Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults

Study Overview
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Brief Summary
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This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.

Official Title
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A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age

Conditions
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Influenza

Intervention / Treatment
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* Biological: MF59-eH1N1_f


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months. Exclusion Criteria: History of serious disease. History of serious reaction following administration of vaccine or hypersensitivity to vaccine components. Known or suspected impairment/alteration of immune function. Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination. Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study. For additional entry criteria, please refer to protocol.

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3.75_(50)MF59<br>50% of MF59 with 3.75 µg A/H1N1 antigen | Biological: MF59-eH1N1_f<br>* 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant<br>|
| Experimental: 7.5 w/o MF59<br>0% of MF59 with 7.5 µg A/H1N1 antigen | Biological: MF59-eH1N1_f<br>* 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant<br>|
| Experimental: 7.5_(50)MF59<br>50% of MF59 with 7.5 µg A/H1N1 antigen | Biological: MF59-eH1N1_f<br>* 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant<br>|
| Experimental: 7.5_(100)MF59<br>100% of MF59 with 7.5 µg A/H1N1 antigen | Biological: MF59-eH1N1_f<br>* 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant<br>|
| Experimental: 15 w/o MF59<br>0% of MF59 with 15 µg A/H1N1 antigen | Biological: MF59-eH1N1_f<br>* 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant<br>|
| Experimental: 15_(50)MF59<br>50% of MF59 with 15 µg A/H1N1 antigen | Biological: MF59-eH1N1_f<br>* 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant<br>|
| Experimental: 15_(100)MF59<br>100% of MF59 with 15 µg A/H1N1 antigen | Biological: MF59-eH1N1_f<br>* 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant<br>|
| Experimental: 30 w/o MF59<br>0% of MF59 with 30 µg A/H1N1 antigen | Biological: MF59-eH1N1_f<br>* 8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age | Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40. | 21 days after each vaccination | 
| Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age | Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40. | 21 days after each vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age | Geometric mean hemagglutinin inhibition (HI) titer = GMT | 21 days after each vaccination | 
| Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age | Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40. | 21 days after each vaccination | 
| Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age | Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40. | 21 days after each vaccination | 
| Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age | Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers. | 21 days after vaccination | 
| Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age | Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity. | 7 days after vaccination | 
| Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age | Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity. | 7 days after vaccination | 
| Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age | Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity. | 7 days after vaccination | 
| Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age | Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity. | 7 days after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Swine Flu, Flu, Vaccine, Adults, Elderly, Non-Elderly, Adjuvant