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    The EU Clinical Trials Register currently displays   38497   clinical trials with a EudraCT protocol, of which   6324   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-000757-22
    Sponsor's Protocol Code Number:114700
    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:2011-04-28
    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 number2011-000757-22
    A.3Full title of the trial
    A Phase IIIb open-label, randomised, multi-centre primary immunization study to evaluate the immunogenicity and safety of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine when administered intramuscularly according to alternative 2-dose schedules in 9 - 14 year old healthy females compared to the standard 3-dose schedule for GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine in 15 - 25 year old healthy females.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of immunogenicity and safety of two 2-dose Human Papillomavirus (HPV) vaccine schedules in 9-14 year old girls.
    A.3.2Name or abbreviated title of the trial where available
    HPV-070 PRI
    A.4.1Sponsor's protocol code number114700
    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 supportGlaxoSmithKlineBiologicals
    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 number44208990 4466
    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 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 in pre-filled syringe
    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 nameHUMAN PAPILLOMAVIRUS VACCINE [TYPES 16, 18] (RECOMBINANT, ADJUVANTED, ADSORBED)
    D.3.9.4EV Substance CodeSUB27633
    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.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
    Cervarix is indicated in females from 10 years of age onwards for the prevention of persistent infection, premalignant cervical lesions and cervical cancer (squamous-cell carcinoma and adenocarcinoma) caused by oncogenic human papillomaviruses (HPV) types 16 and 18.
    In addition, Cervarix has shown efficacy against persistent infection caused by oncogenic HPV types other than HPV-16 and HPV-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 17.1
    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 demonstrate that the immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered as a 2-dose schedule of 0,6 months in 9-14 year old females is non-inferior to that administered as the standard 3-dose schedule of 0,1,6 months in 15-25 year old females.
    E.2.2Secondary objectives of the trial
    To demonstrate non-inferiority of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered as a 2-dose schedule of 0,12 months in 9-14 year old females as compared to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females.
    To evaluate if the immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered as a 2-dose schedule of 0,12 months in 9-14 year old females is non-inferior to a 2-dose schedule of 0,6 months in 9-14 year old females.
    To assess the humoral and the cell-mediated immune response to HPV types 16 and 18.
    To assess the reactogenicity and safety of the vaccine, and the compliance with completion of vaccination in all groups.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who the investigator believes can and will comply with the requirements of the protocol or/ and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
    A female between, and including, 9 and 25 years of age at the time of the first vaccination.
    Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form.
    Healthy subjects.
    Female subjects of non-childbearing potential may be enrolled in the study.
    Female subjects of childbearing potential may be enrolled in the study, if the subject: 1) has practiced adequate contraception for 30 days prior to vaccination, and 2) has a negative pregnancy test on the day of vaccination, and 3) has agreed to continue adequate contraception during the entire vaccination period and up to two months after the last study vaccine dose.
    E.4Principal exclusion criteria
    Pregnant or breastfeeding.
    A female planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the entire vaccination period and up to two months after the last study vaccine dose.
    Previous vaccination against HPV or planned administration of another HPV vaccine during the study.
    Child in care. (A child in care is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.)
    Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.
    Cancer or autoimmune disease under treatment.
    Planned administration/administration of a vaccine/product not foreseen by the study protocol within 30 days before each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
    Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
    Previous administration of MPL or AS04 adjuvant.
    Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
    Any confirmed or suspected immunosuppressive or immunodeficient condition.
    Family history of congenital or hereditary immunodeficiency.
    Major congenital defects or serious chronic illness.
    Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine.
    Acute disease and/or fever at the time of enrolment.
    E.5 End points
    E.5.1Primary end point(s)
    Anti-HPV-16/18 seroconversion rates and antibody titres (by ELISA) 1 month after the last dose of study vaccine, in the group (0,6) and the group (0,1,6).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month after the last dose of study vaccine (Month 7)
    E.5.2Secondary end point(s)
    Anti-HPV-16/18 seroconversion rates and antibody titres (by ELISA) in all subjects.
    Anti-HPV-16/18 antibody titres (by Pseudovirion-Based Neutralisation Assay (PBNA)) in a subset of subjects.
    Anti HPV-16/18 specific T and B cell-mediated immune responses in a sub-cohort of subjects.
    Occurrence and intensity of solicited local symptoms in all groups.
    Occurrence, intensity and relationship to vaccination of solicited general symptoms in all groups.
    Occurrence, intensity and relationship to vaccination of unsolicited symptoms in all groups.
    Occurrence of potential Immune-Mediated Diseases (pIMDs) in all groups.
    Occurrence of Medically Significant Conditions (MSCs) in all groups.
    Occurrence of Serious Adverse Events (SAEs) in all groups.
    Occurrence of SAEs related to the investigational product, to study participation, to GSK concomitant products or any fatal SAE in all groups.
    Occurrence of pregnancy and pregnancy outcomes in all groups.
    The percentage of subjects completing the vaccination schedule in all groups.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ELISA and PBNA: At Day 0 and Months 7, 12, 18, 24 and 36 (for subjects with last vaccine dose at M. 6), or at Day 0 and Months 13, 18, 24 and 36 (for subjects with last vaccine dose at Month 12).
    T and B cell-mediated immune response: At Day 0, Months 7, 12, 24 and 36 (for subjects with last vaccine dose at M. 6), or at Day 0, Months 13, 18 and 36 (for subjects with last vaccine dose at Month 12).
    Solicited symptoms: 7-day period following each vaccination.
    Unsolicited symptoms: 30-day period following each vaccination.
    pIMDs: From first vaccination to 6 months after the last vaccine dose.
    MSCs, SAEs, pregnancy: Throughout the study period.
    Completing vaccination: At Month 6 for subjects with last vaccine dose at M. 6 or at M. 12 for subjects with last vaccine dose at 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 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) 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 Yes
    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 No
    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 trial3
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Italy
    Taiwan
    Thailand
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 1095
    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: 476
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 619
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 333
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects below legal age of giving consent. Their parent(s)/ LAR(s) will give consent for them. Written informed assent will be obtained from those subjects.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state312
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 612
    F.4.2.2In the whole clinical trial 1428
    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)
    If non-inferiority of any of the 2-dose schedules versus the standard 3-dose schedule cannot be demonstrated 1 month after the last dose of study vaccine or at any further timepoint, a 3rd vaccine dose will be offered to the subjects of the respective 2-dose group at the end of the study, according to local prescribing information.
    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 Decision2011-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-13
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