Healthy female and male elderly subjects where influenza vaccination is suggested MedDRA version: 14.1 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: INFLEXAL V*1SIR C/A 2010-2011
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INFLUENZA VACCINE (SURFACE ANTIGEN, INACTIVATED, VIROSOME)
Concentration unit: µg microgram(s
Sponsors
CRUCELL SWITZERLAND AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy female and male adults aged >60 years on the day of enrollment; Written informed consent; Females with confirmed menopause (postmenopausal is defined as 12 months with no menses without an alternative medical cause). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease; Acute febrile illness (=38.0 °C); Prior vaccination with an influenza vaccine for season 2011/2012; Known hypersensitivity to any vaccine component; Previous history of a serious adverse reaction to influenza vaccine; History of egg protein allergy or severe atopy; Known blood coagulation disorder; Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of =0.5 mg/kg/day prednisolone or equivalent (inhaled or topical steroids are allowed); Known immunodeficiency (including leukemia, HIV seropositivity) or cancer; Investigational medicinal product received in the past 3 months (90 days); Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days); Participation in another clinical trial; Employee at the investigational site or relative of the investigator; Anticipated non-compliance with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the humoral immune response 3 weeks after vaccination with Inflexal V according to the CHMP criteria in elderly subjects for the current WHO recommended strains;Secondary Objective: To evaluate immunogenicity parameters 6 months after vaccination; To evaluate the cell mediated immune response 3 weeks after influenza vaccination versus baseline; To assess the cross-protection against selected A/H1N1 heterogenous influenza circulating strains 3 weeks after influenza vaccination versus baseline; To assess the safety and tolerability of the 2011/2012-season influenza vaccine Inflexal V.;Primary end point(s): Immunogenicity parameters for hemagglutination inhibition (HI) antibody titers for the 3 vaccine strains 21 days after vaccination according to CHMP criteria. The immunogenicity parameters will be assessed according to the CHMP 'Note for guidance on harmonisation of requirements for influenza vaccines', 1997. Assessments will be done with the HI test in serum (all subjects) against all the 3 strains included in the seasonal vaccine. To confirm immunogenicity, at least one of the following CHMP criteria has to be met for each strain: Seroconversion rate: defined as a =4-fold increase in HI antibody titer and a titer of =1:40 to be reached in >30% of subjects; Seroprotection rate: defined as an HI antibody titer =1:40 to be reached in >60% of subjects; Geometric mean titer (GMT): defined as >2.0-fold increase in the GMT of HI antibodies.;Timepoint(s) of evaluation of this end point: 21 days after the vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity parameters for HI antibody titers for the 3 vaccine strains 6 months after vaccination according to CHMP criteria. The immune response against the A/H1N1 vaccine strain and 4 selected circulating heterogeneous A/H1N1 influenza strains will be assessed with the HI test as well with the microneutralization method to measure the neutralizing influenza antibodies 3 weeks after vaccination versus baseline. A microneutralization and HI titre of 1:40 or more will be considered protective; Cellular immunity will be evaluated for the first 30 enrolled subjects. The following 2 types of cytokines for two influenza strains (the A/H1N1 vaccine strain and one A/H1N1 heterogeneous strain) will be evaluated for cellular immunity 3 weeks after vaccination versus baseline in order to test the impact of vaccination on T-lymphocyte proliferation: o influenza specific IFN gamma production o influenza specific IL-2 production; Solicited local and systemic adverse events (AEs); Unsolicited AEs; Tolerability and acceptability.;Timepoint(s) of evaluation of this end point: Immunogenicity test: 6 months after the vaccination. Cross-reactivity:3 weeks and 6 months (for the 3 vaccine strains only)after vaccination cellular immunity: 3 weeks after the vaccination. | — |
Countries
Italy
Contacts
Public ContactServizio Info Sperimentazione
Crucell Italy s.r.l
Outcome results
None listed