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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects

Conditions
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Prophylaxis: Influenza

Intervention / Treatment
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* Biological: TIVc_LOT A
* Biological: TIVc_LOT B
* Biological: TIVc_LOT C
* Biological: TIVf


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females 18 through 49 years of age. Subjects having provided informed consent. Individuals in good health 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIVc-Lot A<br>Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A | Biological: TIVc_LOT A<br>* Single IM (Intramuscular) administration dose of 0.5 mL of TIVc<br>|
| Experimental: TIVc-Lot B<br>Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B | Biological: TIVc_LOT B<br>* Single IM administration dose of 0.5 mL of TIVc<br>|
| Experimental: TIVc-Lot C<br>Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C | Biological: TIVc_LOT C<br>* Single IM administration dose of 0.5 mL of TIVc<br>|
| Active Comparator: TIVf<br>Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf | Biological: TIVf<br>* Single IM administration dose of 0.5 mL of TIVf<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%. | 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. | 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. | Day 1 through day 22 |