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    Summary
    EudraCT Number:2007-002777-32
    Sponsor's Protocol Code Number:110659
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-07
    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 ConcernedGermany - PEI
    A.2EudraCT number2007-002777-32
    A.3Full title of the trial
    A phase I/II, partially blind, randomized, multicentre, age-stratified, dose-range study in healthy females aged 9 - 25 years to assess the safety and immunogenicity of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 2-dose schedule (0, 2-month or 0, 6-month) when compared to a standard 3-dose schedule of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the safety and immunogenicity of GlaxoSmithKline Biologicals’ HPV vaccine 580299 when administered in healthy females aged 9 - 25 years using an alternative schedule and an alternative dosing as compared to the standard schedule and dosing
    A.3.2Name or abbreviated title of the trial where available
    HPV-048 PRI
    A.4.1Sponsor's protocol code number110659
    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.5.5Fax number--------
    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 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 nameProphylactic HPV-16/18 L1 VLP (40µg/40µg) AS04 vaccine
    D.3.2Product code HPV-16/18 L1 VLP (40µg/40µg) AS04 vaccine
    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.3.9.3Other descriptive nameHPV-16 L1 VLP antigen
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameHPV-18 L1 VLP antigen
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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: 2
    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 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.3.2Product code HPV-16/18 L1 VLP AS04 vaccine
    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.3.9.3Other descriptive nameHPV-16 L1 VLP antigen
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameHPV-18 L1 VLP antigen
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    For active immunization of females for the prevention of cervical cancer by protecting against persistent infections, cytological abnormalities including atypical squamous cells of undetermined significance (ASC-US), cervical intraepithelial neoplasia (CIN) and pre-cancerous lesions (CIN 2/3) caused by oncogenic human papillomavirus (HPV) types 16 and 18.
    E.1.1.1Medical condition in easily understood language
    Cervarix is a vaccine that protects women against infection caused by Human Papillomavirus (HPV) type 16 and type 18. These viruses can infect the skin or the genitals, which can lead to cancer.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10063001
    E.1.2Term Human papilloma virus infection
    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 evaluate the immunogenicity of the HPV-16/18 L1 VLP AS04 vaccine one month after the last dose when administered at different dosages (20 or 40 µg of each HPV antigen) and on different schedules (0, 2- or 0, 6-months) compared with the standard HPV-16/18 L1 VLP AS04 vaccine administered on a 3-dose schedule (0, 1, 6-months).
    To evaluate the reactogenicity of the HPV-16/18 L1 VLP AS04 vaccine when administered at different dosages (20 or 40 µg of each HPV type) and on different schedules (0, 2- or 0, 6-months) with respect to the occurrence, intensity and relationship to vaccination of solicited local and general symptoms reported within 7 days (Days 0 - 6) after each and any vaccination.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of the HPV-16/18 L1 VLP AS04 vaccine when administered at different dosages and on different schedules up to Month 60.To demonstrate the non-inferiority of the antibody response to the 2-dose schedule of the HPV-16/18 L1 VLP AS04 vaccine in the 9-14, then in the 15-19 and then in the 20-25 year age strata (these 3 objectives will be assessed sequentially) when administered at different dosages and on different schedules as compared to the standard 3-dose schedule in subjects 15-25 years of age, one month after the last dose of vaccine.If any of the above secondary objectives for immunogenicity are demonstrated:To examine pair-wise comparisons of the antibody response between each 2-dose schedule group and the standard 3-dose schedule, one month after the last dose of vaccine within each age stratum.To evaluate the antibody response to all dose schedules and dosages of the HPV-16/18 L1 VLP AS04 vaccine in each age stratum during the extended follow-up period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subjects who the investigator believes that they and/or their parents can and will comply with the requirements of the protocol should be enrolled in the study.
    •A female subject between, and including, 9 and 25 years of age at the time of the first vaccination.
    •Written informed consent/assent obtained from the subject prior to enrolment. For subjects above the legal age of consent, written informed consent must be obtained from the subject. For subjects below the legal age of consent, written informed consent from the subject’s parents/legally acceptable representative, and written informed assent must be obtained from the subject.
    •Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
    •Subjects must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be pre-menarcheal; or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
    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.
    •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent,>0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
    •Concurrently participating in another clinical study, at any time during the study period (up to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
    •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. Days 0 - 29) the first dose of vaccine. Planned administration/administration of routine meningococcal, hepatitis A or B, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines, up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
    •Pregnant or breastfeeding female.
    •A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose.
    •Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (up to Month 24).
    •Previous administration of MPL or AS04 adjuvant.
    •Cancer or autoimmune disease under treatment.
    •Any medically diagnosed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
    •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. MPL, AS04.
    •Hypersensitivity to latex (found in syringe-tip cap and plunger).
    •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 illness, i.e. Oral temperature < 37.5°/Axillary temperature < 37.5°C).
    •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
    •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 (up to Month 24).
    E.5 End points
    E.5.1Primary end point(s)
    •HPV-16 and HPV-18 antibody titres (by ELISA) assessed one month after the last dose of vaccine when administered at different dosages (20 or 40 µg of each HPV type) and on different schedules (0, 2- or 0, 6 or 0, 1, 6-months).
    Safety
    •Occurrence, intensity and causal relationship to vaccination of solicited local and general symptoms within 7 days (Days 0 - 6) after each and any vaccination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month after the last dose of vaccine
    Safety: 7-day period following each vaccination
    E.5.2Secondary end point(s)
    •Occurrence, intensity and causal relationship to vaccination of unsolicited symptoms within 30 days (Days 0 - 29) after any vaccination.
    •Occurrence of serious adverse events (SAEs) up to Month 7 and during the extended safety follow-up period (up to Month 60).
    •Occurrence of medically significant conditions (MSCs) up to Month 7 and during the extended safety follow-up period (up to Month 60), regardless of causal relationship to vaccination and intensity.
    •Occurrence of New Onset Chronic Diseases (NOCD)/New Onset Autoimmune Diseases (NOAD) (e.g. autoimmune disorders, asthma, type I diabetes, allergies, etc…), regardless of causal relationship to vaccination and intensity.
    •Occurrence of pregnancies and pregnancy outcomes.
    •Changes in haematological and biochemical parameters from blood samples taken from all subjects at Month 0 and Month 7.
    •HPV-16 and HPV-18 antibody titres (by ELISA) assessed one month after the last dose of vaccine (Month 7) in all study groups and in all age strata.
    •HPV-16 and HPV-18 antibody titre (by ELISA) assessed one month after the second dose of vaccine in the 2-dose schedule groups (Month 3).
    •HPV-16 and HPV-18 antibody titres (by ELISA) and seroconversion status assessed during the extended follow-up period ( up to Month 60).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Unsolicited symptoms: 30-day period following each vaccination.
    SAEs, MSCs, NOCD/NOAD and pregnancy: Throughout the study period.
    Haematological and biochemical parameters: At Day 0 and Month 7.
    ELISA: At Day 0 and Months 3, 7, 12, 18, 24, 36, 48 and 60 (in the 2-dose schedule groups), or at Day 0 and Months 7, 12, 18, 24, 36, 48 and 60 (in the 3-dose schedule group).
    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) 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) 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    partially blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned21
    E.8.5The trial involves multiple Member States No
    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
    Canada
    Germany
    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
    The end of the trial is planned at Month 7 (study conclusion at Month 7). The extended safety and immunogenicity follow-up period will occur until Month 60. The results of interim analyses during the extended follow-up period will be provided in annex reports (at Month 12, Month 18, Month 24, Month 36, Month 48 and Month 60).
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    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: 480
    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: 160
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 320
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 480
    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.4.1In the member state480
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 480
    F.4.2.2In the whole clinical trial 960
    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)
    A plan for treatment or care after the subject has ended the participation in the trial is not provided for prophylactic vaccine studies, as the subjects are healthy pre-teens - adolescents - adults and do not need any treatment or care after end of the study.
    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 Decision2007-08-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-18
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