Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1, Seasonal Influenza Vaccine, Formulation 2009-2010

Novartis

Status and phase: Completed; Phase 2

Conditions: Seasonal Influenza

Treatments: Biological: Seasonal Influenza Vaccine (MF59C.1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00956761

V70_09S

2009-010586-23

Details and patient eligibility

About

This is a trial for annual registration of the updated seasonal influenza vaccine formulation.

Enrollment: 63 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Subjects of 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 disease
• History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
• A proven hypersensitivity to any component of the study vaccine
• Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
• Bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
• Within the past 12 months, participants had received more than one injection of influenza vaccine
• Within the past 6 months, participants had laboratory confirmed influenza disease or received influenza vaccine

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

1

Experimental group

Treatment:

Biological: Seasonal Influenza Vaccine (MF59C.1)