Immunogenicity and reactogenicity of the trivalent influenza subunit vaccine Influvac® for the season 2007/2008. An open, baseline-controlled multi-centre study in two groups of healthy subjects: Adult subjects aged greater than or equal to 18 and less than or equal to 60 years and elderly subjects greater than 61 years of age. - Influvac Annual Update 2007/2008

• Conditions: Prophylaxis of influenza.; MedDRA version: 9.1Level: HLTClassification code 10022005Term: Influenza viral infections

• Registration Number: EUCTR2007-000875-40-DE
• Lead Sponsor: Solvay Pharmaceuticals B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-24
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

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

Inclusion Criteria

1. Signed and dated informed consent.
2. Healthy and aged greater than or equal to 18 and less than or equal to 60 years or greater than or equal to 61 years of age.
3. Mental health 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 serious systemic and/or local 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.
6. Being confined by order of either judicial or administrative authorities.

Exclusion criteria only for female subjects aged greater than or equal to 18 and less than or equal to 60 years and of childbearing potential:

7. Pregnancy (positive urine pregnancy test on Day 1) or breastfeeding.
8. 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