The goal of the study is to assess the safety and immune response after vaccination with different doses and vaccination schedules of virosomal influenza vaccine.
Virosomal influenza vaccine is usually administered intramuscularly as a single 0.5 mL dose. The aim of this study is to evaluate the safety and immunogenicity of different doses and vaccination schedules. A total of 84 healthy adults aged 18-50 years will be randomized (1:1:1) into 3 treatment groups: subjects of group 1 will receive a standard dose (0.5 mL) at Days 1, 29, and 57; subjects of group 2 will receive a double dose (1.0 mL) at Day 1 and a standard dose (0.5 mL) at Day 57; subjects of group 3 will receive a triple dose (0.5 mL) at Day 1. Local and systemic solicited adverse events up to Day 4 after each vaccination will be documented. To assess the subjects' humoral and cellular immune response against homologous and heterologous virus strains, blood will be drawn from each participant at baseline (Day 1), at the 4 subsequent monthly visits (Months 1 to 4) and at Month 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
84
Virosomal influenza vaccine with the recommended vaccine composition for season 2011-2012: * 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus * 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus * 15 μg HA antigen of B/Brisbane/60/2008-like virus Intramuscular (i.m.) administration (M. deltoideus or M. vastus lateralis)
Center for the Evaluation of Vaccination, Unit of Epidemiology and Social Medicine, University of Antwerp
Antwerp, Belgium
Incidence of local and systemic solicited adverse events
Time frame: 4 days after each vaccination (day of vaccination and the followoing 3 days)
Incidence of unsolicited AEs
Time frame: 4 weeks after each vaccination
Humoral and cellular immune response against homologous and heterologous vaccine strains
Time frame: Baseline (before vacination) and Months 1, 2, 3, 4, and 12 after vaccination
Incidence of SAEs
Time frame: up to 12 months after baseline
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