Immunogenicity and reactogenicity of the trivalent virosomal influenza vaccine Invivac® for the season 2005/2006. An open, baseline controlled study in twogroups of healthy subjects: adult subjects aged = 18 and =60 years and elderly subjects = 61 years of age.(Extension to protocol S206.3.010) - Invivac

• Conditions: Prophylaxis of influenza in adults and the elderly, especially in those who run an increased risk of associated complications.

• Registration Number: EUCTR2005-003791-38-DE
• Lead Sponsor: Solvay Pharmaceuticals B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

-Signed and dated informed consent
-Healthy subjects aged = 18 and = 60 years or = 61 years of age
-The mental health of the subject must be good enough to understand the study and the informed consent form and to fill in the questionnaire.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 (RA, SLE, auto-immune thyroid disorders), taking immunosuppressive medication (such as corticosteroids) 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:
-Pregnancy (positive urine pregnancy test on Day 1) or breastfeeding
-For women of childbearing potential: absence of use of a medically accepted method of birth control (i.e. oral contraceptive, Intra Uterine Device, double barrier method).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified