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

Tracking Information

• First Submitted Date: October 21, 2009
• First Posted Date: October 23, 2009
• Last Update Posted Date: April 10, 2015
• Study Start Date: November 2009
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 22, 2009)

• Occurrence of adverse events (AEs) for days 0-6 after each vaccination [ Time Frame: 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 [ Time Frame: Day 7 and Day 21 post vaccination ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 22, 2009): Immunogenicity: Comparison of baseline and post-immunization antibody titres [ Time Frame: Day 21 post vaccination ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults Receiving Seasonal Influenza Vaccine
• Official Title: PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults, Including Randomized Comparison of Concurrent or Delayed Seasonal Influenza Vaccination
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention

Condition

• Influenza
• H1N1 2009 Influenza

Intervention

• Biological: Arepanrix, Vaxigrip 2009/2010
  Group A: Single dose of Arepanrix and single dose of Vaxigrip 2009/2010 given concurrently
• Biological: Arepanrix, Vaxigrip 2009/2010
  Group B: Single dose of Vaxigrip 2009/2010 given 3 weeks after single dose of Arepanrix

Study Arms

• 1
  Group A: One dose of the licensed H1N1 vaccine and one dose of the seasonal influenza vaccine given concurrently
  Intervention: Biological: Arepanrix, Vaxigrip 2009/2010
• 2
  Group B: One dose of seasonal influenza vaccine given 3 weeks after administration of one dose of the licensed H1N1 vaccine
  Intervention: Biological: Arepanrix, Vaxigrip 2009/2010

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 8, 2015): 309
• Original Estimated Enrollment (submitted: October 22, 2009): 300
• Actual Study Completion Date: February 2010
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 59 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01000584
• Other Study ID Numbers: H09-02811
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: David Scheifele, University of British Columbia
• Study Sponsor: David Scheifele
• Collaborators: 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

• PRS Account: University of British Columbia
• Verification Date: April 2015