The purpose of this study is to evaluate Immunogenicity and Safety of a High-Dose (HD) Influenza Vaccine (IV) in Adults 50 through 64 Years of Age.
The study duration will be approximately 180 days (+ 14 days).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,180
Liquid suspension for intramuscular injection
Liquid suspension for intramuscular injection
CenExel CNS- Site Number : 8400005
Geometric mean titers (GMTs) against influenza vaccine antibodies (Ab)
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage.
Time frame: Day 1 and Day 29
Percentage of participants with seroconversion for influenza vaccine antibodies
Anti-influenza antibodies will be measured using HAI assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage. Seroconversion status 28 days after vaccination (ie, preinjection Ab titer \< 10 \[1/dil\] at Day 1 and post-injection Ab titer≥ 40 \[1/dil\] at Day 29 or preinjection Ab titer ≥ 10 \[1/dil\] at Day 1 and a ≥ 4-fold increase in titer \[1/dil\] at Day 29).
Time frame: Day 29
Geometric Mean of Individual Titer Ratio (GMTR)
GMTRs will be measured using HAI assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage. Individual HAI antibody titer ratio Day 29/Day 1.
Time frame: Day 1 and Day 29
Percentage of participants with detectable HAI titer (HAI titer ≥ 10 [1/dil])
Anti-influenza antibodies will be measured using HAI assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage. Percentage of participants with HAI antibody titer \>=10 (1/dil)
Time frame: Day 1 and Day 29
Percentage of participants with HAI titer ≥ 40 (1/dil)
Anti-influenza antibodies will be measured using HAI assay for 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria lineage. Percentage of participants with HAI antibody titers ≥ 40 (1/dil)
Time frame: Day 29
Number of participants with immediate adverse events (AEs)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Los Alamitos, California, United States
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400019
Fort Myers, Florida, United States
Research Centers of America - Hollywood- Site Number : 8400010
Hollywood, Florida, United States
IACT Health - Columbus - Talbotton Road- Site Number : 8400011
Columbus, Georgia, United States
Cenexel IRA - iResearch Atlanta- Site Number : 8400007
Decatur, Georgia, United States
The Hope Clinic of Emory Vaccine Center- Site Number : 8400017
Decatur, Georgia, United States
Centricity Research - Rincon- Site Number : 8400012
Rincon, Georgia, United States
Cenexel IRS - iResearch Savannah- Site Number : 8400008
Savannah, Georgia, United States
Alliance for Multispeciality Research - Newton- Site Number : 8400003
Newton, Kansas, United States
Alliance for Multispeciality Research - Lexington- Site Number : 8400002
Lexington, Kentucky, United States
...and 10 more locations
Immediate events are recorded to capture medically relevant unsolicited systemic AEs which occur within the first 30 minutes after vaccination.
Time frame: Within 30 minutes after vaccination
Number of participants with solicited injection site reactions
Solicited injection site reactions (pre-listed in the participant diary and CRF)
Time frame: Up to 7 days after vaccination
Number of participants with solicited systemic reaction
Solicited systemic reactions (pre-listed in the participant diary and CRF)
Time frame: Up to 7 days after vaccination
Number of participants with unsolicited AEs
An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, ie, pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Time frame: Up to 28 days after vaccination
Number of participants with medically attended adverse events (MAAEs)
An MAAE is a new-onset or a worsening of a condition that prompts the participant or participant's parent(s)/legally acceptable representative(s) to seek unplanned medical advice at a physician's office or Emergency Department.
Time frame: Throughout the study, approximately 180 days
Number of participants with adverse events of special interest (AESIs)
An adverse event of special interest (serious or non-serious) is one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate.
Time frame: Throughout the study, approximately 180 days
Number of participants with serious adverse events (SAEs)
A SAE is defined as any adverse event that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was other medically important event.
Time frame: Throughout the study, approximately 180 days