Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

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 2009 (swine flu) vaccine in healthy young children

Official Title
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Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

Conditions
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Influenza

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 6 to 35 months 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: 6 Months
Maximum Age: 35 Months

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3.75_(50)MF59<br>3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | Biological: MF59-eH1N1_f<br>* 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.<br>|
| Experimental: 7.5_(0)MF59<br>7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | Biological: MF59-eH1N1_f<br>* 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.<br>|
| Experimental: 7.5_(50)MF59<br>7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | Biological: MF59-eH1N1_f<br>* 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.<br>|
| Experimental: 15_(0)MF59<br>15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | Biological: MF59-eH1N1_f<br>* 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody Responses After the First and Second Vaccinations | CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. | 21 days after each vaccination | 
| Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination. | Day 1 to 7 | 
| Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination. | Day 22 to 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity Measurement by Geometric Mean Titers (GMT) | Immunogenicity was measured in terms of the GMT at 21 days after each vaccination. | 21 days after each vaccination | 
| Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines. | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) | 
| Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines. | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) | 
| Antibody Response Based on Baseline Seropositivity | Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) | 
| Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10). | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) | 
| Antibody Persistence by Geometric Mean Titers (GMT) | Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination. | 6 months (Day 202) and 12 months (Day 387) after second vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flu, Swine Flu, Vaccine, Children, Adjuvant, A/H1N1 2009 Influenza