Prophylaxis of influenza. MedDRA version: 9.1 Level: HLT Classification code 10022005 Term: Influenza viral infections
Conditions
Interventions
Trade Name: Influvac® 2007/2008
Product Name: Influvac
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Influenza vaccine (surface antigen, inactivated)
Current Sponsor code: S.201.3
Sponsors
Solvay Pharmaceuticals B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the immunogenicity of the trivalent influenza subunit vaccine Influvac® for the season 2007/2008, in two groups of healthy subjects: adults aged greater than or equal to 18 years and less than or equal to 60 years and elderly greater than 61 years of age. The safety objective is to collect data on the safety and tolerability (reactogenicity and overall inconvenience) of Influvac®.;Secondary Objective: None;Primary end point(s): Immunogenicity is a well-correlated and long time accepted surrogate parameter for clinical effectiveness of influenza vaccines. Therefore, the primary efficacy variable will be HI titers and its derived parameters as defined by the CHMP guideline for influenza vaccines. The following serological parameters will be derived from the individual HI antibody titers, separately for each strain: - The pre and post vaccination seroprotection rates, with seroprotection defined as an HI titer greater than or equal to 40 - The seroconversion rate, with seroconversion defined as a pre vaccination HI titer 70% > 60% seroconversion / 4-fold increase rate: > 40% > 30% mean fold increase: > 2.5 > 2.0 | — |
Countries
Germany
Outcome results
None listed