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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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25 November 2019 |
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Main ID: |
EUCTR2006-000671-15-GB |
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Date of registration:
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10/04/2006 |
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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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Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2006-2007 Formulation (Intramuscular Route) - N/A
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Scientific title:
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Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2006-2007 Formulation (Intramuscular Route) - N/A |
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Date of first enrolment:
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04/05/2006 |
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Target sample size:
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120 |
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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:2006-000671-15 |
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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: no
Randomised: no
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
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): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1) Aged at least 18 years on the day of inclusion
2) Informed consent form signed
3) Able to attend all scheduled visits and to comply with all trial procedures
4) For a woman, inability to bear a child or negative urine pregnancy test at V01
5) For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least three weeks after vaccination.
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:
1) Febrile illness (oral temperature =37.5°C) on the day of vaccination
2) Breast-feeding
3) Participation in another clinical trial in the four weeks preceding the trial vaccination
4) Planned participation in another clinical trial during the present trial period
5) Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
6) Systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
7) Chronic illness at a stage that could interfere with trial conduct or completion
8) Current abuse of alcohol or drug addiction that may interfere with the subject’s ability to comply with trial procedures
9) Blood or blood-derived products received in the past three months
10) Any vaccination in the four weeks preceding the trial vaccination
11) Vaccination planned in the three weeks following the trial vaccination
12) Previous vaccination against influenza in the previous 6 months
13) Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
14) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Vaccination of healthy subjects aged 18 to 60 years (60 subjects) and over the 60 years (60 subjects) with one dose of the new formulation of the influenza vaccine for the 2006-2007 Northern Hemisphere season.
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Intervention(s)
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Trade Name: Inactivated Influenza Vaccine (split virion) BP
Product Name: Inactivated, split virion Influenza Vaccine
Product Code: 314
Pharmaceutical Form: Suspension for injection
Other descriptive name: Inactivated, split virion, Influenza Vaccine (A/H1N1 strain)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Other descriptive name: Inactivated, split virion, Influenza Vaccine (A/H3N2 strain)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Other descriptive name: Inactivated, split virion, Influenza Vaccine (B strain)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
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Primary Outcome(s)
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Main Objective: To check the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere 2006-2007 formulation with the requirements of the European Medicines Agency (EMEA) Note for Guidance (NfG) CPMP/BWP/214/96.
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Primary end point(s): For each vaccine strain:
- Individual anti-Hemagglutinin (HA) antibody titers ratio D21/D0,·
- Seroprotection status: titer =40 (1/dil) on D0 and D21,
- Seroconversion for subjects with a titer <10 (1/dil) on D0: post-injection titer =40 (1/dil) on D21 or significant increase for subjects with a titer =10 (1/dil) on D0: =4-fold increase of post-injection titer on D21.
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Secondary Objective: To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere 2006-2007 formulation.
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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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