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

April 8, 2015 updated by: David Scheifele

PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Adults, Including Randomized Comparison of Concurrent or Delayed Seasonal Influenza Vaccination

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

309

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Biological: Arepanrix, Vaxigrip 2009/2010
Group B: Single dose of Vaxigrip 2009/2010 given 3 weeks after single dose of Arepanrix
Other: 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 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunogenicity: Comparison of baseline and post-immunization antibody titres
Time Frame: Day 21 post vaccination
Day 21 post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Scheifele

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

October 22, 2009

First Posted (Estimate)

October 23, 2009

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H09-02811

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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