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

Condition(s) targeted: Influenza

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

Phase: Phase 3

Status: Completed

Sponsored by: Crucell Holland BV

Official(s) and/or principal investigator(s):
Michael Seiberling, MD, Principal Investigator, Affiliation: Covance Clinical Research Unit AG

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome:

Immunogenicity - Geometric Mean Titer Fold Increase From Baseline

Immunogenicity - Seroprotection Rate

Immunogenicity - Seroconversion Rate

Secondary outcome: Number of Participants With Local and Systemic Adverse Events

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Covance Clinical Research Unit AG, Allschwil 4123, Switzerland

Cross Research S.A. Phase I Unit, Arzo 6864, Switzerland

Starting date: October 2010
Last updated: August 29, 2013