The primary objectives of the study are: * To describe the safety profile of the different formulations in all participants * To describe the hemagglutinin inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints. The secondary objectives are: * To describe antigenic coverage in each group by assessing the HAI and SN antibody responses against a panel of H3 antigens (not present in any of the vaccine formulations). * To describe SN antibody responses in each group against each of the H3 antigens. * To compare H3 HAI and SN antibody responses for the groups with quadrivalent recombinant influenza vaccine (RIV) formulations with H3 antigens to those of the quadrivalent RIV control group. * To compare the HAI and SN antibody responses for the groups with quadrivalent RIV formulation with adjuvant to the group without adjuvant.
Study duration per participant is approximately 1 year
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
210
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
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Investigational Site Number 8400003
San Diego, California, United States
Investigational Site Number 8400002
Melbourne, Florida, United States
Investigational Site Number 8400004
Orlando, Florida, United States
Investigational Site Number 8400001
Peoria, Illinois, United States
Investigational Site Number 8400005
Rockville, Maryland, United States
Number of participants with immediate adverse events
Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination
Time frame: Within 30 minutes after vaccination
Number of participants with solicited injection site or systemic reactions
Solicited injection site reactions: injection site pain, erythema, swelling, induration and bruising; solicited systemic reactions: fever, headache, malaise, and myalgia
Time frame: From Day 0 to Day 7
Number of participants with unsolicited adverse events
Unsolicited (spontaneously reported) adverse events not not fulfilling criteria for solicited reactions
Time frame: From Day 0 to Day 28
Number of participants with serious adverse events
Serious adverse events are collected throughout the study
Time frame: From Day 0 to Day 365
Number of participants with adverse events of special interest
Adverse events of special interest are collected throughout the study
Time frame: From Day 0 to Day 365
Clinical safety laboratory test results
Laboratory tests include complete blood count (CBC), platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, serum creatinine, serum lipase, and serum amylase)
Time frame: From Day 0 to Day 7
HAI and SN antibody titers against influenza antigens in the quadrivalent RIV control vaccine
Influenza antibody titers are measured by HAI and SN assays
Time frame: From Day 0 to Day 365
Individual HAI and SN titers ratio against influenza antigens in the quadrivalent RIV control vaccine
Titers ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, and Day 90/Day 0
Time frame: From Day 0 to Day 90
Number of participants with seroconversion to influenza antigens in the quadrivalent RIV control vaccine
Seroconversion is defined as HAI antibody titer \< 10 \[1/dil\] at Day 0 and post-injection titer ≥ 40 \[1/dil\] at Day 28, or titer ≥ 10 \[1/dil\] at Day 0 and a ≥ 4-fold increase in titer \[1/dil\] at Day 28)
Time frame: From Day 0 to Day 28
HAI Ab titer ≥ 40 [1/dil]
Influenza vaccine antibody titers are measured by HAI assay
Time frame: From Day 0 to Day 365
2-fold and 4-fold increase in SN titers
Influenza vaccine antibody titers are measured by SN assay
Time frame: From Day 0 to Day 28
HAI antibody titers against influenza H3 antigens not present in the vaccine formulations and the SN antibody titers against each of the H3 antigens
Influenza vaccine antibody titers are measured by HAI and SN assays
Time frame: Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365
Individual HAI titer ratios against influenza H3 antigens not present in the vaccine formulations and individual SN titer ratio against each of the H3 antigens
Titer ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, Day 90/Day 0
Time frame: From Day 0 to Day 90
Number of participants with seroconversion to influenza H3 antigens not present in the vaccine formulations
Seroconversion is defined as HAI antibody titer \< 10 \[1/dil\] at Day 0 and post-injection titer ≥ 40 \[1/dil\] at Day 28, or titer ≥ 10 \[1/dil\] at Day 0 and a ≥ 4-fold increase in titer \[1/dil\] at Day 28)
Time frame: Day 0 and Day 28
2-fold and 4-fold rise in SN antibody titers against each of the H3 antigens
Influenza vaccine antibody titers a are measured by SN assay
Time frame: Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365
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