for LB within the last 3 months prior to Day 1;
    Subject received previous vaccination against LB;
    Subject had a tick bite within 4 weeks prior to Day 1;
    Subject has a medical history of or currently has a clinically relevant disease;
    Subject has a medical history of or currently has a neuro- inflammatory or autoimmune disease;
    Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the 3 weeks prior to Day 1;
    Subject has received an active or passive immunization within 4 weeks prior to Day 1;
    Subject has received any other registered or non-registered medicinal product in another clinical trial within 4 weeks prior to vaccination at Day 1;
    Subject has a known or suspected defect of the immune system or received immuno-suppressive therapy within 4 weeks prior to Day 1;
    Subject has a history of anaphylaxis of unknown cause or severe allergic reactions of unknown cause or has a known hypersensitivity or allergic reactions to one of the components of the vaccine;
    Subject had any malignancy in the past 5 years;
    Subject is pregnant, has plans to become pregnant during the course of the study or is lactating at the time of enrollment;
    Subject has donated or plans to donate blood or blood-derived products 4 weeks prior to Day 1;
    Subject has any condition that may compromise its well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;
    Subject is in a dependent relationship with the sponsor/investigator
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    + Frequency of solicited local and solicited systemic AEs within 7 days after each and any vaccination of the primary vaccination series (Part A).

    Immunogenicity:
    + GMTs (Geometric Mean Titers) for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay, at Day 208/Month 7 (Part A).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint was evaluated at Day 208 (which is one month after completion of primary vaccination series)
    E.5.2Secondary end point(s)
    Safety:
    + Frequency of solicited local and solicited systemic AEs within 7 days after each booster dose administration (Part B);
    + Frequency of SAEs during the entire study;
    + Frequency of AESIs during the entire study;
    + Frequency of unsolicited AEs within 28 days after each vaccination;
    + Frequency of SAEs, AESIs, unsolicited and solicited AEs stratified by age cohort.

    Immunogenicity:
    Part A: Main Study Phase:
    + GMTs for IgG against each OspA serotype (ST1 to ST6), determined by an IgG binding assay, at baseline (screening visit) and at Day 85, 180, 194, 365 and Month 18;
    + SCRs (Seroconversion Rate, defined as seroconversion from seronegative to seropositive or ≥four-fold increase in IgG titer compared to baseline if subject was tested OspA seropositive at baseline) for each OspA serotype specific IgG (ST1 to ST6), determined by an IgG binding assay, at Day 85, 180, 194, 208, 365 and Month 18;
    + GMFRs (Geometric Mean of the fold rise as compared to baseline) for IgG against each OspA serotype (ST1 to ST6), determined by an IgG binding assay, at Day 85 and 208;
    + GMTs, SCRs and GMFRs for IgG against each OspA serotype (ST1 to ST6), determined by an IgG binding assay, at specified time-points, stratified by age cohort.

    Part B: Booster Phase:
    + GMTs for IgG against each OspA serotype (ST1 to ST6), determined by an IgG binding assay, at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48;
    + SCRs for each OspA serotype specific IgG (ST1 to ST6), determined by an IgG binding assay, at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48;
    + GMFRs for IgG against each OspA serotype (ST1 to ST6), determined by an IgG binding assay, at Months 19, 31 and 43;
    + GMTs, SCRs and GMFRs for IgG against each OspA serotype (ST1 to ST6), determined by an IgG binding assay, at specified time points, stratified by age cohort.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Solicited: AEs were assessed within 7 days after each vaccine.
    Unsolicited: AEs were assessed within 28 days after vaccine, SAEs and AESIs were assessed during entire study duration.

    Blood samples for immunogenicity analysis were collected at:
    Part A: M0 (Baseline), M3, M6, M6.5 (only in a subset of adults), M7, M12, M18
    Part B: M19, M23, M26, M30, M31, M39, M42, M43 and M48
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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) 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 Yes
    E.8.1.5Parallel group Yes
    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 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
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years4
    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: 300
    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: 150
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 150
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    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 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 under the age of 18
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children under the age of 18
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 625
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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