Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)

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 healthy young children, adolescents, and adults.

Official Title
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A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging 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 Children and Adults Ages 3 to 64 Years

Conditions
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Novel 2009 Influenza H1N1

Intervention / Treatment
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* Biological: MF59-eH1N1_f
* Biological: eH1N1_f


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children, adolescents, and adults 3 to 64 years of age 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. For additional entry criteria, please refer to protocol.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 64 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2x7.5adj<br>Two doses of MF59 adjuvanted (adj) A/H1N1 | Biological: MF59-eH1N1_f<br>* MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal<br>|
| Experimental: 7.5adj_1_8<br>MF59 adjuvanted (adj) A/H1N1 on days 1 and 8 | Biological: MF59-eH1N1_f<br>* MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal<br>|
| Experimental: 7.5adj_1_22<br>MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22 | Biological: MF59-eH1N1_f<br>* MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal<br>|
| Experimental: 15_1_22<br>A/H1N1 on study days 1 and 22 | Biological: eH1N1_f<br>* Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal<br>|
| Experimental: 2x15_1_22<br>Two doses of A/H1N1 (one in each arm) on study days 1 and 22 | Biological: eH1N1_f<br>* Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age | Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS). | Day 1 to day 387 | 
| Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age | Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS). | Day 1 to day 387 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age Distribution at Baseline |  | Baseline | 
| Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years | Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS). | Day 1 to day 387 | 
| HI GMRs, in 3 to <9 Years and 9 to 17 Years | Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the the per-protocol set (PPS). | Day 1 to day 387 | 
| HI GMR, in Adults 18 to 64 Years | Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the Per-Protocol Set (PPS). | Day 1 to day 387 | 
| Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years | Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the per-protocol set (PPS). | 7 days and 21 days after each vaccination | 
| Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age | Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age). Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination | 7 days after each vaccination | 
| Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age | Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age). Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination. | 7 days after each vaccination | 
| Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age | Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age). Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination. The analyses were performed on the safety set. | 7 days after each vaccination | 

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