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    Summary
    EudraCT Number:2013-002137-38
    Sponsor's Protocol Code Number:B1971011(6108A1-2007)
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2013-05-23
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2013-002137-38
    A.3Full title of the trial
    A Phase 2, Randomized, ACTIVE-CONTROLLED, observer-blinded Trial, to Assess the Safety, Tolerability, and Immunogenicity of Gardasil® (HPV) Vaccine and BIVALENT RLP2086 Vaccine When Administered Concomitantly in Healthy Subjects Aged ≥ 11 to <18 Years
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study evaluating the safety, tolerability, and immune response to HPV vaccine given together with Bivalent RLP2086 vaccine in healthy subjects ≥ 11 to < 18 years of age.
    A.4.1Sponsor's protocol code numberB1971011(6108A1-2007)
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/93/2013
    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 Center
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    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 nameNeisseria meningitidis Serogroup B Bivalent Recombinant Lipoprotein
    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.3.11 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 placeboSuspension 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 invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MnB) in adolescents and young adults, aged 10 through 25 years.
    E.1.1.1Medical condition in easily understood language
    Prevent invasive disease caused by Neisseria meningitidis serogroup B
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10004049
    E.1.2Term Bacterial meningitis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the immune response (based on geometric mean titer [GMT]) induced by Gardasil given with bivalent rLP2086 vaccine (Group1) is noninferior to the immune response induced by Gardasil alone (Group3) as measured 1month after the 3rd vaccination (Visit5) with Gardasil in both groups. The immune response to all 4 components of Gardasil will be assessed
    To demonstrate the immune response (based on GMT) induced by bivalent rLP2086 vaccine given with Gardasil (Group1) is noninferior to the immune response induced by bivalent rLP2086 vaccine alone (Group2) as measured by serum bactericidal assay using human complement performed with 2 MnB test strains, 1 expressing LP2086 subfamily A and 1 expressing LP2086 subfamily B proteins, when measured 1 month after the third vaccination (Visit5) with bivalent rLP2086 vaccine in both groups
    To evaluate the safety profile of bivalent rLP2086 vaccine as measured by proportion of subjects reporting local reactions, systemic events and AEs
    E.2.2Secondary objectives of the trial
    To describe the immune response as measured by serum bactericidal assay using human complement (hSBA) performed with 4 MnB test strains, 2 expressing LP2086 subfamily A and 2 expressing LP2086 subfamily B proteins, measured 1 month after the third vaccination (Visit 5) with bivalent rLP2086 vaccine (Group 2)
    To describe the immune response as measured by serum bactericidal assay using human complement (hSBA) performed with 4 MnB test strains, 2 expressing LP2086 subfamily A and 2 expressing LP2086 subfamily B proteins, measured 1 month after the second vaccination (Visit 3) with bivalent rLP2086 vaccine (Group 2)
    To demonstrate that the immune response induced by Gardasil given with bivalent rLP2086 vaccine (Group 1) as measured by seroconversion, is non-inferior to the immune response induced by Gardasil® alone (Group 3) when measured 1 month after the third vaccination (Visit 5) with Gardasil® in both groups. The immune response to all 4 serotypes of Gardasil will be assessed
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (and a legally authorized representative) has been informed of all pertinent aspects of the study.
    2. Parent/legally authorized representative and subjects who are willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
    3. Male or female subject aged ≥11 and <18 years at the time of enrollment.
    4. Available for the entire study period and can be reached by telephone.
    5. Healthy subject as determined by medical history, physical examination and judgment of the investigator.
    6. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study (through the follow-up phone contact at month 12). 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. Refer to Section 4.5 for further information.
    7. Negative urine pregnancy test for all female subjects.
    E.4Principal exclusion criteria
    1. Previous vaccination with any meningococcal serogroup B vaccine.
    2. Previous vaccination with any HPV vaccine.
    3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
    4. Contraindication to vaccination with Gardasil® or any HPV vaccine.
    5. Subjects receiving any allergen immunotherapy with a non-licensed 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 with terminal complement deficiency may not be included.
    8. History of any sexually transmitted disease.
    9. History of culture-proven disease caused by Neisseria meningitidis or Neisseria gonorrhoea.
    10. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
    11. Receipt of any blood products, including immunoglobulin within 6 months before the first study vaccination.
    12. Current chronic use of systemic antibiotics.
    13. Participation in other studies during study participation. Participation in purely observational studies is acceptable.
    14. Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination.
    15. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
    16. Other severe acute or chronic medical or psychiatric condition 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.
    17. Subjects who are investigational site staff members or relatives of those site staff members, or who are Pfizer employees directly involved in the conduct of the trial or relatives of those Pfizer employees.
    18. Subject is pregnant or breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints for the first co-primary objective are the geometric mean titers (GMTs) of the 4 HPV antigens (HPV 6, HPV 11, HPV 16, and HPV 18) measured at 1 month after the third vaccination (Visit 5) of Gardasil®, among subjects in Groups 1 and 3. Both baseline seropositive and baseline seronegative subjects will be included in the comparison

    The primary endpoints for the second co-primary objective are the hSBA geometric mean titers (GMTs) of the 2 primary strains (PMB80 [A22], PMB2948 [B24]), measured at 1-month after the third vaccination (Visit 5) of bivalent rLP2086 vaccine, among subjects in Groups 1 and 2.

    All of the safety endpoints will be applied to each group.
    • Proportion of subjects reporting local reactions (pain, redness and swelling) and by severity after each vaccination visit.
    • Proportion 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 after each vaccination visit.
    • Proportion of subjects reporting the use of antipyretic medication after each vaccination visit.
    • Proportion of subjects with at least one SAE during the following time periods:
    • 30 days after each vaccination
    • 30 days after any vaccination
    • During the vaccination phase [from the first study vaccination (Visit 1) through 1 month after the last study vaccination (Visit 5)]
    • During the follow-up phase [from 1 month after the last study vaccination (Visit 5) through 6 months after the third study vaccination (Visit 6)]
    • Throughout the study period [from the first study vaccination (Visit 1) through 6 months after the third study vaccination (Visit 6)].
    • Proportion of subjects who develop at least one adverse event occurring during the following time periods:
    • 30 days after each vaccination
    • 30 days after any vaccination
    • During the vaccination phase [from the first study vaccination (Visit 1) through 1 month after the last study vaccination (Visit 5)]
    • Proportion of subjects reporting at least one immediate adverse event after each vaccination.
    Proportion of subjects reporting at least one newly diagnosed major illnesses, during the follow-up phase [from 1 month after the last study vaccination (Visit 5) through 6 months after the third study vaccination (Visit 6)]
    E.5.1.1Timepoint(s) of evaluation of this end point
    1month post last vaccination(Visit5)for co-primary immunogenicity endpoints
    Local Reactions,Systemic Events,Antipyretic Use 7days after each vaccination
    SAE’s: 30days after each/any vaccination
    During vaccination from first (Visit1)through 1month after last study vaccination (Visit5)
    During follow-up from 1month after last (Visit5)through 6months after third study vaccination(Visit6)
    Throughout study period from first(Visit1)through 6months after third study vaccination(Visit6)
    AE’s 30 days after each vaccination,30 days after any vaccination
    During vaccination from first(Visit1)through 1month after last study vaccination(Visit5)
    Immediate AE’s 30Min after each vaccination
    Newly Diagnosed Major Illness 1month after last(Visit5)through 6months after third study vaccination (Visit6)
    E.5.2Secondary end point(s)
    • The seroconversion rate for each of the 4 HPV antigens, 1 month after the third vaccination (Visit 5) of Gardasil® for subjects with baseline seronegative in Groups 1 and 3. The seroconversion rate is defined as anti HPV serum competitive Luminex® immunoassay (cLIA) levels ≥20 mMU/mL for HPV 6, ≥16 mMU/mL for HPV 11, ≥20 mMU/mL for HPV 16, and ≥24 mMU/mL for HPV 18. A subject having anti HPV serum cLIA levels less than these cutoff points at Visit 1 will be considered baseline seronegative; a subject having anti HPV serum cLIA levels greater than or equal to these cutoff points at Visit 1 will be considered baseline seropositive

    • Proportion of subjects with baseline seropositive for each of the 4 HPV antigens.

    • Proportion of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ), ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, ≥1:128 for each of the 4 primary strains (PMB80 [A22], PMB2001 [A56], PMB2948 [B24], PMB2707 [B44]) at each applicable blood draw time point.

    • hSBA geometric mean titers (GMTs) for each of the 4 primary strains (PMB80 [A22], PMB2001 [A56], PMB2948 [B24], PMB2707 [B44]) at each applicable blood sampling time point
    E.5.2.1Timepoint(s) of evaluation of this end point
    • One month after third vaccination
    • Pre-bleed at visit 1
    • One month after second and third vaccination
    • One month after second and third vaccination
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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 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 blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    saline, gardasile
    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
    The end of the clinical phase of the study will be the telephone contact to the last subject. At this time, sites will be closed out, the institutional review board/independent ethics committee (IRB/IEC) will be informed, and no further Council for International Organizations of Medical Sciences (CIOMS) reports will be sent. For other purposes, the end of the study will be last serology sample assayed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 2500
    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: 300
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 2200
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 2500
    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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