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

NCT ID: NCT00345462

Last Updated: 2010-02-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30

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 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).

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Trivalent virosomal influenza vaccine

Intervention Type: BIOLOGICAL

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 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.

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Solvay Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

Site 1

Berlin, , Germany

Countries

Germany

Other Identifiers

2006-001301-28

Identifier Type: -

Identifier Source: secondary_id

S206.3.012

Identifier Type: -

Identifier Source: org_study_id