Annual Study to Investigate Inactivated Subunit Influenza Vaccine for the 2006/2007 Influenza Season in Europe.

Study Overview
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Brief Summary
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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).

Official Title
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Immunogenicity and Reactogenicity of Trivalent Influenza Subunit Vaccine Influvac® for the Season 2006/2007. An Open, Baseline-Controlled Study in Two Groups of Healthy Subjects: Adults and Elderly.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Biological: Influvac® subunit influenza vaccine for i.m./deep s.c.injection


Participation Criteria
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Eligibility Criteria
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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 documented serious systemic 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. Exclusion criteria only for female subjects aged >=18 and <=60 years and of childbearing potential: Pregnancy (positive urine pregnancy test on Day 1) or breastfeeding. Absence of use of a medically accepted method of birth control (i.e. oral contraceptive, Intra Uterine Device, double barrier method).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Influvac® subunit influenza vaccine for i.m./deep s.c.injection|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2006/2007 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Vaccine, CHMP criteria