Title
Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults Receiving Seasonal Influenza Vaccine
PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults, Including Randomized Comparison of Concurrent or Delayed Seasonal Influenza Vaccination
Phase
Phase 4Lead Sponsor
University of British ColumbiaStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Influenza H1N1 2009 InfluenzaIntervention/Treatment
arepanrix ...Study Participants
309The 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.
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.
Group A: Single dose of Arepanrix and single dose of Vaxigrip 2009/2010 given concurrently
Group B: Single dose of Vaxigrip 2009/2010 given 3 weeks after single dose of Arepanrix
Group A: One dose of the licensed H1N1 vaccine and one dose of the seasonal influenza vaccine given concurrently
Group B: One dose of seasonal influenza vaccine given 3 weeks after administration of one dose of the licensed H1N1 vaccine
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
