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    Summary
    EudraCT Number:2004-001325-14
    Sponsor's Protocol Code Number:580299/008
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-04-15
    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
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-001325-14
    A.3Full title of the trial
    Estudio en fase III, doble ciego, aleatorizado, controlado, multicéntrico para evaluar la eficacia de la vacuna HPV-16/18 VLP/AS04 de GlaxoSmithKline Biologicals comparada con la vacuna antihepatitis A como control en la prevención de la infección cervical persistente por el HPV-16 o HPV-18 y del cáncer de cérvix, administrada por vía intramuscular conforme a la pauta de vacunación 0, 1 y 6 meses, en mujeres sanas entre 15 y 25 años
    A phase III, double-blind, randomized, controlled study to evaluate the efficacy of GlaxoSmithKline Biologicals’ HPV-16/18 VLP/AS04 vaccine compared to hepatitis A vaccines as control in prevention of persistent HPV-16 or HPV-18 cervical infection and cervical neoplasia, administered intramuscularly according to a 0, 1, 6 month schedule in healthy female subjects aged 15 – 25 years or age.
    A.3.2Name or abbreviated title of the trial where available
    HPV-008
    A.4.1Sponsor's protocol code number580299/008
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline SA
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 bivalent HPV/AS04 Vaccine Candidate
    D.3.2Product code HPV
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 & HPV-18 L1 VLP (recombinant L1 proteins assembled as Virus-Like Particles)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameHAVRIX based investigational Hepatitis A vaccine (720 Elisa units of antigen)
    D.3.2Product code HAV
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 name720 EL.U of formaldehyde-inactivated hepatitis A virus (HM175 hepatitis A virus strain)
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number720 to ELISA UNIT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    cervical cancer => study is conducted in healthy female
    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
    primary objectives:
    - To demonstrate efficacy of the candidate vaccine compared with control in the prevention of histopathologically confirmed CIN2+ associated with HPV-16 or HPV-18 cervical infection detected in the preceding cytological specimen (by PCR) post dose 3 (after Month 6 to Month 48) in adolescent and young adult women who are negative for HPV DNA (by PCR) at Months 0 and 6 for the corresponding HPV type

    The principal analysis will be performed on subjects who are seronegative (by ELISA) prior to vaccination for the corresponding HPV type present in the sample.

    E.2.2Secondary objectives of the trial
    For all serostratified secondary and exploratory efficacy analyses, the principal analysis will be performed on subjects who are seronegative (by ELISA) prior to vaccination for the corresponding HPV type present in the sample.
    -safety of HPV vaccine throughout study period
    -efficacy of the candidate vaccine compared with control in the prevention of histopathologically confirmed CIN2+ associated with the following oncogenic HPV types (or combination of types) detected within the lesional component of the cervical tissue specimen (by PCR): HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68
    -•efficacy of the candidate vaccine compared with control in the prevention of histopathologically confirmed CIN1+ associated with the following oncogenic HPV types (or combination of types) detected within the lesional component of the cervical tissue specimen (by PCR): HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 (please refer to protocol)
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Female subjects 15 – 25 years of age who have a negative urine pregnancy test at the time of the first vaccination. (If they are of childbearing potential at the time of study entry, they must be abstinent or must be using an effective method of birth control.)
    - No more than 6 lifetime sexual partners prior enolment
    - Subject must have intact cervix
    E.4Principal exclusion criteria
    - Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy
    - Planning to become pregnant or planning to discontinue contraceptive during he first 9 months of the study.
    - Previous administration of monophosphoryl lipid A (MPL) or AS04 adjuvant (no vaccines currently licensed contain these).
    - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) 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.
    - History of vaccination against Hepatitis A or a known clinical history of Hepatitis A disease (no laboratory testing required).
    - Previous vaccination against human papillomavirus (HPV).
    - History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.
    - Planned administration/administration of a vaccine (except Meningococcal, Hepatitis B, Inactivated Influenza, and Diptheria/Tetanus) not foreseen by the study protocol within 30 days before and after the administration of each dose of vaccine.
    - Planned administration/administration of routine vaccines such as Meningococcal, Hepatitis B, Inactivated Influenza, and Diphtheria/Tetanus and/or Diphtheria/Tetanus-containing vaccine within 8 days before and 30 days after the administration of each vaccine.
    - Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination (no laboratory testing required).
    - History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines, e.g. MPL, AS04, Hepatitis A antigen, 2-phenoxyethanol or neomycin.
    - Hypersensitivity to latex (found in syringe-tip cap and plunger).
    - Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
    - History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes, or autoimmune disease.
    - Received immunoglobulins and/or blood product within 90 days preceding enrollment. Enrollment will be deferred until the subject is outside of specified window.
    - Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Enrollment will be deferred until condition is resolved. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/axillary temperature <37.5°C (99.5°F).
    - Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic exam cannot be performed. Enrollment will be deferred until condition is resolved according to investigators medical judgement.
    E.5 End points
    E.5.1Primary end point(s)
    Histopathological
    - Histopathologically confirmed CIN2+ associated with HPV-16 or HPV-18 cervical infection detected in the preceding cytological specimen (by PCR).
    CIN2+ (cervical intraepithelial neoplasia) is defined as CIN2, CIN3, adenocarcinoma in-situ (AIS), and invasive cervical cancer.
    Preceding cytological specimen is defined as the last cervical cytology specimen collected before the histopathology specimen was obtained.

    The principal analysis will be performed on subjects who are seronegative (by ELISA) prior to vaccination for the corresponding HPV type present in the sample.
    (Amended 11 October 2006)
    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 Information not present in EudraCT
    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) 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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    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 Information not present in EudraCT
    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 2010-04-15. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4500
    F.4.2.2In the whole clinical trial 18000
    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)
    Subject to the approval by the study Independent Data Monitoring Committee and national regulatory authorities in participating countries, cross-over immunization of both treatment and control recipients with the HPV vaccine and licensed Havrix respectively, will be offered. HPV vaccine used in the study is commercialized in Spain.This modification describes perfectly how cross-vaccination will be done at study end.
    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 Decision2004-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-06-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-11-26
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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