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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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21 December 2021 |
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Main ID: |
EUCTR2007-004347-30-HU |
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Date of registration:
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17/10/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A phase IIIb, randomized, open, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine co-administered with GlaxoSmithKline Biologicals’ inactivated hepatitis A and hepatitis B vaccine adsorbed (Twinrix® Paediatric) in healthy female subjects aged 9–15 years. - HPV-029 PRI
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Scientific title:
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A phase IIIb, randomized, open, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine co-administered with GlaxoSmithKline Biologicals’ inactivated hepatitis A and hepatitis B vaccine adsorbed (Twinrix® Paediatric) in healthy female subjects aged 9–15 years. - HPV-029 PRI |
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Date of first enrolment:
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20/02/2008 |
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Target sample size:
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810 |
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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:2007-004347-30 |
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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: no
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): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Denmark
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Hungary
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
All subjects must satisfy the following criteria at study entry:
• Subjects who the investigator believes that they and/or their legally acceptable representatives (LARs) can and will comply with the requirements of the protocol should be enrolled in the study.
• A female between, and including, 9 and 15 years of age at the time of the first vaccination.
• Written informed consent obtained from subject's LAR and written informed assent obtained from the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects must not be pregnant. Absence of pregnancy should be verified with a urine pregnancy test.
• Subjects must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy or be pre-menarcheal, or if the subject is of childbearing potential, she must be abstinent or use adequate contraception for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche (begin menstruating) during the study, and therefore become of childbearing potential, must agree to follow the same precautions.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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:
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
• 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.
• 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 (pharmaceutical product or device).
• Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine(s).
• A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
• Pregnant or breastfeeding women.
• Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
• Previous administration of MPL or AS04 adjuvant.
• Previous vaccination against hepatitis A or B or planned administration of any hepatitis A or B vaccine other than that foreseen by the study protocol during the study period.
• History of hepatitis A or B infection.
• Known exposure to hepatitis A or B within the previous 6 weeks.
• Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
• Cancer or autoimmune disease under treatment.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines (e.g. aluminium, MPL).
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Acute disease at the time of enrolment.
• 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. Enrolment will be postponed until the subject is outside the specified window.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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For active immunization of females from the age of 10 years onwards for the prevention of cervical cancer by protecting against incident and 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.
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Intervention(s)
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Trade Name: Cervarix
Product Code: HPV-16/18 L1 VLP AS04 vaccine
Pharmaceutical Form: Suspension for injection
Other descriptive name: HPV-16 L1 VLP antigen
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 40-
Other descriptive name: HPV-18 L1 VLP antigen
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 40-
Trade Name: Twinrix Paediatric
Product Name: Twinrix Paediatric
Pharmaceutical Form: Suspension for injection
Other descriptive name: Hepatitis A virus (inactivated)
Concentration unit: ELISA unit/ml enzyme-linked immunosorbent assay unit/millitre
Concentration type: equal
Concentration number: 720-
Other descriptive name: Hepatitis B surface antigen
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 20-
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Primary Outcome(s)
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Main Objective: • To demonstrate non-inferiority of the hepatitis A immune response when HAB is co-administered with HPV-16/18 vaccine at Month 0, 1 and 6 compared to when HAB is administered alone at Month 0, 1 and 6.
• To demonstrate non-inferiority of the hepatitis B immune response in terms of proportion of subjects who are seroprotected for anti-HBs at Month 7 when HAB is co-administered with HPV-16/18 vaccine at Month 0, 1 and 6 compared to when HAB is administered alone at Month 0, 1 and 6.
• To demonstrate non-inferiority of the HPV-16/18 immune response at Month 7 when the HPV-16/18 vaccine is co-administered with HAB compared to when the HPV-16/18 vaccine is administered alone.
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Secondary Objective: • To evaluate at Month 7, in all HAB vaccine recipients, the immune response against hepatitis B with respect to seroconversion rates and GMTs.
• To evaluate at Month 7 the immune response against HPV-16 and HPV-18 in subjects aged 9 years who received HPV vaccine with or without concomitant administration of HAB.
• To evaluate the incidence and intensity of solicited local and general symptoms during the 7-day period, and unsolicited adverse events during the 30-day period following vaccination in all vaccine groups, overall in subjects aged 9-15 years and in subjects aged 9 years.
• To assess the safety of the study vaccine with respect to the nature, intensity and relationship to vaccination of serious adverse events, and the occurrence of medically significant conditions, in all groups throughout the study period in all groups.
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Primary end point(s): • Anti-HAV seroconversion status at Month 7 in the HPV+HAB group and the HAB group.
• Anti-HAV antibody titres at Month 7 in the HPV+HAB group and the HAB group.
• Anti-HBs seroprotection status at Month 7 in the HPV+HAB group and the HAB group.
• Anti-HPV-16/18 seroconversion status at Month 7 in the HPV group and the HPV+HAB group.
• Anti-HPV-16/18 antibody titres at Month 7 in the HPV group and the HPV+HAB group.
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Secondary ID(s)
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2007-004347-30-SE
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110886
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 06/02/2008
Contact:
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