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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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7 September 2021 |
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Main ID: |
EUCTR2006-001281-16-ES |
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Date of registration:
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22/03/2006 |
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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 III, observer-blind, randomised study to evaluate the safety and immunogenicity of one and two administrations of pandemic monovalent (H5N1) influenza vaccine (split virus formulation containing 15 µg HA and adjuvanted with AS03) in adults aged 18 years and older - H5N1-008, H5N1-011 EXT 008 Day 180
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Scientific title:
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A phase III, observer-blind, randomised study to evaluate the safety and immunogenicity of one and two administrations of pandemic monovalent (H5N1) influenza vaccine (split virus formulation containing 15 µg HA and adjuvanted with AS03) in adults aged 18 years and older - H5N1-008, H5N1-011 EXT 008 Day 180 |
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Date of first enrolment:
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20/04/2006 |
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Target sample size:
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5052 |
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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:2006-001281-16 |
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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: no
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: observer-blind
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
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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Estonia
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Germany
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Spain
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
•Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
•A male or female aged 18 years or above at the time of the first vaccination.
•Written informed consent obtained from the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•If the subject is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
•Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination.
•Administration of interpandemic influenza vaccine between Day 0 and Day 51of the study. Those study participants belonging to risk groups eligible to receive the annual inderpandemic influenza vaccine (in accordance with local regulations) can receive the annual vaccination after day 51 and before the end of the study on Day 180.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•History of chronic alcohol consumption and/or drug abuse.
•History of hypersensivity to vaccines.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
•Major congenital defects or serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included).
•Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever (defined as axillary temperature >37.5°C)).
•Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or during the study.
•lactating women
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Immunization against (H5N1) influenza disease in subjects aged 18 years and older.
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Intervention(s)
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Product Name: Influenza Monovalent Split Virus (H5N1) vaccine adjuvanted with AS03
Product Code: H5N1-008
Pharmaceutical Form: Suspension for injection
Other descriptive name: HA from A/Vietnam/1194/2004 (H5N1) NIBRG-14
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 15-
Trade Name: Fluarix
Product Name: Fluarix
Pharmaceutical Form: Suspension for injection
Other descriptive name: HA from A/New Caledonia/20/99
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Other descriptive name: HA from A/New York/55/2004
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Other descriptive name: HA from B/Malaysia/2506/2004
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Intramuscular use
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Primary Outcome(s)
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Main Objective: The primary objective is to evaluate the safety/reactogenicity of the pandemic influenza vaccine in terms of :
•solicited local/general symptoms during 7 days post-vaccination,
•unsolicited symptoms during 21 days following the first vaccination and 30 days following the second one
•serious adverse events during the entire study period (180 days).
•Occurrence of new onset chronic diseases during the entire study period in each group.
•Occurrence of medically significant conditions prompting emergency room visits or physician visits that are not related to common diseases or routine visits, during the entire study period in each group
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Primary end point(s): For safety/reactogenicity evaluation:
•Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms during a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after each dose of vaccine and overall.
•Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during 21 days following the first vaccination (i.e. day of first vaccination and 20 subsequent days) and during 30 days following the second vaccination (i.e. day of second vaccination and 29 subsequent days).
•Occurrence of serious adverse events during the entire study period.
•Occurrence of new onset chronic diseases during the entire period in each group.
•Occurrence of medically significant conditions prompting emergency room visits or physician visits that are not related to common diseases or routine visits, during the entire study period in each group.
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Secondary Objective: •To evaluate the immunogenicity of the pandemic influenza vaccine in terms of the humoral immune response (anti-haemagglutinin antibody and neutralizing antibody) 21 days after each vaccination.
•To assess the persistence of antibodies 180 days after the first vaccination
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Secondary ID(s)
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107064, 107217
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2006-001281-16-SE
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 10/04/2006
Contact:
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