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    Summary
    EudraCT Number:2016-004421-17
    Sponsor's Protocol Code Number:B1971057
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-22
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2016-004421-17
    A.3Full title of the trial
    A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT rLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMAN STUDY TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A BIVALENT rLP2086–CONTAINING PENTAVALENT VACCINE (MenABCWY) IN HEALTHY SUBJECTS ≥ 10 TO < 26 YEARS OF AGE
    RANDOMIZOVANÁ, AKTIVNĚ KONTROLOVANÁ, PRO POZOROVATELE ZASLEPENÁ STUDIE FÁZE 3 K POSOUZENÍ IMUNOGENICITY, BEZPEČNOSTI A TOLERANCE BIVALENTNÍ VAKCÍNY rLP2086 PODÁVANÉ V REŽIMU 2 DÁVEK A PRVNÍ STUDIE U ČLOVĚKA POPISUJÍCÍ IMUNOGENICITU, BEZPEČNOST A TOLERANCI PENTAVALENTNÍ VAKCÍNY (MenABCWY) OBSAHUJÍCÍ BIVALENTNÍ VAKCÍNU rLP2086 U ZDRAVÝCH SUBJEKTŮ VE VĚKU ≥ 10 AŽ < 26 LET
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to find out if vaccines designed to protect against a disease (meningococcal meningitis) is safe and protects people aged 10 to < 26 years
    A.4.1Sponsor's protocol code numberB1971057
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/013/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc. 235 East 42nd Street, New York, NY 10017
    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, 235 East 42nd Street, New York, NY 10017
    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 Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number001800718 1021
    B.5.5Fax number0013037391119
    B.5.6E-mailclinicaltrials.gov_inquiries@pfizer.com
    D. IMP Identification
    D.IMP: 1
    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 Menveo
    D.2.1.1.2Name of the Marketing Authorisation holderGSK Vaccines s.r.l.
    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 nameMenACWY-CRM
    D.3.4Pharmaceutical form Solution for injection/infusion 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 INNMENINGOCOCCAL GROUP A OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameMENINGOCOCCAL GROUP A OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN
    D.3.9.4EV Substance CodeSUB77061
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE CONJUGATED CRM197
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE CONJUGATED CRM197
    D.3.9.4EV Substance CodeSUB26743
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN. MENINGITIDIS GROUP W135 OLIGOSACCHARIDE CONJUGATED CRM197
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP W135 OLIGOSACCHARIDE CONJUGATED CRM197
    D.3.9.4EV Substance CodeSUB31083
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMENINGOCOCCAL GROUP Y OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameMENINGOCOCCAL GROUP Y OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN
    D.3.9.4EV Substance CodeSUB126362
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 nameBivalent rLP2086
    D.3.2Product code PF-05212366
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMnB rLP2086 Subfamily A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameMENINGOCOCCAL SEROGROUP B RECOMBINANT LP2086 (MNB RLP2086) SUBFAMILY A PROTEIN
    D.3.9.4EV Substance CodeSUB31503
    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 INNMnB rLP2086 Subfamily B
    D.3.9.3Other descriptive nameMENINGOCOCCAL SEROGROUP B RECOMBINANT LP2086 (MNB RLP2086) SUBFAMILY B PROTEIN
    D.3.9.4EV Substance CodeSUB31504
    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.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 nameMenABCWY
    D.3.4Pharmaceutical form Solution for 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 INNMENINGOCOCCAL SEROGROUP B RECOMBINANT LP2086 (MNB RLP2086) SUBFAMILY A PROTEIN
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameMENINGOCOCCAL SEROGROUP B RECOMBINANT LP2086 (MNB RLP2086) SUBFAMILY A PROTEIN
    D.3.9.4EV Substance CodeSUB31503
    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 INNMENINGOCOCCAL SEROGROUP B RECOMBINANT LP2086 (MNB RLP2086) SUBFAMILY B PROTEIN
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameMENINGOCOCCAL SEROGROUP B RECOMBINANT LP2086 (MNB RLP2086) SUBFAMILY B PROTEIN
    D.3.9.4EV Substance CodeSUB31504
    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 INNNEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36479
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36481
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36482
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE (DE-O-ACETYLATED) CONJUGATED TO TETANUS TOXOID
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE (DE-O-ACETYLATED) CONJUGATED TO TETANUS TOXOID
    D.3.9.4EV Substance CodeSUB26116
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W and Y in individuals 10 through 25 years of age.
    E.1.1.1Medical condition in easily understood language
    Meningococcal infection
    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 10027249
    E.1.2Term Meningitis meningococcal
    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 Immunogenicity objective:
    To assess the immune response induced by bivalent rLP2086 as measured by serum bactericidal assay using human complement (hSBA) performed with 4 primary MnB test strains, 2 expressing a lipoproten 2086 (LP2086) subfamily A protein and 2 expressing an LP2086 subfamily B protein, measured 1 month after the second vaccination, in the bivalent rLP2086 arms (Group 2 and 4 subjects) combined.

    Primary Safety Objectives:
    - To describe the safety profile of bivalent rLP2086, as measured by local reactions, systemic events, adverse events (AEs), serious adverse events (SAEs), newly diagnosed chronic medical conditions, medically attended AEs, and immediate AEs, following Vaccinations 1 and 2 in the bivalent rLP2086 arms (Group 2 and 4 subjects) combined.

    - To describe the safety profile of MenABCWY after the booster
    vaccination.

    - To describe the safety profile of bivalent rLP2086 after the booster
    vaccination.
    E.2.2Secondary objectives of the trial
    Secondary immunogenicity objectives:
    - To describe the immune response induced by bivalent rLP2086 as measured by hSBA performed with 4 primary MnB test strains, 2 expressing an LP2086 subfamily A protein and 2 expressing an LP2086 subfamily B protein, measured 1 month after the second vaccination, in the bivalent rLP2086 arms (Group 2 and 4 subjects) combined.
    - To describe the MenB immune response as measured by hSBA performed with secondary MenB test strains measured 1 month after the second vaccination in
    Groups 2 and 4 combined.
    - To describe the immune response induced by 1 dose of MenABCWY compared to the immune response induced by 1 dose of MenACWY-CRM, as measured by hSBA performed with ACWY test strains, in ACWY-naive and ACWY-experienced subjects separately.

    Additional secondary immunogenicity objectives and all secondary safety objectives are listed in the study Protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (or parent(s)/legal guardian) has been informed of all pertinent aspects of the study.
    2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    3. Male and femle subject aged ≥10 and <26 years, at the time of randomization.
    4. Subjects who have never received a prior dose, or who have received not more than 1 prior dose no sooner than 4 years prior to the date of randomization, of a vaccine containing 1 or more ACWY groups. Written confirmation of ACWY vaccination history should be obtained prior to randomization; however, if written ACWY vaccination history is not available, history obtained verbally from the subject (or parent(s)/legal guardian) is acceptable, if deemed reliable by the investigator.
    5. Available for the entire study period and can be reached by telephone.
    6. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
    7. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout Stage 1 (through the follow-up telephone contact at Month 12), and from Visit 10 (booster vaccination) to Visit 11. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
    8. Negative urine pregnancy test for all female subjects.
    E.4Principal exclusion criteria
    Subjects with any of the following characteristics/conditions will not be included in the study:
    1. Previous vaccination with any meningococcal group B vaccine or any purely polysaccharide (nonconjugate) meningococcal vaccine. Written vaccination history should be obtained prior to randomization; however, if written vaccination history is not available, history obtained verbally from the subject (or parent(s)/legal guardian) is acceptable, if deemed reliable by the investigator.
    2. Previous vaccination with >1 dose of a vaccine containing 1 or more ACWY group.
    3. Subjects having received 1 prior dose of a vaccine containing 1 or more ACWY group <4 years prior to the date of randomization.
    4. A previous anaphylactic reaction to any vaccine or vaccine-related component.
    5. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
    6. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
    7. A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are
    excluded from participation in this study. Please refer to the study reference manual (SRM) for additional details.
    8. History of microbiologically proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
    9. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
    10. Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.
    11. Current chronic use of systemic antibiotics.
    12. Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.
    13. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
    14. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    15. Investigator site staff members directly involved in the conduct of the study and their embers, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
    16. Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in the Protocol Section 4.5.
    E.5 End points
    E.5.1Primary end point(s)
    Primary immunogenicity endpoints:

    Five (5) coprimary endpoints are defined for the primary objective; they are defined for hSBA performed with each of the 4 primary test strains: PMB80 (A22), PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).
    •One (1) of the 5 coprimary endpoints is the composite endpoint defined as the proportion of subjects achieving an hSBA titer ≥lower limit of quantitation (LLOQ: 1:16 for A22 and 1:8 for A56, B24, and B44)) for all 4 primary test strains combined, 1 month after the second vaccination in the bivalent rLP2086 arms (Group 2 and 4 subjects) combined.
    •Four (4) of the coprimary endpoints are defined as the proportion of subjects achieving at least a 4-fold increase in hSBA titer from baseline to 1 month after the second vaccination in the bivalent rLP2086 arms (Group 2 and 4 subjects) combined for each of the 4 primary test strains.
    •For subjects with a baseline hSBA titer below the limit of detection (LOD, or an hSBA titer of <1:4), a 4-fold response is defined as an hSBA titer of ≥1:16 or the LLOQ (whichever titer is higher).
    •For subjects with a baseline hSBA titer of ≥LOD (ie, hSBA titer of ≥1:4) and < LLOQ, a 4-fold response is defined as an hSBA titer of ≥4
    times the LLOQ.
    •For subjects with a baseline hSBA titer of ≥LLOQ, a 4-fold response is defined as an hSBA titer of ≥4 times the baseline titer.

    Primary Safety endpoints:
    The following endpoints will be described after Vaccinations 1 and 2 in the bivalent rLP2086 arms (Group 2 and 4 subjects) combined.
    •Percentage of subjects reporting local reactions (pain, redness, and swelling) and by severity within 7 days after each vaccination visit.
    •Percentage of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at any injection site, and joint pain) and by severity within 7 days after each vaccination visit.
    •Percentage of subjects reporting the use of antipyretic medication within 7 days after each vaccination visit.
    •Percentage of subjects with at least 1 SAE during the following time periods:
    •30 Days after each vaccination.
    •30 Days after any vaccination.
    •During the Stage 1 vaccination phase (from the first study vaccination [Visit 1] through 1 month after the second study vaccination [Visit 4]).
    •During the Stage 1 follow-up phase (from 1 month after the second study vaccination [Visit 4] through 6 months after the second study vaccination [Visit 5]).
    •Throughout Stage 1 (from the first study vaccination [Visit 1] through 6 months after the second study vaccination [Visit 5]).
    •Percentage of subjects with at least 1 medically attended AE occurring during the following time periods:
    •30 Days after each vaccination.
    •30 Days after any vaccination.
    •During the Stage 1 vaccination phase (from the first study vaccination [Visit 1] through 1 month after the second study vaccination [Visit 4]).
    •During the Stage 1 follow-up phase (from 1 month after the second study vaccination [Visit 4] through 6 months after the second study vaccination [Visit 5]).
    •Throughout Stage 1 (from the first study vaccination [Visit 1] through 6 months after the second study vaccination [Visit 5]).
    •Percentage of subjects with at least 1 newly diagnosed chronic medical condition occurring during the following time periods:
    •30 Days after each vaccination.
    •30 Days after any vaccination.
    •During the Stage 1 vaccination phase (from the first study vaccination [Visit 1] through 1 month after the second study vaccination [Visit 4]).
    •During the Stage 1 follow-up phase (from 1 month after the second study vaccination [Visit 4] through 6 months after the second study vaccination [Visit 5]).
    •Throughout Stage 1 (from the first study vaccination [Visit 1] through 6 months after the second study vaccination [Visit 5]).
    •Percentage of subjects with at least 1 AE occurring during the following time periods:
    •30 Days after each vaccination.
    •30 Days after any vaccination.
    •During the Stage 1 vaccination phase (from the first study vaccination [Visit 1] through 1 month after the second study vaccination [Visit 4]).
    •Percentage of subjects reporting at least 1 immediate AE after each vaccination.
    •Subject days missing school or work because of AEs during the Stage 1 vaccination phase (Visit 1 though Visit 4).

    Please refer to the protocol for additional endpoints that will be described after the booster vaccination in Groups 1 through 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoints are detailed above. Please refer to the protocol for the timepoints for the additional endpoints that will be described after the booster vaccination in Groups 1 through 4.
    E.5.2Secondary end point(s)
    Secondary Immunogenicity endpoints -
    - Proportions of subjects with hSBA titers ≥LLOQ, ≥1:4,≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for each of the 4 primary MenB test strains at Visit 4.
    - hSBA geometric mean titers (GMTs) for each of the 4 primary MnB test strains at Visit 4.
    The secondary immunogenicity endpoints for the subsets tested with the additional hSBA test strains are as follows:
    -Proportions of subjects with hSBA titers ≥LLOQ (1:16 for A06, A12, and A19 and 1:8 for A07, A15, A29, B03,B09, B15, and B16) for each of the secondary test strains 1 month after the second vaccination.
    -Proportions of subjects with hSBA titers ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for each of the secondary test strains 1 month after the second vaccination.
    -hSBA GMTs for each of the secondary test strains 1 month after the second vaccination.
    -Proportions of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titers ≥1:8 (or LLOQ, whichever is higher) at Visit 2.
    -Proportions of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titers ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 at Visit 2.
    -hSBA GMTs for each of the ACWY test strains at Visit 2.
    - Proportions of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titers ≥1:8 (or LLOQ, whichever is higher) at Visit 4 in Groups 1 and 3 and at Visit 2 in Groups 2 and 4.
    -Proportions of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titers ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 at Visit 4 in Groups 1 and 3 and Visit 2 in Groups 2 and 4.
    -hSBA GMTs for each of the ACWY test strains at Visit 4 in Groups 1 and 3 and Visit 2 in Groups 2 and 4.
    - Proportions of subjects who achieve the 5 MnB endpoints 1 month after the second vaccination, which are defined for hSBA performed with each of the 4 primary test strains: PMB80 (A22), PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44), as detailed below:
    -One (1) of the 5 endpoints is the composite endpoint defined as the proportion of subjects achieving an hSBA titer ≥LLOQ (1:16 for A22 and 1:8 for A56, B24, and B44) for all 4 primary test strains combined, 1 month after the second vaccination.
    -Four (4) of the endpoints are defined as the proportion of subjects achieving at least a 4-fold increase in hSBA titer from baseline to 1 month after the second vaccination for each of the 4 primary test strains.
    -For subjects with a baseline hSBA titer below the LOD (ie, an hSBA titer of <1:4), a 4-fold response is defined as an hSBA titer of ≥1:16 or the LLOQ (whichever titer is higher).
    -For subjects with a baseline hSBA titer of ≥LOD (ie, hSBA titer of ≥1:4) and < LLOQ, a 4-fold response is defined as an hSBA titer of ≥4 times the LLOQ.
    -For subjects with a baseline hSBA titer of ≥LLOQ, a 4-fold response is defined as an hSBA titer of ≥4 times the baseline titer.
    -Proportions of subjects with hSBA titers ≥LLOQ, ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for each of the 4 primary MenB test strains at Visit 4.
    -hSBA GMTs for each of the 4 primary MnB test strains at Visit 4.
    - Proportions of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titers ≥1:8 (or LLOQ, whichever is higher) at Visits 1, 3, 7, 8, 9, and 10, in the
    ACWY-naive and ACWY-experienced subjects separately.
    - Proportions of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titers ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 at Visits 1, 3, 7, 8, 9, and 10, in the ACWY-naive and ACWY-experienced subjects separately.
    - hSBA GMTs for each of the ACWY test strains at Visits 1, 3, 7, 8, 9, and 10, in the ACWY-naive and ACWYexperienced subjects separately.
    - Proportions of subjects with hSBA titers ≥ LLOQ, ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for each of the 4 primary MenB test strains at Visits 1, 3, 7, 8, 9, and 10, in the ACWY-naive and ACWY-experienced subjects combined.
    - hSBA GMTs for each of the 4 primary MenB test strains at Visits 1, 3, 7, 8, 9, and 10, in the ACWY-naive and ACWY-experienced subjects combined.

    - Proportions of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titers ≥1:8 (or LLOQ, whichever is higher) at Visit 11.
    - Proportions of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titers ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 at Visit 11.
    - hSBA GMTs for each of the ACWY test strains at Visit 11.
    - Proportion of subjects who achieve the 5 MnB endpoints at Visit 11.
    - Proportions of subjects with hSBA titers ≥ LLOQ, ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for each of the 4 primary MenB test strains at Visit 11.
    - hSBA GMTs for each of the 4 primary MnB test strains at Visit 11.

    - Proportion of subjects who achieve the 5 MnB endpoints 1 month after the booster vaccination.
    Additional secondary immunogenicity endpoint and all secondary safety end points detailed in the Protocol
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints are detailed above
    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
    Tolerability, immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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) 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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned3
    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 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
    Czech Republic
    Finland
    Poland
    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
    End of trial in a Member State of the EU is defined as the time at which it is deemed that a sufficient number of subjects have been recruited and completed the study as stated in the regulatory application (ie, clinical trial application [CTA]) and ethics application in the Member State. Poor recruitment (recruiting less than the anticipated number in the CTA) by a Member State is not a reason for premature termination but is considered a normal conclusion to the study in that Member State.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 1190
    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: 200
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 595
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 795
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 270
    F.4.2.2In the whole clinical trial 1590
    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 plans for care upon completion
    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 Decision2020-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-06
    P. End of Trial
    P.End of Trial StatusCompleted
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