Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to Elderly Subjects

NCT ID: NCT00522236

Last Updated: 2012-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2007-07-31

Brief Summary

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008

Intervention Type: BIOLOGICAL

A single 0.5mL dose of Novartis adjuvanted subunit influenza vaccine, Fluad contained 45μg of viral hemagglutinin, composed of 15μg of the three influenza antigens:

• A(H1N1) strain: IVR-145 (Solomon Island/3/2006 - like strain)
• A(H3N2) strain: NYMC X-161B (A/Wisconsin/67/2005-like strain)
• B strain: (B/Malaysia/2506/2004-like strain) in accordance with the recommendations of the World Health Organization, the EU and the national Regulatory Agencies for the 2007/2008 season.

The vaccine is a milky liquid, and was packaged in ready to use, single dose syringes.

A single dose of FLUAD vaccine was administered intramuscularly, preferably in the deltoid muscle of the non dominant arm.

Interventions

Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008

A single 0.5mL dose of Novartis adjuvanted subunit influenza vaccine, Fluad contained 45μg of viral hemagglutinin, composed of 15μg of the three influenza antigens:

• A(H1N1) strain: IVR-145 (Solomon Island/3/2006 - like strain)
• A(H3N2) strain: NYMC X-161B (A/Wisconsin/67/2005-like strain)
• B strain: (B/Malaysia/2506/2004-like strain) in accordance with the recommendations of the World Health Organization, the EU and the national Regulatory Agencies for the 2007/2008 season.

The vaccine is a milky liquid, and was packaged in ready to use, single dose syringes.

A single dose of FLUAD vaccine was administered intramuscularly, preferably in the deltoid muscle of the non dominant arm.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 65 years of age or older

Exclusion Criteria

• any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or insulin-dependent diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
• hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin or any other component of the vaccine
• history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
• known or suspected (or high risk of developing) impairment/alteration of immune function
• any acute disease or infections requiring systemic antibiotic or antiviral therapy within the past 7 days
• fever within the past 3 days

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

Dipartimento di Medicina e Scienze dell'Invecchiamento

Chieti, , Italy

Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, Via S. Spaventa, 37

Lanciano, , Italy

Countries

Italy

Other Identifiers

2007-000966-19

Identifier Type: -

Identifier Source: secondary_id

V70P5S

Identifier Type: -

Identifier Source: org_study_id