The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf). The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws. Female subjects of childbearing potential were tested for pregnancy before the administration of the vaccine and included only if using and agreeing to continue to use contraception during the course of the study. The total study participation time per subject is about 3 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
1,561
Single IM (Intramuscular) administration dose of 0.5 mL of TIVc
Single IM administration dose of 0.5 mL of TIVc
Single IM administration dose of 0.5 mL of TIVc
Single IM administration dose of 0.5 mL of TIVf
Anaheim Clincial Trials
Anaheim, California, United States
Northern California Clinical Research Center
Redding, California, United States
Southern California CRC
San Diego, California, United States
Broward Research Group
Hollywood, Florida, United States
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, United States
Palm Bech Research
West Palm Beach, Florida, United States
Meridian Clinical Research
Savannah, Georgia, United States
Johnson County Clin-Trials, LLC
Lenexa, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Milford Emergency Associate,Inc
Milford, Massachusetts, United States
...and 14 more locations
Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.
Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.
Time frame: Day 22
Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.
Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22). Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine. HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen. According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%.
Time frame: Day 22
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines.
Time frame: Day 1 through day 7 (without 30 min)
Number of Subjects With Unsolicited Adverse Events
Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine.
Time frame: Day 1 through day 22
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