Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009

Novartis

Status and phase: Completed; Phase 2

Conditions: Interpandemic Influenza

Treatments: Biological: Seasonal Influenza Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00734734

2008-001047-19

V70P7S

Details and patient eligibility

About

Trial for annual approval of interpandemic influenza vaccines

Enrollment: 64 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 65 years of age or older
• Mentally competent
• Willing and able to give written informed consent prior to study entry
• Able to comply with all the study requirements
• In general good health

Key Exclusion Criteria:

• Any serious chronic or acute disease
• History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate);
• Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
• Receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; suspected or known HIV infection or HIV-related disease
• A bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
• Within the past 12 months, they have received more than one injection of influenza vaccine
• Within the past 6 months, participants had laboratory confirmed influenza disease; received influenza vaccine
• Within the past 4 weeks participants had received another vaccine; any investigational agent
• An acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

1

Experimental group

Treatment:

Biological: Seasonal Influenza Vaccine