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

Solvay

Status and phase

Withdrawn

Phase 3

Conditions

Healthy Volunteers

Treatments

Biological: Trivalent virosomal influenza vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00345462

S206.3.012

2006-001301-28

Details and patient eligibility

About

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 virosomal vaccine (Invivac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Invivac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza virosomal vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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).