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    Summary
    EudraCT Number:2020-001169-34
    Sponsor's Protocol Code Number:HPV_Elimination
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-01
    Trial 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 ConcernedSweden - MPA
    A.2EudraCT number2020-001169-34
    A.3Full title of the trial
    Concomitant HPV vaccination and HPV screening for rapid elimination of HPV infection and cervical cancer in Sweden
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Women aged 23-25 that are invited and participating in the organised cervical screening program of Sweden will be offered 2 doses of Gardasil 9 at their first and second visit, with 3 years apart. This in line with WHO's directives to eliminate cervical cancer worldwide.
    A.3.2Name or abbreviated title of the trial where available
    HPV Elimination
    A.4.1Sponsor's protocol code numberHPV_Elimination
    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 SponsorRegion Stockholm
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRegion Stockholm
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegion Stockholm
    B.5.2Functional name of contact pointPrinciple Investigator
    B.5.3 Address:
    B.5.3.1Street AddressKarolinska University Hospital, F56, Clinical Pathology & Cytology
    B.5.3.2Town/ cityHuddinge
    B.5.3.3Post codeSE-14186
    B.5.3.4CountrySweden
    B.5.4Telephone number46724682460
    B.5.6E-mailjoakim.dillner@sll.se
    B.Sponsor: 2
    B.1.1Name of SponsorRegion Stockholm
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRegion Stockholm
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegion Stockholm
    B.5.2Functional name of contact pointPI of HPV Elimination
    B.5.3 Address:
    B.5.3.1Street AddressKarolinska University Hospital in Huddinge, F56, Clinical Pathology & Cytology
    B.5.3.2Town/ cityHuddinge
    B.5.3.3Post codeSE-14186
    B.5.3.4CountrySweden
    B.5.4Telephone number+46724682460
    B.5.6E-mailjoakim.dillner@sll.se
    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 Gardasil 9
    D.2.1.1.2Name of the Marketing Authorisation holderMSD
    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.3.1Product nameGardasil 9
    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 INNHUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB22592
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB22591
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
    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 microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
    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 microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB130868
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    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 INNHUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB130869
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    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 INNHUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB130870
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    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 INNHUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB130871
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    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 INNHUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN
    D.3.9.4EV Substance CodeSUB130872
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HPV infection and related diseases, such as cervical intraepithelial neoplasia grade 2 and 3 and cervical cancer.
    E.1.1.1Medical condition in easily understood language
    Cervical cellular changes and tumour in the cervix.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008229
    E.1.2Term Cervical cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10056576
    E.1.2Term Cervical intraepithelial neoplasia
    E.1.2System Organ Class 100000004872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study aims to evaluate whether organised, concomitant HPV vaccination and HPV screening offered by the Swedish cervical screening program to all resident women aged 23-25 will result in a more rapid elimination of HPV infection in Sweden. This objective will be examined at the population level.
    E.2.2Secondary objectives of the trial
    The study will evaluate whether the addition of concomitant vaccination to the cervical screening program results in an improved efficiency and/or safety of the cervical screening program:

    1) Protection of Gardasil 9 against HPV infection and against CIN2+ by Gardasil 9 HPV vaccine types. The effectiveness of one-dose vaccination, and to determine the effect of 2-dose vaccinations.

    2) Efficiency will be measured by the yield of histopathologically confirmed high-grade cervical cancer precursors or cancer (cervical intraepithelial neoplasia grade 2, 3, or cervical cancer) in relation to the consumption of resources and convenience for the women.

    3) Safety will be measured by evaluating the occurrence of obstetrical complications such as preterm births as well as by measuring the number of excised cervical specimens found to be histopathologically benign.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible women will include resident women within the age range of 23-25 due for invitation to organised cervical cancer screening who consent to participate in the study.
    E.4Principal exclusion criteria
    1. Known history of severe allergic reaction or hypersensitivty to any of the components of the HPV vaccine.
    o For GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80 or Sodium borate
    2. Known history of immune-related disorders
    3. Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection or low-grade fever.
    4. Administration of immunoglobulin or blood-derived products within 6 months prior to scheduled HPV vaccine first dose
    5. Current pregnancy (reported)
    6. Hysterectomized women
    E.5 End points
    E.5.1Primary end point(s)
    Prevalence of HPV infection in Sweden
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of the study
    E.5.2Secondary end point(s)
    Histopathologically confirmed high-grade cervical cancer precursors or cancer (cervical intraepithelial neoplasia grade 2, 3, or cervical cancer) (CIN2+), by HPV type in the lesion.
    Consumption of resources.
    Number of screening and healthcare visits.
    Obstetrical complications, in particular preterm births.
    Excised cervical specimens found to be benign.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of the study
    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 No
    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
    Drug uptake
    Adherence to drug administration schedule
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned11
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150000
    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 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 2021-02-01. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state150000
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Region Blekinge
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Region Dalarna
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Region Gotland
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Region Gävleborg
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation Region Halland
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation Region Jämtland Härjedalen
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation Region Jönköpings län
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 8
    G.4.1Name of Organisation Region Kalmar län
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 9
    G.4.1Name of Organisation Region Kronoberg
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 10
    G.4.1Name of Organisation Region Norrbotten
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 11
    G.4.1Name of Organisation Region Skåne
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 12
    G.4.1Name of Organisation Region Stockholm
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 13
    G.4.1Name of Organisation Region Sörmland
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 14
    G.4.1Name of Organisation Region Uppsala
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 15
    G.4.1Name of Organisation Region Värmland
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 16
    G.4.1Name of Organisation Region Västerbotten
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 17
    G.4.1Name of Organisation Region Västernorrland
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 18
    G.4.1Name of Organisation Region Västmanland
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 19
    G.4.1Name of Organisation Region Örebro län
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 20
    G.4.1Name of Organisation Region Östergötland
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 21
    G.4.1Name of Organisation Västra Götalandsregionen
    G.4.3.4Network Country Sweden
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-24
    P. End of Trial
    P.End of Trial StatusOngoing
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