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

Primary Purpose

Influenza, H1N1 2009 Influenza

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Arepanrix, Vaxigrip 2009/2010
Arepanrix, Vaxigrip 2009/2010
Sponsored by
David Scheifele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring vaccine, H1N1, influenza, H1N1 influenza vaccine, influenza vaccine, seasonal Influenza

Eligibility Criteria

20 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • McMaster University
  • Kingston, Frontenac, Lanark Health Unit
  • University of Toronto, Mt Sinai Hospital
  • Institut national de sante publique du Quebec

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Occurrence of adverse events (AEs) for days 0-6 after each vaccination
Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination

Secondary Outcome Measures

Immunogenicity: Comparison of baseline and post-immunization antibody titres

Full Information

First Posted
October 21, 2009
Last Updated
April 8, 2015
Sponsor
David Scheifele
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01000584
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Scheifele
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
The objectives of this study are two-fold: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, H1N1 2009 Influenza
Keywords
vaccine, H1N1, influenza, H1N1 influenza vaccine, influenza vaccine, seasonal Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
309 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Group A: One dose of the licensed H1N1 vaccine and one dose of the seasonal influenza vaccine given concurrently
Arm Title
2
Arm Type
Other
Arm Description
Group B: One dose of seasonal influenza vaccine given 3 weeks after administration of one dose of the licensed H1N1 vaccine
Intervention Type
Biological
Intervention Name(s)
Arepanrix, Vaxigrip 2009/2010
Intervention Description
Group A: Single dose of Arepanrix and single dose of Vaxigrip 2009/2010 given concurrently
Intervention Type
Biological
Intervention Name(s)
Arepanrix, Vaxigrip 2009/2010
Intervention Description
Group B: Single dose of Vaxigrip 2009/2010 given 3 weeks after single dose of Arepanrix
Primary Outcome Measure Information:
Title
Occurrence of adverse events (AEs) for days 0-6 after each vaccination
Time Frame
Day 7 and Day 21 post vaccination
Title
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 Measure Information:
Title
Immunogenicity: Comparison of baseline and post-immunization antibody titres
Time Frame
Day 21 post vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Scheifele, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Allison McGeer, MD
Organizational Affiliation
University of Toronto, Mt Sinai Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mark Loeb, MD
Organizational Affiliation
McMaster University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ian Gemmill, MD
Organizational Affiliation
Kingston, Frontenac, Lanark Health Unit
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marc Dionne, MD
Organizational Affiliation
Institut national de sante publique du Quebec
Official's Role
Study Director
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Kingston, Frontenac, Lanark Health Unit
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
University of Toronto, Mt Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Institut national de sante publique du Quebec
City
Quebec City
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22652402
Citation
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.
Results Reference
derived

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

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