Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
- Conditions
- Prophylaxis: Influenza
- Interventions
- Biological: TIVc_LOT ABiological: TIVc_LOT CBiological: TIVc_LOT BBiological: TIVf
- Registration Number
- NCT02256488
- Lead Sponsor
- Novartis Vaccines
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1561
- Males or females 18 through 49 years of age.
- Subjects having provided informed consent.
- Individuals in good health
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TIVc-Lot A TIVc_LOT A Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A TIVc-Lot C TIVc_LOT C Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C TIVc-Lot B TIVc_LOT B Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B TIVf TIVf Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
- 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.
Trial Locations
- Locations (23)
Anaheim Clincial Trials
🇺🇸Anaheim, California, United States
Clinical Research Solutions, LLC
🇺🇸Franklin, Tennessee, United States
PMG Research of Hickory
🇺🇸Hickory, North Carolina, United States
Palm Bech Research
🇺🇸West Palm Beach, Florida, United States
PMG Research of Raleigh
🇺🇸Raleigh, North Carolina, United States
Comprehensive Clinical Trials, LLC
🇺🇸West Palm Beach, Florida, United States
Northern California Clinical Research Center
🇺🇸Redding, California, United States
PMG Research of Charlotte
🇺🇸Charlotte, North Carolina, United States
Milford Emergency Associate,Inc
🇺🇸Milford, Massachusetts, United States
Clinical Research Associates
🇺🇸Norfolk, Virginia, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Johnson County Clin-Trials, LLC
🇺🇸Lenexa, Kansas, United States
Clinical Research Associates, Inc
🇺🇸Nashville, Tennessee, United States
Southern California CRC
🇺🇸San Diego, California, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Foothill Family Clinic, J. Lewis Research Inc.
🇺🇸Salt Lake City, Utah, United States
Foothill Family Clinc South, J. Lewis Research Inc.
🇺🇸Salt Lake City, Utah, United States
Broward Research Group
🇺🇸Hollywood, Florida, United States
Rochester Clinical Research, Inc
🇺🇸Rochester, New York, United States
Jordan River Family Medicine, J. Lewis Research, Inc.
🇺🇸South Jordan, Utah, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Meridian Clinical Research
🇺🇸Omaha, Nebraska, United States
Columbia Research Group, Inc
🇺🇸Portland, Oregon, United States