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

NCT ID: NCT01000584

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 309 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-02-28

Brief Summary

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

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.

Conditions

Influenza; H1N1 2009 Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

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

Group Type: OTHER

Arepanrix, Vaxigrip 2009/2010

Intervention Type: BIOLOGICAL

Group A: Single dose of Arepanrix and single dose of Vaxigrip 2009/2010 given concurrently

2

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

Group Type: OTHER

Arepanrix, Vaxigrip 2009/2010

Intervention Type: BIOLOGICAL

Group B: Single dose of Vaxigrip 2009/2010 given 3 weeks after single dose of Arepanrix

Interventions

Arepanrix, Vaxigrip 2009/2010

Group A: Single dose of Arepanrix and single dose of Vaxigrip 2009/2010 given concurrently

Intervention Type: BIOLOGICAL

Arepanrix, Vaxigrip 2009/2010

Group B: Single dose of Vaxigrip 2009/2010 given 3 weeks after single dose of Arepanrix

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

David Scheifele

OTHER

Sponsor Role: lead

Responsible Party

David Scheifele

Director Vaccine Evaluation Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David Scheifele, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Allison McGeer, MD

Role: STUDY_DIRECTOR

University of Toronto, Mt Sinai Hospital

Mark Loeb, MD

Role: STUDY_DIRECTOR

McMaster University

Ian Gemmill, MD

Role: STUDY_DIRECTOR

Kingston, Frontenac, Lanark Health Unit

Marc Dionne, MD

Role: STUDY_DIRECTOR

Institut national de sante publique du Quebec

Locations

McMaster University

Hamilton, Ontario, Canada

Kingston, Frontenac, Lanark Health Unit

Kingston, Ontario, Canada

University of Toronto, Mt Sinai Hospital

Toronto, Ontario, Canada

Institut national de sante publique du Quebec

Québec, Quebec, Canada

Countries

Canada

References

Scheifele DW, Ward BJ, Dionne M, Vanderkooi OG, Loeb M, Coleman BL, Li Y; PHAC/CIHR Influenza Research Network (PCIRN). Compatibility of ASO3-adjuvanted H1N1pdm09 and seasonal trivalent influenza vaccines in adults: results of a randomized, controlled trial. Vaccine. 2012 Jul 6;30(32):4728-32. doi: 10.1016/j.vaccine.2012.05.029. Epub 2012 May 28.

Reference Type: DERIVED

PMID: 22652402 (View on PubMed)

Other Identifiers

H09-02811

Identifier Type: -

Identifier Source: org_study_id