The primary objectives of the study are: * To describe the safety profile of the different quadrivalent recombinant influenza vaccine (RIV) formulations. * To describe the hemagglutination inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (HA) (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints. The secondary objectives of the study 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 HAI and SN antibody responses in each group against each of the H3 antigens. * To compare the HAI and SN antibody responses for the groups with different H3 antigens to the control group.
Study duration per participant is approximately 90 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular
Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular
Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular
Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular
Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular
Research Centers of America Site Number : 8400002
Hollywood, Florida, United States
Rochester Clinical Research, Inc. Site Number : 8400001
Rochester, New York, United States
Coastal Carolina Research Center Site Number : 8400003
North Charleston, South Carolina, 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 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 90
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 90
HAI antibody titers against HA influenza antigens in quadrivalent RIV control group
Influenza vaccine antigens are measured by HAI assay
Time frame: From Day 0 to Day 90
Individual ratio of HAI titers against HA influenza antigens in quadrivalent RIV control group
Titers ratio are calculated for Day 8/Day 0 and Day 28/Day 0, Day 56/Day 28 and Day 90/Day 28
Time frame: From Day 0 to Day 90
Number of participants with seroconversion to HA influenza antigens in quadrivalent RIV control group
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 28
Number of participants with HAI antibody titer ≥ 40 [1/dil] against HA influenza antigens in quadrivalent RIV control group
Influenza vaccine antigens are measured by HAI assay
Time frame: From Day 0 to Day 90
2-fold and 4-fold increase in SN antibody titers against HA influenza antigens in quadrivalent RIV control group
Time frame: From Day 0 to Day 90
HAI and SN antibody titers against influenza H3 antigens
Time frame: From Day 0 to Day 90
Individual ratio of HAI and SN titers against influenza H3 antigens
Titers ratio are calculated for Day 8/Day 0 and Day 28/Day 0, Day 56/Day 28 and Day 90/Day 28
Time frame: From Day 0 to Day 90
Number of participants with seroconversion to influenza H3 antigens
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 28
Number of participants with HAI antibody titer ≥ 40 [1/dil] against influenza H3 antigens
Time frame: From Day 0 to Day 90
2-fold and 4-fold increase in SN antibody titers against influenza H3 antigens
Time frame: From Day 0 to Day 90
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