Back to resultsSupport 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.
Primary Purpose
Influenza Disease
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Adjuvanted influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza Disease focused on measuring influenza, influenza vaccine, adjuvanted influenza vaccine, subunit influenza vaccine, surface antigen
Eligibility 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
Sites / Locations
- Azienda Sanitaria USL 7 di Siena
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
FLUAD
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00522067
Brief Title
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.
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 Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Disease
Keywords
influenza, influenza vaccine, adjuvanted influenza vaccine, subunit influenza vaccine, surface antigen
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
FLUAD
Intervention Type
Biological
Intervention Name(s)
Adjuvanted influenza vaccine
Intervention Description
Vaccination with MF 59 adjuvanted trivalent seasonal influenza vaccine
Primary Outcome Measure Information:
Title
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
Title
To evaluate the safety of the administration of a single intramuscular(IM) injection of an inactivated, adjuvanted influenza vaccine, in at risk adult subjects.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
Azienda Sanitaria USL 7 di Siena
City
Siena
ZIP/Postal Code
53100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
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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