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Support Annual Strain Update, Safety and Immunogenicity of an Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Subjects 18-64 Years Affected by Chronic Diseases.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00522067
First received: August 28, 2007
Last updated: January 2, 2012
Last verified: January 2012
History of Changes
  Purpose

This phase II, open label, is designed as a seasonal study to support annual strain update evaluating the safety, clinical tolerability and immunogenicity of the 2007-2008 formulation of Novartis Vaccines' adjuvanted, subunit influenza vaccine in adults with underlying chronic diseases


Condition Intervention Phase
Influenza Disease
 Biological: Adjuvanted influenza vaccine
 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 Support Annual Strain Update and to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Subjects Aged 18-64 Years Affected by Chronic Diseases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Evaluate the antibody response to each flu vacc. antigen, measured by SRH at 21-day post-vacc. in at risk adults in compliance with the requirements of the EU recommendations for the evaluation of the immunog. for a new formulation of a licensed flu vacc
  • To evaluate the safety of the administration of a single intramuscular(IM) injection of an inactivated, adjuvanted influenza vaccine, in at risk adult subjects.

Enrollment: 52
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
FLUAD
 Biological: Adjuvanted influenza vaccine
Vaccination with MF 59 adjuvanted trivalent seasonal influenza vaccine

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 64 years of age adult volunteers, mentally competent, willing and able to give written informed consent prior to study entry, suffering from at least one of these chronic diseases: hypertension, heart disease, chronic obstructive pulmonary disease (COPD) or asthma, hepatic or renal insufficiency, arteriosclerotic disease or insulin dependent diabetes mellitus

Exclusion Criteria:

  • Hypersensitivity to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate or any other component of the vaccine;
  • History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
  • Known or suspected impairment/ alteration of immune function;
  • Having received within the past 12 months more than one injection of influenza vaccine
  • Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522067

Locations
Italy
Azienda Sanitaria USL 7 di Siena
Siena, Italy, 53100
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: NCT00522067     History of Changes
Other Study ID Numbers: V70P4, 2007-000964-26
Study First Received: August 28, 2007
Last Updated: January 2, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Novartis:
influenza
influenza vaccine
adjuvanted influenza vaccine
subunit influenza vaccine
surface antigen

Additional relevant MeSH terms:
Chronic Disease
Influenza, Human
Disease Attributes
Pathologic Processes
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013