Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Chronic or acute illness that would interfere with the subject's safety and/or could interfere with the evaluation of study vaccine, including known history of anaphylaxis, serious vaccine reactions or hypersensitivity, known immunodeficiency or receiving immunosuppressive therapy.
Female of childbearing potential not using acceptable contraceptive methods, pregnant or breastfeeding.

Primary Outcome Measures

Name	Time	Method
Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.	Day 22	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf	Day 1 through day 7 (without 30 min)	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.
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.	Day 22	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%.
Number of Subjects With Unsolicited Adverse Events	Day 1 through day 22	Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine.

Locations (23): Anaheim Clincial Trials
🇺🇸
Anaheim, California, United States
Northern California Clinical Research Center
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Redding, California, United States
Southern California CRC
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San Diego, California, United States
Broward Research Group
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Hollywood, Florida, United States
Comprehensive Clinical Trials, LLC
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West Palm Beach, Florida, United States
Palm Bech Research
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West Palm Beach, Florida, United States
Meridian Clinical Research
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Omaha, Nebraska, United States
Johnson County Clin-Trials, LLC
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Lenexa, Kansas, United States
Heartland Research Associates, LLC
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Wichita, Kansas, United States
Milford Emergency Associate,Inc
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Milford, Massachusetts, United States
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Anaheim Clincial Trials
🇺🇸Anaheim, California, United States