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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00522236
First received: August 28, 2007
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Influenza
Biological: Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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) [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD® vaccine (formulation 2007/2008) in elderly subjects (≥ 65 years). [ Time Frame: 3 days, respectively 21 days post-vaccination ] [ Designated as safety issue: Yes ]

    Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.

    Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.

    Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).



Enrollment: 56
Study Start Date: June 2007
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Biological: 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.


  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522236

Locations
Italy
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, 66034
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00522236     History of Changes
Other Study ID Numbers: V70P5S, 2007-000966-19
Study First Received: August 28, 2007
Last Updated: January 24, 2012
Health Authority: Italy: Ministero Della Salute, EMEA

Keywords provided by Novartis:
Adjuvanted Influenza Vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014