Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Suppliers

Crucell

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Inflexal V influenza vaccine (AdImmune HA antigen) 2010/2011; Biological: Inflexal V influenza vaccine (CSL HA Antigen) 2010

Study type: Interventional

Funder types: Industry

Identifiers

NCT01229371

ADD-V-A001

Details and patient eligibility

About

The purpose of this study is to assess the humoral immune response and safety of the parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V using two different HA antigen suppliers (AdImmune and CSL), in groups of young and elderly adults, using the EMA (European Medicines Agency) regulation as a guideline.

Full description

The objectives of this study are to evaluate the humoral immunogenicity and safety of the parenteral formulation of the 2010/2011-season influenza vaccine, Inflexal V, using HA antigen obtained from 2 different production facilities, and to compare the immunogenicity of both formulations to pre-defined EMA criteria for the annual relicensing of seasonal influenza vaccines. The evaluation will be done in young adults and elderly.

Enrollment: 440 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy female and male adults
• Aged ≥18 years on Day 1
• Written informed consent

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 (including the H1N1 pandemic swine flu vaccine) in the past 330 days
• 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, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
• Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)
• 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)
• Pregnancy or lactation
• Participation in another clinical trial
• Employee at the investigational site, or spouse and children of the investigator, or relative living in the same household as the investigator and/or are dependent on the investigator
• Suspected non-compliance

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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440 participants in 4 patient groups

Subjects ≥18 to ≤60 Years - CSL HA Antigen

Active Comparator group

Description:

Inflexal V influenza vaccine (CSL HA Antigen) 2010 Group A will be vaccinated with Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using CSL HA Antigen) 2010/2011 containing per 0.5 mL i.m. dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

Treatment:

Biological: Inflexal V influenza vaccine (CSL HA Antigen) 2010

Subjects >60 Years - CSL HA Antigen

Active Comparator group

Description:

Inflexal V influenza vaccine (CSL HA Antigen) 2010 Group B will be vaccinated with Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using CSL HA Antigen) 2010/2011 containing per 0.5 mL i.m. dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

Treatment:

Biological: Inflexal V influenza vaccine (CSL HA Antigen) 2010

Subjects ≥18 to ≤60 Years - AdImmune HA Antigen

Experimental group

Description:

Inflexal V influenza vaccine (AdImmune HA Antigen) 2010/2011 Group C will be vaccinated with Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA antigen) 2010/2011 containing per 0.5 mL i.m.dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

Treatment:

Biological: Inflexal V influenza vaccine (AdImmune HA antigen) 2010/2011

Subjects >60 Years - AdImmune HA Antigen

Experimental group

Description:

Inflexal V influenza vaccine (AdImmune HA Antigen) 2010/2011 Group D will be vaccinated with Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA antigen) 2010/2011 containing per 0.5 mL i.m.dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus

Treatment:

Biological: Inflexal V influenza vaccine (AdImmune HA antigen) 2010/2011