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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01000584
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : April 10, 2015
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
David Scheifele, University of British Columbia

Tracking Information
First Submitted Date  ICMJE October 21, 2009
First Posted Date  ICMJE October 23, 2009
Last Update Posted Date April 10, 2015
Study Start Date  ICMJE November 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
Immunogenicity: Comparison of baseline and post-immunization antibody titres [ Time Frame: Day 21 post vaccination ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults Receiving Seasonal Influenza Vaccine
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Influenza
  • H1N1 2009 Influenza
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2015)
309
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2009)
300
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01000584
Other Study ID Numbers  ICMJE H09-02811
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Scheifele, University of British Columbia
Study Sponsor  ICMJE David Scheifele
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP