Study FBP00005 is planned to be a translational Phase I, randomized, modified double-blind, active-controlled, multi-center study to be conducted in 2 stages in approximately 400 adults, 18 to 49 years of age and ≥ 60 years of age, in Australia. The purpose of the study is to evaluate the safety and immunogenicity of an influenza vaccine formulation composed of the WHO-recommended virus strains plus an additional H3 strain, compared to formulations containing a single strain from each influenza virus subtype. Younger adults 18 to 49 years of age will be enrolled in Stage 1 and offered study vaccine formulations at the standard dose. Adults ≥ 60 years of age in Stage 2 will be offered study vaccine formulations at a higher dose. Enrollment of participants in Stage 2 will occur after review of, and be guided by, safety and immunogenicity results from Stage 1. The study duration will be approximately 3 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
400
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Investigational Site Number : 0360002
Botany, New South Wales, Australia
Investigational Site Number : 0360010
Brookvale, New South Wales, Australia
Investigational Site Number : 0360012
Maroubra, New South Wales, Australia
Investigational Site Number : 0360011
Miranda, New South Wales, Australia
Investigational Site Number : 0360004
Sippy Downs, Queensland, Australia
Investigational Site Number : 0360003
Southport, Queensland, Australia
Investigational Site Number : 0360013
Taringa, Queensland, Australia
Investigational Site Number : 0360007
Adelaide, South Australia, Australia
Investigational Site Number : 0360001
Melbourne, Victoria, Australia
Investigational Site Number : 0360005
Morayfield, Australia
Number of participants with immediate adverse event
Includes unsolicited systemic adverse events (or) medically relevant unsolicited systemic adverse events, including those related to the product administered
Time frame: Within 30 minutes after vaccination
Number of participants with solicited injection site reactions
Adverse reactions prelisted in the participant diary
Time frame: Within 7 days after vaccination
Number of participants with solicited systemic reactions
Adverse reactions prelisted in the participant diary
Time frame: Within 7 days after vaccination
Number of participants with unsolicited adverse events
Adverse events other than solicited reactions
Time frame: Throughout the study, approximately 3 weeks
Number of participants with serious adverse events
SAEs occurring throughout the study
Time frame: Throughout the study, approximately 3 weeks
Number of participants with adverse events of special interest (AESIs)
AESIs occurring throughout the study
Time frame: Throughout the study, approximately 3 weeks
Seroconversion based on hemagglutination inhibition antibody titer
Seroconversion (HAI Ab titer \< 10 \[1/dilution\] at day 1 and post-injection titer ≥ 40 \[1/dilution\] at day 22, or titer ≥ 10 \[1/dilution\] at day 1 and a ≥ 4-fold increase in titer \[1/dilution\] at day 22)
Time frame: Day 1 and day 22
Seroprotection based on hemagglutination inhibition antibody titer
Seroprotection (HAI Ab titer ≥ 40 \[1/dilution\])
Time frame: Day 1 and day 22
Obtained hemagglutination inhibition antibody titers
Assessment of hemagglutination inhibition (HAI) antibody (Ab) titers obtained on day 1 and day 22 after vaccination
Time frame: Day 1 and day 22
Obtained virus neutralization antibody titers
Assessment of virus neutralization (VN) antibody (Ab) titers obtained on day 1 and day 22 after vaccination
Time frame: Day 1 and day 22
Individual hemagglutination inhibition titers ratio
Seroconversion (HAI Ab titer \< 10 \[1/dilution\] at day 1 and post-injection titer ≥ 40 \[1/dilution\] at day 22, or titer ≥ 10 \[1/dilution\] at day 1 and a ≥ 4-fold increase in titer \[1/dilution\] at day 22)
Time frame: Day 1 and day 22
Individual virus neutralization titers ratio
Individual VN titers ratio (day 22/ day 1)
Time frame: Day 1 and day 22
2-fold rise in virus neutralization titers
Time frame: From day 1 to day 22
4-fold rise in virus neutralization titers
Time frame: From day 1 to day 22
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