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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.

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ClinicalTrials.gov Identifier: NCT00522067
Recruitment Status : Completed
First Posted : August 29, 2007
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Brief Summary:
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 or disease Intervention/treatment Phase
Influenza Disease Biological: Adjuvanted influenza vaccine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2007
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1
FLUAD
Biological: Adjuvanted influenza vaccine
Vaccination with MF 59 adjuvanted trivalent seasonal influenza vaccine



Primary Outcome Measures :
  1. 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
  2. To evaluate the safety of the administration of a single intramuscular(IM) injection of an inactivated, adjuvanted influenza vaccine, in at risk adult subjects.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522067


Locations
Italy
Azienda Sanitaria USL 7 di Siena
Siena, Italy, 53100
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines

Additional Information:
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00522067     History of Changes
Other Study ID Numbers: V70P4
2007-000964-26
First Posted: August 29, 2007    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: January 2012

Keywords provided by Novartis ( Novartis Vaccines ):
influenza
influenza vaccine
adjuvanted influenza vaccine
subunit influenza vaccine
surface antigen

Additional relevant MeSH terms:
Influenza, Human
Chronic Disease
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Vaccines
Immunologic Factors
Physiological Effects of Drugs