Back to resultsAnnual Study to Investigate Influenza Vaccine Due to New Virus Strains for the 2007/2008 Influenza Season in Europe
Primary Purpose
Healthy Volunteers
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Trivalent influenza subunit vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Healthy Volunteers focused on measuring Influenza, Vaccine, CHMP criteria
Eligibility Criteria
Inclusion Criteria:
- Signed and dated informed consent.
- Healthy and aged >= 18 and <= 60 years or >= 61 years of age.
- Mental health good enough to understand the study and the informed consent form and to fill in the questionnaire.
Exclusion Criteria:
- Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
- Having fever and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways.
- Having experienced a serious systemic and/or local reaction after previous influenza vaccination.
- Having an auto-immune disorder (e.g. RA, SLE, auto-immune thyroid disorders) or other disorders affecting the immune system, taking immunosuppressive medication (such as systemic corticosteroids) including the four weeks preceding the start of the study (date of informed consent), or having a disease in a terminal stage.
- Having received vaccination against influenza within the previous six months before Visit 1.
Sites / Locations
- Site 1
- Site 2
Outcomes
Primary Outcome Measures
Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2007/2008
Secondary Outcome Measures
HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00479921
Brief Title
Annual Study to Investigate Influenza Vaccine Due to New Virus Strains for the 2007/2008 Influenza Season in Europe
Official Title
Immunogenicity and Reactogenicity of Trivalent Influenza Subunit Vaccine Influvac® for the Season 2007/2008. An Open, Baseline-Controlled Multi-Center Study in Two Groups of Healthy Subjects: Adults and Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Solvay Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
Influenza, Vaccine, CHMP criteria
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Trivalent influenza subunit vaccine
Primary Outcome Measure Information:
Title
Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2007/2008
Secondary Outcome Measure Information:
Title
HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Signed and dated informed consent.
Healthy and aged >= 18 and <= 60 years or >= 61 years of age.
Mental health good enough to understand the study and the informed consent form and to fill in the questionnaire.
Exclusion Criteria:
Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
Having fever and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways.
Having experienced a serious systemic and/or local reaction after previous influenza vaccination.
Having an auto-immune disorder (e.g. RA, SLE, auto-immune thyroid disorders) or other disorders affecting the immune system, taking immunosuppressive medication (such as systemic corticosteroids) including the four weeks preceding the start of the study (date of informed consent), or having a disease in a terminal stage.
Having received vaccination against influenza within the previous six months before Visit 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 1
City
Tessenderlo
Country
Belgium
Facility Name
Site 2
City
Hamburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Annual Study to Investigate Influenza Vaccine Due to New Virus Strains for the 2007/2008 Influenza Season in Europe
We'll reach out to this number within 24 hrs