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

David Scheifele

Status and phase: Completed; Phase 4

Conditions: Influenza; H1N1 2009 Influenza

Treatments: Biological: Arepanrix, Vaxigrip 2009/2010

Study type: Interventional

Funder types: Other

Identifiers

NCT01000584

H09-02811

Details and patient eligibility

About

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.

Full description

The objectives of this study are two-fold:

1. 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.
2. 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.

Enrollment: 309 patients

Sex: All

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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309 participants in 2 patient groups

1

Other group

Description:

Group A: One dose of the licensed H1N1 vaccine and one dose of the seasonal influenza vaccine given concurrently

Treatment:

Biological: Arepanrix, Vaxigrip 2009/2010

Biological: Arepanrix, Vaxigrip 2009/2010

2

Other group

Description:

Group B: One dose of seasonal influenza vaccine given 3 weeks after administration of one dose of the licensed H1N1 vaccine

Treatment:

Biological: Arepanrix, Vaxigrip 2009/2010

Biological: Arepanrix, Vaxigrip 2009/2010