Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults Receiving Seasonal Influenza Vaccine

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in adults when given at the same time or prior to the seasonal influenza vaccine. The study will enroll 300 adults (ages 20-59 years). Participants will be randomized into 2 groups. One group will receive one dose of a licensed H1N1 vaccine and one dose of the seasonal influenza vaccine at the same time; the second group will receive the seasonal influenza vaccine 3 weeks after receiving the licensed H1N12009 influenza vaccine. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 3-6 weeks depending upon the group assignment.

Detailed Description
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The objectives of this study are two-fold: To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of adults, soon after the pandemic vaccine becomes available so as to inform the subsequent use of vaccine in public programs. To evaluate the compatibility of co-administered H1N12009 pandemic vaccine and seasonal TIV vaccine in the same group of subjects, as the option of co-administration would be useful for public programs.

Official Title
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PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults, Including Randomized Comparison of Concurrent or Delayed Seasonal Influenza Vaccination

Conditions
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Influenza, H1N1 2009 Influenza

Intervention / Treatment
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* Biological: Arepanrix, Vaxigrip 2009/2010
* Biological: Arepanrix, Vaxigrip 2009/2010


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Adults 20-59 years of age Exclusion Criteria: Allergies to eggs, thimerosal, gentamicin sulphate, neomycin Life-threatening reaction to previous Flu vaccine Bleeding disorder Pregnancy Receipt of blood or blood products in past 3 months Chronic illness Compromised immune system Previous lab-confirmed H1N12009 infection Receipt of H1N12009 vaccine Receipt of Seasonal Influenza vaccine since March 2009

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 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 |
| --- | --- |
| Other: 1<br>Group A: One dose of the licensed H1N1 vaccine and one dose of the seasonal influenza vaccine given concurrently | Biological: Arepanrix, Vaxigrip 2009/2010<br>* Group A: Single dose of Arepanrix and single dose of Vaxigrip 2009/2010 given concurrently<br>|
| Other: 2<br>Group B: One dose of seasonal influenza vaccine given 3 weeks after administration of one dose of the licensed H1N1 vaccine | Biological: Arepanrix, Vaxigrip 2009/2010<br>* Group B: Single dose of Vaxigrip 2009/2010 given 3 weeks after single dose of Arepanrix<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events (AEs) for days 0-6 after each vaccination |  | Day 7 and Day 21 post vaccination | 
| Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination |  | Day 7 and Day 21 post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity: Comparison of baseline and post-immunization antibody titres |  | Day 21 post vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, H1N1, influenza, H1N1 influenza vaccine, influenza vaccine, seasonal Influenza