A/H1N1 Immunogenicity and Safety in Adults

Study Overview
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Brief Summary
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The purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and older.

Official Title
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An Open Label Phase 1/2 Study to Assess Immunogenicity and Safety of Different Dose Levels of H1N1 Pandemic Influenza Vaccine in Healthy Adults Aged 18 Years and Older

Conditions
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Influenza, Pandemic Influenza

Intervention / Treatment
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* Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 to 59 years old (age stratum A) or 60 years of age or older (age stratum B) at the time of screening Subject has an understanding of the study, agrees to its provisions, and gives written informed consent prior to study entry Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and the performance of a physical examination Subject is physically and mentally capable of participating in the study and willing to adhere to study procedures to include completion of all elements of the study diary If female of childbearing potential, subject has a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agrees to employ adequate birth control measures for the duration of the study Exclusion Criteria: Subject has participated in another clinical study involving an investigational drug, biological product or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an investigational drug, biological or device during the course of this study Subject has a history of exposure to A/H1N1/California/07/2009 virus or a history of vaccination with A/H1N1/California/07/2009 antigen or a closely related influenza virus antigen Subject has inherited or acquired immune deficiency Subject currently has or has a recent history of significant neurological, cardiovascular or pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1/Dose Level A<br>Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval. | Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)<br>* Two injections at a 21-day interval (Days 1 and 22)<br>|
| Experimental: Cohort 1/Dose B<br>Subjects in Cohort 1 will be randomized 1:1 to receive two vaccinations of Dose A or Dose B of H1N1 pandemic influenza vaccine at a 21-day interval. | Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)<br>* Two injections at a 21-day interval (Days 1 and 22)<br>|
| Experimental: Cohort 2/Dose C<br>A second cohort may be enrolled with all subjects in this cohort receiving two vaccinations of Dose C of H1N1 pandemic influenza vaccine at a 21-day interval. | Biological: H1N1 pandemic influenza vaccine (whole virion, Vero Cell-derived, inactivated)<br>* Two injections at a 21-day interval (Days 1 and 22)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects achieving antibody levels to A/H1N1/California/07/2009 virus that meet the definition of seroprotection and seroconversion at 21 days after the second vaccination |  | 42 days |