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 Spon
A/H3N2:like strain
B:like strain as recommended by WHO
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 45-
Sponsors
Solvay Pharmaceuticals B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent. 2. Healthy subjects 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
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 greater than or equal to 18 and less than or equal to 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, inclusion criteria 6 and 7 are standard for these clinical studies due to administrative reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The Primary Objective: To determine the immunogenicity of the trivalent virosomal influenza vaccine Invivac® for the season 2006/2007, in two groups of healthy subjects: - adult subjects aged greater than or equal to 18 and less than or equal to 60 years - elderly subjects greater than or equal to 61 years of age. The Safety Objective: To collect data on the safety and tolerability (reactogenicity and overall inconvenience) of Invivac® for the season 2006/2007.;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: -pre and post vaccination protection rates -the proportion of subjects with seroconversion or at least a 4 fold increase in HI titer -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 40 -the proportion of subjects with at least a 4 fold increase in HI titer, i.e. the proportion of subjects with a pre vaccination HI titer>10 and a post vaccination relative increase of >4 fold -the proportion of subjects with seroconversion or at least a 4 fold increase in HI titer -the mean fold increase, which is the geometric mean of the intra-individual increases (i.e. post vaccination HI titer/pre vaccination HI titer). The results of the serological analysis will be evaluated according to the CHMP Note for Guidance which requires that for both age groups at least one of the following criteria is met for each of the three strains: Criterion adult elderly proportion of subjects achieving a HI titer >40 | — |
Countries
Germany
Outcome results
None listed