Back to resultsSafety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Elderly Subjects
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Surface Antigen, Inactivated, (Adjuvanted with MF59C.1), form. 2006-07
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Adjuvanted Influenza Vaccine
Eligibility Criteria
Inclusion Criteria: 65 years of age or older Exclusion Criteria: any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated 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 polymyxin 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 within the past 7 days any acute disease or infections requiring systemic antibiotic or antiviral therapy fever within the past 3 days
Sites / Locations
- Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
- Ufficio Igiene e Sanità Pubblica di Lanciano, Via S. Spaventa, 37
Outcomes
Primary Outcome Measures
CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT00329927
First Posted
May 23, 2006
Last Updated
September 13, 2006
Sponsor
Novartis
Collaborators
Novartis Vaccines
1. Study Identification
Unique Protocol Identification Number
NCT00329927
Brief Title
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Elderly Subjects
Official Title
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Commercially Available Surface Antigen, Inactivated, (Adjuvanted With MF59C.1) Influenza Vaccine, Formulation 2006-2007, When Administered to Elderly Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines
4. Oversight
5. Study Description
Brief Summary
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Adjuvanted Influenza Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Surface Antigen, Inactivated, (Adjuvanted with MF59C.1), form. 2006-07
Primary Outcome Measure Information:
Title
CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
Secondary Outcome Measure Information:
Title
Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
Title
Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
Title
Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria:
65 years of age or older
Exclusion Criteria:
any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated 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 polymyxin 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 within the past 7 days
any acute disease or infections requiring systemic antibiotic or antiviral therapy fever within the past 3 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines - Drug Information Services
Organizational Affiliation
Novartis Vaccines & Diagnostics
Official's Role
Study Chair
Facility Information:
Facility Name
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
City
Via dei Vestini
State/Province
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Ufficio Igiene e Sanità Pubblica di Lanciano, Via S. Spaventa, 37
City
Lanciano
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Elderly Subjects
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