Immunogenicity and reactogenicity of the trivalent influenza subunit vaccine Influvac® for the season 2006/2007. An open, baseline-controlled study in two groups of healthy subjects: adult subjects greater than or equal to 18 and less than or equal 60 years and elderly subjects greater than or equal to 61 years of age. - Influvac annual update 2006

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

• Registration Number: EUCTR2006-001300-37-DE
• Lead Sponsor: Solvay Pharmaceuticals B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Signed and dated informed consent.
2. Healthy and aged =18 and = 60 years or = 61 years of age.
3. Mental health 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

1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
2. Having fever and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways.
3. Having experienced a documented serious systemic reaction after previous influenza vaccination.
4. 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.
5. 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:
6. Pregnancy (positive urine pregnancy test on Day 1) or breastfeeding.
7. Absence of use of a medically accepted method of birth control (i.e. oral contraceptive, Intra Uterine Device, double barrier method).
The rationale for the above exclusion criteria 1 and 3 is that of safety; exclusion criteria 2, 4 and 5 are necessary for eligibility, as they prevent interference with this study’s primary objective (immunogenicity against hemagglutinin of the specified strains of influenza ; also see section 7.8); and although allowed as per label, exclusion criteria 6 and 7 are standard for these clinical studies due to administrative reasons.

Study & Design

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