The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza vaccine produced by the modified manufacturing process: 1. induces immune responses comparable to that produced by the current manufacturing process 2. has an acceptable safety profile compared to a licensed trivalent seasonal influenza vaccine 3. demonstrates consistency of immune response among three different lots.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,928
East Valley Family Physicians, PLC
Chandler, Arizona, United States
Anaheim Clinical Trials
Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine
Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine Two co-primary analyses relating to this primary immunogenicity outcome measure were also performed: Outcome Measure 2 - Noninferiority Outcome Measure 3 - Lot Consistency
Time frame: 21 days post vaccination
Non-inferiority of Modified Manufacturing Process Compared to the Current Process
Non-inferiority of modified manufacturing process compared to the current process. Co-primary analysis of HIA Titer for each of the three antigens (Outcome Measure 1) was performed on a subset of the Per Protocol analysis dataset for participants 18-49 Years Old treated with Vero cell-derived trivalent influenza vaccine (VCIV) from the modified manufacturing process and VCIV manufactured with the current process
Time frame: 21 days post vaccination
Lot Consistency of the Three Modified Manufacturing Process Lots
Lot consistency of the three modified manufacturing process lots Co-primary analysis of HIA Titer for each of the three antigens (Outcome Measure 1) was performed on a subset of the Per Protocol Analysis Dataset for participants of all ages treated with three Vero cell-derived trivalent influenza vaccine (VCIV) lots manufactured from the modified process.
Time frame: 21 days post vaccination
Percentage of Participants With Fever
Percentage of participants with fever
Time frame: onset within 7 days post vaccination
Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens
Percentage of participants with seroprotective antibody titer \[reciprocal HIA titer ≥40\] for each of the three antigens contained in the vaccine
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Anaheim, California, United States
Center for Clinical Trials, LLC
Paramount, California, United States
California Research Foundation
San Diego, California, United States
Benchmark Research San Francisco
San Francisco, California, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
...and 10 more locations
Time frame: 21 days post vaccination
Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine
Seroconversion is defined as a ≥ 4-fold increase in HIA titer from baseline OR a reciprocal HIA titer ≥ 40 when there is no detectable HIA titer (reciprocal HIA titer \< 10) at baseline
Time frame: 21 days post vaccination
Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline
Time frame: 21 days post vaccination
Percentage of Participants With Solicited Systemic Reactions
Time frame: within 7 days post vaccination
Percentage of Participants With Injection Site Reactions
Time frame: within 7 days post vaccination
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Time frame: within 7 days post vaccination
Percentage of Participants With Adverse Events
Time frame: within 21 days post vaccination
Frequency and Severity of Related Adverse Events
Frequency and severity of adverse events considered related to the vaccination (possibly related, probably related, unknown) according to System Organ Class (SOC) and Preferred Term (PT) SOCs are abbreviated as follows:- BLD- Blood and lymphatic system disorders EAR- Ear and labyrinth disorders EYE- Eye disorders GID- Gastrointestinal disorders GEN- General disorders and administration site conditions IMM- Immune system disorders INF- Infections and infestations MET- Metabolism and nutrition disorders MSK- Musculoskeletal and connective tissue disorders NER- Nervous system disorders RES- Respiratory, thoracic and mediastinal disorders SKN- Skin and subcutaneous tissue disorders VAS- Vascular disorders SYS-Systemic LOC-Local
Time frame: within 21 days post vaccination