EUCTR2005-003791-38-DE
Active, not recruiting
Not Applicable
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
Solvay Pharmaceuticals B.V.0 sites120 target enrollmentAugust 17, 2005
DrugsInvivac®
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prophylaxis of influenza in adults and the elderly, especially in those who run an increased risk of associated complications.
- Sponsor
- Solvay Pharmaceuticals B.V.
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Not specified
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