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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: |
EUCTR2007-002104-18-FR |
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Date of registration:
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23/07/2007 |
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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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Evaluation of the Cellular, Humoral and Mucosal Immune Response in Adults and Elderly Subjects Vaccinated either with an Inactivated Influenza Vaccine Administered via the Intradermal Route or an Inactivated Influenza Vaccine Administered via the Intramuscular Route
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Scientific title:
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Evaluation of the Cellular, Humoral and Mucosal Immune Response in Adults and Elderly Subjects Vaccinated either with an Inactivated Influenza Vaccine Administered via the Intradermal Route or an Inactivated Influenza Vaccine Administered via the Intramuscular Route |
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Date of first enrolment:
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27/08/2007 |
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Target sample size:
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160 |
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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:2007-002104-18 |
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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): 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 40 years (adults) or 60 to 85 years (elderly)
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 4 weeks after vaccination
5) Entitlement 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
2) Breast-feeding woman
3) Participation in another clinical trial investigating a vaccine, drug, medical device or a medical procedure in the 4 weeks preceding the trial vaccination
4) Planned participation in another clinical trial during the present trial period
5) 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
6) Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
7) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
8) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
9) Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
10) Receipt of any vaccine in the 4 weeks preceding the trial vaccination
11) Planned receipt of any vaccine in the 4 weeks following the trial vaccination
12) Known Human Immunodeficiency Virus, Hepatitis B or Hepatitis C seropositivity
13) Previous vaccination against Influenza in the previous 6 months
14) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding the inclusion contraindicating IM vaccination
15) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
16) Febrile illness (oral temperature =37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
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 adult subjects aged 18 to 40 years and elderly subjects aged 60 to 85 years with an inactivated, split-virion influenza vaccine administered via the intradermal route using Vaxigrip® as IM reference vaccine
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Intervention(s)
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Product Name: Intradermal Influenza Vaccine
Product Code: 333
Pharmaceutical Form: Suspension for injection
Other descriptive name: Inactivated, split-virion, influenza virus (H3N2 strain)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 90-
Other descriptive name: Inactivated, split-virion, influenza virus (H1N1 strain)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 90-
Other descriptive name: Inactivated, split-virion, influenza virus (B strain)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 90-
Product Name: Intradermal Influenza Vaccine
Product Code: 333
Pharmaceutical Form: Suspension for injection
Other descriptive name: Inactivated, split-virion, influenza virus (H3N2 strain)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 150-
Other descriptive name: Inactivated, split-virion, influenza virus (H1N1 strain)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 150-
Other descriptive name: Inactivated, split-virion, influenza virus (B strain)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 150-
Trade Name: VAXIGRIP
Pharmaceutical Form: Suspension for injection
Other descriptive name: Inactivated, split-virion, influenza virus (H3N2 strain)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration number: 30-
Other descriptive name: Inactivated, split-virion, influenza virus (H1N1 strain)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: not less then
Concentration n
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Primary Outcome(s)
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Main Objective: - To describe the cellular immune response per age group (adults or elderly) and vaccine group (ID influenza or IM comparator vaccines) before vaccination, and, 7 days, 10 days, 14 days, 21 days, 180 days after vaccination
- To describe the humoral immune response per age group and vaccine group before vaccination, 14 days, 21 days, and 180 days after vaccination
- To describe mucosal immunity per age group and vaccine group through quantification of influenza-specific IgA (total, specific and sub-classes: IgA1 and IgA2) collected from saliva and serum before vaccination and 10 days, 14 days, 21 days and 180 days after vaccination
- To describe the safety of the vaccines per age group and per vaccine group after vaccination
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Primary end point(s): Cellular Immune Response
- Intracellular Cytokine Staining (ICS):
-- To quantify the number of Interferon- ? (INF-?), Interleukine-2 (IL-2) or Tumor necrosis factor- a (TNF-a) secreting CD4+ and CD8+ T lymphocytes after stimulation with influenza live virus (for each vaccine strain) in all the subjects at D0, D7, D10, D14, D21 and D180
-- To quantify the number of influenza-specific CD4+ and CD8+ T lymphocytes displaying a memory profile (IL-2 secreting cells [IL-2+]) in all the subjects at D0, D7, D10, D14, D21 and D180
-- To quantify the number of influenza-specific CD4+ and CD8+ T lymphocytes exhibiting an effector profile (INF-? and TNF-a secreting cells [INF-?+ and TNF-a+]) in all the subjects at D0, D7, D10, D14, D21 and D180
- Cytometric Bead Array (CBA):
-- To measure the concentration of a panel of Th1 (IFN-?, TNF-a, IL-2), and Th2 (IL-5, IL-4, IL 10) cytokines secreted by peripheral blood mononuclear cells (PBMCs) upon in vitro re stimulation with the three influenza vaccine strains in all the subjects at D0 and at the peak of the cellular response measured by ICS (D7 or D10 or D14 or D21 or D180)
- Lymphoproliferation:
-- To quantify the specific lymphoproliferative response (measured by 3H-thymidine incorporated in cells and expressed in counts per minute [cpm]), upon in vitro re-stimulation of PBMCs (= Stimulation Index [SI]) with influenza antigens from the three vaccine strains in all the subjects at D0 and at the peak of the cellular response measured by ICS (D7 or D10 or D14 or D21 or D180)
Depending on the results obtained with ICS method, CBA and lymphoproliferation assessments will not be performed at each timepoint: if a peak of response is clearly identified for one of the timepoints tested, CBA and lymphoproliferatrion methods will be performed at this timepoint only. If no peak of response emerged, CBA and lymphoproliferatrion method will be performed at the most relevant timepoint obtained according to results and literature.
Humoral Immune Response
The humoral immune response will be evaluated in all subjects using the hemagglutination inhibition (HI) test. Anti-hemagglutinin (HA) antibody titers for the three strains will be measured before vaccination and at 14, 21, and 180 days after vaccination.
The endpoints per strain will be:
-- Anti-HA individual titer on D0, D14, D21 and D180
-- Individual titers ratio:, D14/D0, D21/D0 and D180/D0
-- Seroconversion status (subjects with a pre-vaccination titer < 10 [1/dil], post-vaccination titer =40 [1/dil] on D14, D21 and D180), or significant increase of post-vaccination titer (subjects with a pre-vaccination titer =10 [1/dil], post-vaccination titer = 4-fold increase versus pre- vaccination titer on D14, D21 and D180)
--Seroprotection status: titer =40 (1/dil) on D14, D21 and D180
Seroprotection and seroconversion will be described using the criteria of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
Mucosal Immunity
Total IgA, specific IgA, IgA1 and IgA2, each from saliva and serum, will be measured using Enzyme-Like Immunsorbent Assay (ELISA) before vaccination and 10, 14, 21, and 180 days after vaccination.
The endpoints will be:
-- Individual titer - for saliva and serum - for Total IgA, Specific IgA, IgA1 and IgA2 on D0, D10, D14, D21 and D180
-- Individual titer ratio - for saliva and serum - for Total IgA, Specific IgA, IgA1 and IgA2 on D10/D0, D14/D0, D21/D0 and D180/D0
Individual titer ratio - for saliva and serum - Specific IgA / Total IgA on D0, D10, D14, D21 and D180
Safety
The endpoints will be:
-- Occurrence, nature (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), duration, severity, and relationship to vaccination of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after vaccination
-- Occurrence of the reactions (MedDRA Preferred Terms) as per the Committee for
Human Medicinal Products (CHMP) NfG CPMP/BWP/214/96 in the 3 days
following vaccination.
-- Occurrence, time to onset, number of days of occurrence, and severity of solicited (prelisted in the subject’s diary card (DC) and the Case Report Form [CRF]) injection site and systemic reactions up to 7 days after vaccination
-- Occurrence, nature (MedDRA preferred term), time to onset, duration, severity, and relationship to vaccination (for systemic AEs only) of unsolicited (spontaneously reported) AEs up to 21 days after vaccination
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Secondary Objective:
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 12/07/2007
Contact:
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