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    Summary
    EudraCT Number:2017-000416-42
    Sponsor's Protocol Code Number:106069
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-09-15
    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 number2017-000416-42
    A.3Full title of the trial
    A phase IIIb, double-blind, randomized, controlled, multicentre study to assess the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 months) in healthy female subjects aged 10-25 years.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study is to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Human Papillomavirus (HPV) vaccine (GSK580299) in healthy female subjects 10-25 years of age (inclusive).
    A.3.2Name or abbreviated title of the trial where available
    HPV-021
    A.4.1Sponsor's protocol code number106069
    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 SponsorGlaxoSmithKline Biologicals
    B.1.3.4CountryBelgium
    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 supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de l'Institut, 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number442089904466
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 Yes
    D.2.1.1.1Trade name CERVARIX
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals
    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.3.4Pharmaceutical 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 INN-
    D.3.9.2Current sponsor codeHPV-16 L1
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB22593
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.2Current sponsor codeHPV-18 L1
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB22594
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 in pre-filled syringe
    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
    Healthy volunteers [For active immunisation of healthy adolescents and young adult females from the age of 10 to 25 years for the prevention of persistent infection, premalignant genital (cervical, vulvar and vaginal) lesions and cervical, vulvar and vaginal cancers (squamous-cell carcinoma and adenocarcinoma) caused by oncogenic Human Papillomaviruses (HPV) types 16 and 18].
    E.1.1.1Medical condition in easily understood language
    Human Papillomavirus (HPV) infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    • To evaluate antibody responses enzyme-linked immunosorbent assay (ELISA) against HPV-16 and HPV-18 at Month 7 in subjects 15-25 years of age.
    • To evaluate the antibody responses against HPV-16 and HPV-18 at Month 7 in subjects 10-14 years of age.
    E.2.2Secondary objectives of the trial
    • To evaluate antibody responses (ELISA) against HPV-16 and HPV-18 in all subjects at Month 2 and Month 12.
    • To evaluate the safety and reactogenicity of the study vaccine in all subjects throughout the entire study period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects who the investigator believes that they and/or their parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g., return for follow-up visits) should be enrolled in the study.
    • A female between, and including, 10 and 25 years of age at the time of the first vaccination.
    • Written or oral, signed or thumb printed or witnessed informed consent obtained from the subject prior to enrolment.

    For subjects below legal age of consent, written or oral, signed or thumb printed or witnessed informed consent obtained from the subject’s parent or legally acceptable representative. In addition, a written or oral, signed or thumb printed and witnessed informed assent must be obtained from the subject.
    • Free of obvious health problems as established by medical history, clinical examination and laboratory testing before entering into the study.
    • Subjects must have a negative urine pregnancy test at the screening visit and at Visit 1 (Day 0).
    • Subjects must be seronegative for human immunodeficiency virus (HIV) at the screening visit.
    • Subjects must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine con-traceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant or DepoProvera; progestogen-only implantable cutaneous hormonal patch or injectable con-traceptives) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions.
    • Subjects must have had no more than 6 sexual partners prior to enrolment.
    • Subjects must be willing to undergo HIV voluntary counselling and testing (VCT) and must be willing to be in-formed of their HIV status.

    Subjects below legal age of consent must also be willing to have their parent or legally acceptable representative informed of their HIV status.
    E.4Principal exclusion criteria
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).
    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned administration during the study period. (For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
    • Administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine. Enrolment will be deferred until the subject is outside of specified window.
    • Planned administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. Days 0 - 29) any dose of study vaccine.
    • Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Month 0 to 12).
    • Previous administration of MPL or AS04 adjuvant.
    • Cancer or autoimmune disease under treatment.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection based on laboratory testing performed during the screening visit.
    • Hypersensitivity to latex (found in syringe-tip cap and plunger).
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine/control (e.g. aluminium, MPL).
    • Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile ill-ness, i.e., Oral temperature/axillary temperature =< 37.5°C).
    • Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory testing performed at the screening visit.
    • History of any neurologic disorders or seizures.
    • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
    • Pregnant or breastfeeding female.
    • A woman planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose (i.e. up to Month 8).
    • Concurrently participating in another clinical study, at any time during the study period (up to Month 12), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
    E.5 End points
    E.5.1Primary end point(s)
    Number of seroconverted subjects for anti-HPV-16 and anti-HPV-18 antibodies.
    Geometric mean titers (GMTs) for anti-HPV-16 and anti-HPV-18 antibodies.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Month 7
    E.5.2Secondary end point(s)
    1. HPV-16 and HPV-18 seroconversion rates and GMTs in all subjects.
    2. Number of subjects with any and Grade 3 solicited local symptoms
    3. Number of subjects with any, Grade 3 and related solicited general symptoms
    4. Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)
    5. Number of subjects with new onset of chronic disease (NOCDs) and other medically significant conditions (MSCs)
    6. Number of subjects with serious adverse events (SAEs)
    7. Number of subjects with pregnancies and their outcomes
    8. Number of Senegalese subjects with clinically relevant abnormalities in biochemical and haematological parameters
    9. Number of Tanzanian subjects with clinically relevant abnormalities in biochemical and haematological parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At Month 2 and Month 12
    2. Within 7 days (Days 0-6) after each and any vaccination
    3. Within 7 days (Days 0-6) after each and any vaccination
    4. Within 30 days (Days 0-29) after any vaccination
    5. From Day 0 up to Month 7 and from Month 7 up to Month 12
    6. From Day 0 up to Month 7 and from Month 7 up to Month 12
    7. From Day 0 up to Month 7
    8. At Day 0, Month 7 and Month 12
    9. At Month 7 and Month 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 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
    Senegal
    Tanzania, United Republic of
    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 years1
    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: 454
    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: 232
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 222
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 222
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 676
    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)
    When subjects have completed the study, the opportunity will be given to all the subjects to be vaccinated with a licensed vaccine (the choice of the vaccine will depend on the country).
    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: Senegal
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