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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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10 December 2019 |
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Main ID: |
EUCTR2007-006651-39-GB |
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Date of registration:
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20/01/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A phase IV, randomized, open-label, controlled, post-licensure study to evaluate the safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix®) when administered intramuscularly according to a 0, 1, 6-month schedule in females aged 18-25 years. - EPI-HPV-111103
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Scientific title:
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A phase IV, randomized, open-label, controlled, post-licensure study to evaluate the safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix®) when administered intramuscularly according to a 0, 1, 6-month schedule in females aged 18-25 years. - EPI-HPV-111103 |
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Date of first enrolment:
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22/12/2008 |
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Target sample size:
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100000 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006651-39 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria:
Female subjects who the GP or other healthcare professional believes that they can and will comply with the requirements of the protocol (e.g. willing to receive full vaccination course, available for a 24 month follow-up period) should be enrolled in the study.
A female between, and including, 18-25 years of age at the time of the first vaccination (i.e. ineligible on the subject’s 26th birthday).
Female subjects who are registered with a GP practice in Scotland.
Written informed consent obtained from the female subject.
Willing to give permission for their paper record, electronic medical records and prescribing data to be accessed and abstracted by study investigators.
Willing to be contacted and interviewed by study investigators, should the need arise for assessment of all events of interest to the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Previous vaccination against HPV or HAV.
Hypersensitivity to the active substances or to any of the excipients of the vaccines.
Suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a cold, is not a contraindication for immunization.
Pregnant or lactating female (self-reported). Subjects of childbearing potential must not be pregnant. Absence of pregnancy should be verified (e.g. urine pregnancy test) as per the investigator's clinical judgement.
Female planning to become pregnant or planning to discontinue contraceptive precautions from first dose of vaccine up to 2 months after the last dose of vaccine.
Females with confirmed diagnosis of AIDs. Females with a suspected diagnosis of an AID can be enrolled in the study if before the end of the recruitment period it is firmly established that the disease in question is not an AID.
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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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No medical condition will be investigated in this study. The study will follow vaccinated females and collect safety data focussing on autoimmune diseases, pregnancy outcomes and SAEs considered to be related to the vaccine.
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Intervention(s)
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Trade Name: Cervarix ™
Product Name: Cervarix ™
Product Code: HPV-16/18 L1 VLP AS04 vaccine
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Human Papillomavirus type 16 L1 protein
Other descriptive name: HPV-16 L1 protein
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 40-
INN or Proposed INN: Human Papillomavirus type 18 L1 protein
Other descriptive name: HPV-18 L1 protein
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 40-
Trade Name: Havrix®
Pharmaceutical Form: Suspension for injection
Other descriptive name: Hepatitis A virus antigen
Concentration unit: ELISA unit/dose enzyme-linked immunosorbent assay unit/dose
Concentration type: equal
Concentration number: 1440-
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Primary Outcome(s)
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Main Objective: To evaluate whether there is an increased incidence of neuroinflammatory AIDs or other autoimmune diseases, with onset during the theoretical risk period of 12 months (the period beginning with administration of the first dose and ending 6 months after the last dose of vaccine) in the group vaccinated with Cervarix® compared to the group vaccinated with Havrix®.
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Primary end point(s): Occurrence of validated AIDs during the theoretical risk period within the following two composite endpoints
[1] Neuroinflammatory autoimmune diseases: multiple sclerosis, transverse myelitis, optic neuritis, Guillain-Barré syndrome, demyelinating disease.
[2] Other autoimmune diseases: myasthenia gravis, autoimmune uveitis, rheumatoid arthritis, juvenile rheumatoid arthritis, reactive arthritis, ankylosing spondylitis, undifferentiated spondylarthropathy, psoriatic arthritis, cutaneous lupus, systemic lupus erythematosus, Sjögren’s syndrome, scleroderma, dermatomyositis, insulin-dependent diabetes mellitus, Grave/Basedow disease, autoimmune thyroiditis, Hashimoto thyroiditis, Addison’s disease, Crohn’s disease, ulcerative colitis, inflammatory bowel disease, Coeliac disease, antiphospholipid syndrome, autoimmune haemolytic anaemia, idiopathic thrombocytopenic purpura, pernicious anaemia, vasculitis, autoimmune glomerulonephritis, autoimmune bullous skin diseases, Steven-Johnson syndrome, psoriasis, vitiligo, Raynaud’s phenomenon, erythema nodosum, autoimmune liver diseases, autoimmune cardiomyopathy, sarcoidosis, fibromyalgia.
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Secondary Objective: To evaluate whether there is an increased incidence of systemic, organ-specific T-cell mediated, or organ specific-antibody mediated AIDs with onset during the theoretical risk period of 12 months (the period beginning with administration of the first dose and ending 6 months after the last dose of vaccine) in the group vaccinated with Cervarix® compared to the group vaccinated with Havrix®.
To assess the impact of vaccination on pregnancy measured as incidence of adverse pregnancy outcomes.
To assess the safety of the vaccines administered with regards to SAEs considered by the investigator to be possibly related to vaccination in both groups throughout the study period.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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