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

NCT00522236 | Completed Phase 2

• 2 other identifiers: V70P5S2007-000966-19
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

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

Keywords

Adjuvanted Influenza Vaccine

Outcome Measures

Primary Outcomes (1)

• Antibody response to each influenza vaccine antigen as measured by Single Radial Hemolysis in elderly subjects (≥65y) in compliance with the requirements of the current EU recommendations for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96)

  The measures of immunogenicity for each antigen are: * the geometric mean area (GMA) on Day 0 and Day 21 * the Day 21/Day 0 geometric mean area ratio (GMR) * the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2 * the percentage of subjects achieving an SRH area ≥ 25 mm2 on Day 0 and Day 21 1. Seroconversion is defined as negative prevaccination serum/postvaccination serum area ≥ 25 mm2. 2. Significant increase in antibody titer is defined as at least a 50% increase in area.

  21 days post-vaccination

Secondary Outcomes (1)

• To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD® vaccine (formulation 2007/2008) in elderly subjects (≥ 65 years).

  3 days, respectively 21 days post-vaccination

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Interventions

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

Arm 1

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• \- 65 years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (2)

Dipartimento di Medicina e Scienze dell'Invecchiamento

Chieti, Italy

Location

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

Lanciano, 66034, Italy

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Antigens, Surface

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2007
• First Posted: August 29, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: January 25, 2012

Record last verified: 2012-01

Locations

IT (2)