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

• ClinicalTrials.gov Identifier: NCT01000584
• Recruitment Status: Completed
• First Posted: October 23, 2009
• Last Update Posted: April 10, 2015
• Sponsor: David Scheifele
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Information provided by (Responsible Party): David Scheifele, University of British Columbia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Influenza; H1N1 2009 Influenza	Biological: Arepanrix, Vaxigrip 2009/2010	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 309 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults, Including Randomized Comparison of Concurrent or Delayed Seasonal Influenza Vaccination
• Study Start Date: November 2009
• Actual Primary Completion Date: February 2010
• Actual Study Completion Date: February 2010

Arms and Interventions

Arm	Intervention/treatment
1; Group A: One dose of the licensed H1N1 vaccine and one dose of the seasonal influenza vaccine given concurrently	Biological: Arepanrix, Vaxigrip 2009/2010; 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	Biological: Arepanrix, Vaxigrip 2009/2010; Group B: Single dose of Vaxigrip 2009/2010 given 3 weeks after single dose of Arepanrix

Outcome Measures

Primary Outcome Measures :

1. Occurrence of adverse events (AEs) for days 0-6 after each vaccination [ Time Frame: Day 7 and Day 21 post vaccination ]
2. Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination [ Time Frame: Day 7 and Day 21 post vaccination ]

Secondary Outcome Measures :

1. Immunogenicity: Comparison of baseline and post-immunization antibody titres [ Time Frame: Day 21 post vaccination ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 59 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Canada, Ontario

McMaster University

Hamilton, Ontario, Canada

Kingston, Frontenac, Lanark Health Unit

Kingston, Ontario, Canada

University of Toronto, Mt Sinai Hospital

Toronto, Ontario, Canada

Canada, Quebec

Institut national de sante publique du Quebec

Quebec City, Quebec, Canada

Sponsors and Collaborators

David Scheifele

Canadian Institutes of Health Research (CIHR)

Investigators

• Principal Investigator: David Scheifele, MD; University of British Columbia
• Study Director: Allison McGeer, MD; University of Toronto, Mt Sinai Hospital
• Study Director: Mark Loeb, MD; McMaster University
• Study Director: Ian Gemmill, MD; Kingston, Frontenac, Lanark Health Unit
• Study Director: Marc Dionne, MD; Institut national de sante publique du Quebec

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: David Scheifele, Director Vaccine Evaluation Center, University of British Columbia
• ClinicalTrials.gov Identifier: NCT01000584
• Other Study ID Numbers: H09-02811
• First Posted: October 23, 2009
• Last Update Posted: April 10, 2015
• Last Verified: April 2015

Keywords provided by David Scheifele, University of British Columbia:

vaccine; H1N1; influenza; H1N1 influenza vaccine; influenza vaccine; seasonal Influenza

Additional relevant MeSH terms:

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases