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    Summary
    EudraCT Number:2011-005697-31
    Sponsor's Protocol Code Number:B1971033
    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:2012-03-12
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2011-005697-31
    A.3Full title of the trial
    A PHASE III STUDY, TO ASSESS THE PERSISTENCE OF hSBA RESPONSE UP TO 48 MONTHS AFTER COMPLETION OF A PRIMARY SERIES OF BIVALENT rLP2086, AND THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF BIVALENT rLP2086.
    KLINICKÉ HODNOCENÍ FÁZE 3 POSUZUJÍCÍ PŘETRVÁVÁNÍ ODPOVĚDI hSBA PO DOBU AŽ 48 MĚSÍCŮ OD DOKONČENÍ PRIMÁRNÍHO CYKLU OČKOVÁNÍ BIVALENTNÍ VAKCÍNOU rLP2086 A BEZPEČNOST, TOLERANCI A IMUNOGENITU POSILOVACÍ DÁVKY BIVALENTNÍ VAKCÍNY rLP2086
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to find out how long a person continues to have antibodies against Meningococcal B disease following vaccination
    A.4.1Sponsor's protocol code numberB1971033
    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., 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 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 800 7181021
    B.5.5Fax number+1 303 7391119
    B.5.6E-mailClinicalTrials.govCallCenter@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 nameN meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine
    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 nameN/a
    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.3.9.1CAS number N/a
    D.3.9.2Current sponsor codeN/a
    D.3.9.3Other descriptive nameN/a
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Meningococcal type B Bacterial Meningitis
    E.1.1.1Medical condition in easily understood language
    Meningococcal type B Bacterial Meningitis
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10027202
    E.1.2Term Meningitis bacterial
    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
    Stage 1:
    To describe the immunogenicity of bivalent rLP2086 as determined by hSBA titers to 4 primary test strains at approximately 6, 12, 18, 24, 36, and 48 months after the last dose (second or third dose) of bivalent rLP2086 or saline in the primary study (ie, a previously conducted Pfizer study using the final formulation and dose of bivalent rLP2086).

    Booster Stage:
    To describe the immune response as measured by hSBA titers to 4 primary test strains 1 month after the last dose (second or third dose) of bivalent rLP2086 in the primary study, before the booster vaccination, and 1 month, 12 months, and 26 months after a single booster dose of bivalent rLP2086.

    Primary Safety Objective (Booster Stage):
    Please refer to the Protocol Section 2.1.2.

    Exploratory Objectives for Stage 1 and Booster Stage):
    Please refer to the Protocol Section 2.1.3
    E.2.2Secondary objectives of the trial
    There are no Secondary Objectives for this Study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet the following Stage 1 inclusion criteria to be eligible for enrollment into Stage 1 of the study. The criteria listed for the Booster Stage are required, in addition to Stage 1 inclusion criteria, in order to be eligible to continue into the booster stage of the
    study.

    Stage 1:
    1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.

    2. Subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.

    3. Subjects who completed a primary study and received all the scheduled injections within the originally planned schedule, either with bivalent rLP2086 (either 2 or 3 doses) or with investigational product in cases where subject vaccine assignment is blinded at the time of consent for Study B1971033.

    4. Subjects who completed the blood draw following the last vaccination and subjects who completed the 6-month follow-up telephone call in the primary study.

    Booster Stage Visits 7 to 10:
    1. Evidence of a personally signed and dated ICD indicating that the subject or subject’s parent(s)/legal guardian has been informed of all pertinent aspects for Visits 7 to 10 of the booster stage of the study.

    2. Subject continues to meet all Stage 1 inclusion and none of the Stage 1 exclusion criteria.

    3. Subject is confirmed as having received bivalent rLP2086 in the primary vaccination study.

    4. Subject has completed B1971033 Stage 1 and completed the Visit 6 blood draw.

    5. Subject is available for the entire period of the booster stage and the subject or subject’s parent(s)/legal guardian 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 and at risk for pregnancy must agree to use a highly effective method of
    contraception through Visit 10 of the booster stage. 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 on the day of
    the booster dose.

    Booster Stage Visit 11:
    1. For subject participating in Visit 11, evidence of a personally signed and dated ICD indicating that the subject or subject's parent(s)/legal guardian has been informed of all pertinent aspects of Visit 11.
    2.Subject continue to meet all Stage 1 inclusion and none of the Stage 1 exclusion criteria.
    3.Subject must have received 2 or 3 doses of bivalent rLP2086 in the primary study on a 0-,2-, and 6-months or a 0- and 6-month schedule.
    4. Subject must have completed booster vaccination at Visit 7.
    E.4Principal exclusion criteria
    The exclusion criteria listed for Stage 1 must not met for enrollment in Stage 1 of the study. In order to be eligible for enrollment into the booster stage of the study, the exclusion criteria listed for the booster stage must not to be met, in addition to not meeting any of the
    exclusion criteria for Stage 1.

    Criteria are listed for Stage 1 and the booster stage of the study.

    Stage 1:
    1. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.

    2. With the exception of the primary study of bivalent rLP2086, participation in other studies within the 1-month (30-day) period before study Visit 1 and/or during study participation. Participation in purely observational studies is permitted.

    3. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation 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.

    4. History of culture-proven disease caused by N meningitidis or Neisseria gonorrhoeae.

    5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate blood draw.

    6. Receipt of any blood products, including gamma globulin, in the period from 6 months before any study visit.

    7. Vaccination with any licensed or experimental meningococcal serogroup B vaccine since being enrolled in the primary Pfizer-sponsored MnB study (other than study vaccines permitted in the primary study).

    8. Subjects who were not compliant with primary study eligibility criteria while enrolled in the primary study.

    Booster Stage:
    1. Subjects who are scheduled to receive 1 or more doses of a human papillomavirus (HPV) vaccine as part of a 3-dose series during the 28 days after the booster vaccination.

    2. A previous anaphylactic reaction to any vaccine or vaccine-related component.

    3. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.

    4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.

    5. 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.

    6. Significant neurological disorder or history of seizure (excluding simple febrile seizure).

    7. Current chronic use of systemic antibiotics.

    8. Current participation in another investigational study. Participation in purely observational studies is acceptable.

    9. Received any investigational vaccines, drugs, or devices within 28 days before administration of the booster vaccination.

    10. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

    11. Pregnant female subjects, breastfeeding female subjects, male subjects with partners who are currently pregnant, or male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol through Visit 10 of the study.
    E.5 End points
    E.5.1Primary end point(s)
    The 4 primary test strains for hSBA testing are PMB80 (A22 variant), PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44). The lower limit of quantitation (LLOQ) for PMB80 (A22) is an hSBA titer equal to 1:16. The LLOQ for the other 3 primary test strains is an hSBA titer equal to 1:8.

    hSBA assays using the 4 primary test strains will be conducted using sera obtained at Visits 1 to 6 from all subjects entered into stage 1, including subjects who did not receive bivalent rLP2086 in the primary study (B1971015 Group 2).

    Stage 1:
    Proportion of subjects with hSBA titers ≥ LLOQ for each of the 4 primary strains at each blood draw visit in Stage 1 (Visits 1-6).

    Booster Stage
    - Proportions of subjects with hSBA titers ≥ LLOQ for each of the 4 primary strains at 1 month following the last vaccination received in the primary study, before the booster vaccination (Visit 6), and 1 month, 12 months, and 26 months (Visit 8, 10, and 11) following booster vaccination.

    Safety Endpoints (Booster Stage):
    - Percentages of subjects reporting local reactions via the electronic diary (e-diary) by type (pain at the injection site, redness, and swelling) and by severity after a booster vaccination of bivalent rLP2086.

    - Percentages of subjects reporting systemic events via the e-diary by type (fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain) and by severity after a booster vaccination of bivalent rLP2086.

    - Percentage of subjects reporting the use of antipyretic medication via the e-diary after a booster vaccination of bivalent rLP2086.

    - Percentages of subjects with at least 1 AE occurring during the following time periods:
    - From Visit 7 to Visit 8

    - Percentages of subjects with at least 1 SAE during the following periods:
    - From Visit 7 to Visit 8
    - From Visit 8 to Visit 9
    - From Visit 7 to Visit 9

    - Percentages of subjects with at least 1 NDCMC occurring during the following time periods:
    - From the 6-month safety telephone call in the primary study to Visit 6 (Stage 1)
    - From Visit 7 to Visit 8
    - From Visit 8 to Visit 10
    - From Visit 7 to Visit 10 -From Visit 8 to Visit 11 (only subjects proceeding to Visit 11) -From Visit 7 to Visit 11 (only subjects proceeding to Visit 11)

    - Percentages of subjects with at least 1 medically attended event occurring during the following time periods:
    - From Visit 7 to Visit 8
    - From Visit 8 to Visit 9
    - From Visit 7 to Visit 9

    - Percentage of subjects reporting at least 1 immediate AE after receiving the booster dose of bivalent rLP2086.

    - Number of days subjects miss school or work because of AEs from Visit 7 through Visit 9.

    For the Exploratory Endpoints for Stage 1 and Booster Stage:
    Please refer to Protocol Section 2.2.4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood draws for serology assessment at 6, 12, 18, 24, 36, and 48 months after last dose of bivalent rLP2086, or after last injection of
    investigational product in primary study
    E.5.2Secondary end point(s)
    Not Applicable in this case.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable in this case.
    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 No
    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
    Duration of immunity.
    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 No
    E.8.1.1Randomised No
    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 No
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    As per Protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    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: 1128
    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: 204
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 924
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 72
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-03-12. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 1200
    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 as not applicable in this case.
    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 Decision2012-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-05
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