Clinical trial NCT01229371: Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Suppliers
Official title: Randomized, Parallel-group, Double-blind Multi-center Phase III Study to Assess the Immunogenicity and Safety of the 2010/2011-season Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Suppliers, in Elderly and Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Virus
Vaccination
Immunisation
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2010-10-27
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Immunogenicity - Geometric Mean Titer Fold Increase From Baseline
timeFrame: 3 weeks after vaccination (Day 22 ± 2 days)
measure: Immunogenicity - Seroprotection Rate
timeFrame: 3 weeks after vaccination (Day 22 ± 2 days)
measure: Immunogenicity - Seroconversion Rate
timeFrame: 3 weeks after vaccination (Day 22 ± 2 days)
Secondary outcomes:
measure: Number of Participants With Local and Systemic Adverse Events
timeFrame: Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)
Other outcomes:
Locations:
city: Allschwil
country: Switzerland
facility: Covance Clinical Research Unit AG
city: Arzo
country: Switzerland
facility: Cross Research S.A. Phase I Unit
Study officials:
affiliation: Covance Clinical Research Unit AG
name: Michael Seiberling, MD
role: PRINCIPAL_INVESTIGATOR
References: