This Phase 3 study is a randomized, observer-blind immunogenicity and safety study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,044
Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1
Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio of Hemagglutination Inhibition (HI) Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Time frame: Day 22
Immunogenicity Endpoint: Seroconversion Rate (SCR) and SCR Difference for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
The SCR defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination (Day 22) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer. The SCR difference is defined as the Comparator QIV SCR minus the aQIV SCR.
Time frame: Day 1 to Day 22
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 22 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Time frame: Day 22
Immunogenicity Endpoint: GMT and GMT Ratio of HI Antibodies at Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
The GMT ratio is defined as the geometric mean of the postvaccination HI titer for Comparator QIV over the geometric mean of the postvaccination HI titer for aQIV.
Time frame: Day 181
Immunogenicity Endpoint: GMT of HI Antibodies on Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
GMTs on Day 1 (prior to vaccination), Day 22 (3 weeks after vaccination), and Day 181 (6 months after vaccination) as determined by HI assay against each of the four vaccine strains
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84013 Coastal Clinical Research, Inc.
Mobile, Alabama, United States
84007 Alliance for Multispecialty Research
Tempe, Arizona, United States
84005 JEM Research Institute
Atlantis, Florida, United States
84010 Headlands Research Orlando
Orlando, Florida, United States
84001 Meridian Clinical Research
Savannah, Georgia, United States
84003 Meridian Clinical Research
Sioux City, Iowa, United States
84006 Alliance for Multispecialty Research
Kansas City, Missouri, United States
84009 Meridian Clinical Research
Lincoln, Nebraska, United States
84002 Meridian Clinical Research
Norfolk, Nebraska, United States
84004 Meridian Clinical Research
Omaha, Nebraska, United States
...and 19 more locations
Time frame: Day 1 to Day 181
Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) for Day 22/Day 1 and Day 181/Day 1 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
The GMFI is defined as the geometric mean of the fold increase of postvaccination HI titer over the prevaccination HI titer.
Time frame: Day 1 to Day 181
Immunogenicity Endpoint: The Percentage of Subjects With a Titer ≥1:40 at Day 1, Day 22, and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
Percentage of subjects with a titer ≥1:40 on Day 1, Day 22, and Day 181 as determined by HI assay against each of the four vaccine strains
Time frame: Day 1 to Day 181
Immunogenicity Endpoint: SCR at Day 22 and Day 181 for the A/H1N1, A/H3N2, B/Yamagata, and B/Victoria Vaccine Strains
The SCR defined as the percentage of subjects with either a prevaccination HI titer \<1:10 and a postvaccination (Day 22 or Day 181) HI titer ≥1:40, or with either a prevaccination HI titer ≥1:10 and a ≥4-fold increase in postvaccination HI titer.
Time frame: Day 1 to Day 181
Safety Endpoint: Solicited Local and Systemic AEs for 7 Days Following Vaccination
Number and percentage of subjects with solicited local and systemic AEs occurring for 7 days following vaccination
Time frame: Day 1 through Day 7
Safety Endpoint: All Unsolicited AEs for 21 Days Following Vaccination
The percentage of subjects with at least one unsolicited AE occurring 21 days following vaccination The severity of AEs is based on the maximum severity associated with a Preferred Term for a reported AE. Related AEs include possibly related AEs, probably related AEs and AEs with missing relatedness assessment. The severity and relatedness of AEs were determined by the investigator. For the any AE summary by severity, a subject with multiple AEs is counted according to the highest severity of their reported AEs.
Time frame: Day 1 through Day 22
Safety Endpoint: Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Withdrawal From the Study, and Adverse Events of Special Interest (AESIs)
The percentage of subjects with any SAE, AE leading to withdrawal, or AESI during the study period
Time frame: Day 1 through Day 271