The purpose of this study is to assess the safety and immunogenicity (i.e. primary immune response, immunogenicity of two different doses, antibody persistence 360 days after the first vaccination, immune response to a heterologous booster given on Day 360) of a Vero cell-derived whole virus H5N1 influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
684
Two vaccinations, 21 days apart, followed by a heterologous booster vaccination on Day 360
Princess Margaret Hospital for Children
Subiaco, Australia
Frequency and severity of systemic reactions until 7 days after the first vaccination
Time frame: 7 days
Rate of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization test >= 1:20.
Time frame: 42 days
Frequency and severity of systemic and injection site reactions until 21 days after the first, second and booster vaccination
Time frame: Day 21, 42 and 381
Fever, malaise or shivering (in children and adolescents aged 3 to 17 years) and fever and irritability (in infants and young children aged 6 to 35 months) with onset within 7 days after the first, second and booster vaccination
Time frame: Day 21, 42 and 381
Adverse events observed during the entire study period
Time frame: Throughout entire study period
Antibody response associated with protection 21 days after the first and second vaccination, and again at 360 days after the first vaccination and 21 days after the booster vaccination
Antibody response defined as Hemagglutination Inhibition Antibody (HIA) titer \>= 1:40 or Single Radial Hemolysis (SRH) area \>= 25 mm2, and as measured by Microneutralization (MN) test \>= 1:20
Time frame: Day 21, 42, 360 and 381
Fold increase of antibody response 21 days after first and second vaccination as compared to baseline, and again at 21 days after the booster vaccination as compared to before the booster vaccination
Measured by MN, HI and SRH assay
Time frame: Day 21, 42, 360 and 381
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Tampere University, Espoo Vaccine Research (Tampereen Yliopisto, Espoon Rokotetutkimus)
Espoo, Finland
South Helsinki Vaccine Research Clinic (Etelä-Helsingin Rokotetutkimusklinikka)
Helsinki, Finland
Kokkola Vaccine Research Clinic (Kokkolan Rokotetutkimusklinikka)
Kokkola, Finland
Kuopion Vaccine Research Clinic
Kuopio, Finland
Oulu Vacine Research Clinic (Oulun Rokotetutkimusklinikka)
Oulu, Finland
Porin Vaccine Research Clinic
Pori, Finland
University of Tampere, Seinäjoki Vaccine Research Clinic (Tampereen Yliopisto, Seinajoen Rokotetutkimusklinikka)
Seinäjoki, Finland
Tampere Vacine Research Clinic (Tampereen Rokotetutkimusklinikka)
Tampere, Finland
Turku Vaccine Research Clinic (Turun Rokotetutkimusklinikka)
Turku, Finland
...and 10 more locations
Seroconversion 21 days after the first and second vaccination and at 21 days after the booster vaccination
Measured by MN, HI and SRH assay
Time frame: Day 21, 42 and 381