Prophylaxis of influenza in adults and the elderly, especially in those who run an increased risk of associated complications.
Conditions
Interventions
Trade Name: Invivac®
Product Name: Invivac®
Product Code: S206
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Influenza vaccine, (surface antigen, inactivated, virosome)
Current Sp
A/California/7/2004(H3N2)-like strain
B/Shanghai/361/2002
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 45-
Sponsors
Solvay Pharmaceuticals B.V.
Eligibility
Sex/Gender
All
Inclusion 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the immunogenicity of a commercial batch of the influenza vaccine (surface antigen, inactivated, virosome), further referred to as trivalent virosomal influenza vaccine Invivac® for the season 2005/2006, in two groups of healthy subjects: - adult subjects aged = 18 and = 60 years - elderly subjects = 61 years of age. The safety objective is to collect data on the safety and tolerability (reactogenicity and overall inconvenience) of Invivac®.;Secondary Objective: ;Primary end point(s): Serological parameters according to the Note for Guidance on Harmonization of Requirements for Influenza Vaccines (CPMP/BWP/214/96 1997), derived from the observed HI titers: - the pre and post vaccination protection rates - the proportion of subjects with seroconversion or at least a 4 fold increase in HI titer - the mean fold increase. Immunogenicity The following serological measures will be derived from the individual HI antibody titers, separately for each strain: - the pre and post vaccination protection rates, with protection defined as a HI titer =40 - the seroconversion rate, with seroconversion defined as a pre vaccination HI titer 70% > 60% proportion of subjects with a seroconversion or at least a 4 fold increase :> 40% > 30% mean fold increase :> 2.5 > 2.0 Serology will be analyzed for the efficacy sample, which is defined as the sample of all vaccinated subjects for whom both the pre and the post vaccination HI titers are available. Subjects with an intercurrent confirmed influenza infection will be excluded from the serological analysis. | — |
Countries
Germany
Outcome results
None listed