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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01000584
First received: October 21, 2009
Last updated: February 9, 2010
Last verified: February 2010
History of Changes
  Purpose

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 Intervention Phase
Influenza
H1N1 2009 Influenza
 Biological: Arepanrix, Vaxigrip 2009/2010
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Occurrence of adverse events (AEs) for days 0-6 after each vaccination [ Time Frame: Day 7 and Day 21 post vaccination ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity: Comparison of baseline and post-immunization antibody titres [ Time Frame: Day 21 post vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: November 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   20 Years to 59 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000584

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
University of British Columbia
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

No publications provided by University of British Columbia

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

Responsible Party: Dr. David Scheifele, University of British Coumbia
ClinicalTrials.gov Identifier: NCT01000584     History of Changes
Other Study ID Numbers: H09-02811
Study First Received: October 21, 2009
Last Updated: February 9, 2010
Health Authority: Canada: Health Canada

Keywords provided by 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

ClinicalTrials.gov processed this record on May 16, 2013