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Main
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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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4 April 2022 |
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Main ID: |
EUCTR2009-009977-85-FR |
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Date of registration:
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03/04/2009 |
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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 Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation (Intradermal Route) - Immunogenicity and Safety of a Vaccine Against Influenza (2009-2010 Northern Hemisphere Season)
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Scientific title:
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Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation (Intradermal Route) - Immunogenicity and Safety of a Vaccine Against Influenza (2009-2010 Northern Hemisphere Season) |
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Date of first enrolment:
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19/05/2009 |
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Target sample size:
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130 |
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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:2009-009977-85 |
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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:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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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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France
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1) Aged 18 to 59 years (i.e. to the day before the 60th birthday) or 60 years or older (from the day of the 60th birthday) on the day of inclusion
2) Provision of a signed informed consent
3) Able to attend all scheduled visits and comply with all trial procedures
4) For a woman of child-bearing potential: avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 3 weeks after vaccination
5) Entitled to national social security
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) For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at V01
2) Febrile illness (temperature =38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
3) Breast-feeding woman
4) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
5) Planned participation in another clinical trial during the present trial period
6) Known or suspected 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
7) Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances
8) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
9) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
10) Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
11) Receipt of any vaccine in the 4 weeks preceding the trial vaccination
12) Planned receipt of any vaccine in the 3 weeks following the trial vaccination
13) Previous vaccination against influenza in the previous 6 months
14) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion
15) Known Human Immunodeficiency Virus (HIV), HBs antigen or Hepatitis C seropositivity
16) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
17) Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
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 adults up to 59 years of age and elderly of 60 years of age and over with inactivated split-virion influenza vaccine administered by the intradermal route
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Intervention(s)
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Trade Name: INTANZA
Product Name: Intradermal Influenza Vaccine 9µg
Pharmaceutical Form: Suspension for injection
Other descriptive name: Influenza virus (split virion, inactivated) A/Brisbane/59/2007 (H1N1)-like virus
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 90-
Other descriptive name: Influenza virus (split virion, inactivated) A/Brisbane/10/2007 (H3N2)-like virus
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 90-
Other descriptive name: Influenza virus (split virion, inactivated) B/Brisbane/60/2008-like virus
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 90-
Trade Name: INTANZA
Product Name: Intradermal Influenza Vaccine 15µg
Pharmaceutical Form: Suspension for injection
Other descriptive name: Influenza virus (split virion, inactivated) A/Brisbane/59/2007 (H1N1)-like virus
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 150-
Other descriptive name: Influenza virus (split virion, inactivated) A/Brisbane/10/2007 (H3N2)-like virus
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 150-
Other descriptive name: Influenza virus (split virion, inactivated) B/Brisbane/60/2008-like virus
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 150-
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Primary Outcome(s)
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Primary end point(s): Immunogenicity will be evaluated before and 21 days after injection of the ID influenza vaccine using the Hemagglutination Inhibition (HAI) technique. For each vaccine strain, anti-Hemagglutinin (HA) antibody titers will be expressed as HAI titers obtained in duplicate on D0 and D21, summarized at the subject level by individual geometric mean of duplicates on D0 and D21.
The derived endpoints will be:
• Individual titer 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
Safety will be evaluated within 21 days following injection of the ID influenza vaccine, NH 2009-2010 formulation in subjects aged 18 to 59 years and in subjects aged 60 years or older.
• The occurrence of the following reactions during the first 3 days following vaccination will be more specifically reported (as defined by the CPMP NfG CPMP/BWP/214/96):
• Injection site induration =5 cm for more than 3 days
• Injection site ecchymosis
• Temperature >38°C for 24 hours or more
• Malaise
• Shivering
• Occurrence of unsolicited AE reported in the 30 minutes after vaccination
• Occurrence of solicited (prelisted in the subject diary and Case Report Form [CRF]) injection site reactions and systemic reactions within 7 days following vaccination
• Occurrence of unsolicited (spontaneously reported) AEs within 21 days following vaccination,
• Occurrence of SAEs from V01 up to the end of the trial
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Secondary Objective: Not applicable
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Main Objective: In subjects aged 18 to 59 years for the ID influenza vaccine 9 µg and in subjects aged 60 years or older for the ID influenza vaccine 15 µg:
1) To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the ID influenza vaccine Northern Hemisphere (NH) 2009-2010 formulation with the requirements of the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96.
2) To describe the safety of the corresponding strength of the ID influenza vaccine, NH 2009-2010 formulation.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 19/05/2009
Contact:
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