Safety and Protectiveness of the Seasonal Influenza Vaccine for 2010-2011 (PCIRNRT06)

April 14, 2015 updated by: University of British Columbia

A Randomized, Blinded, Placebo-controlled, Cross-over Study of the Safety and Immunogenicity of Trivalent, Inactivated Influenza Vaccine for 2010-2011

The seasonal influenza vaccination program for 2010-2011 will be the first to follow the H1N1 pandemic of 2009. Many Canadians either had the H1N1 infection or the adjuvanted H1N1 vaccine. Both H1N1 infection and adjuvanted vaccine produced strong immune responses which could last for some time.

The seasonal influenza vaccine for this fall will be a "normal" product once again, without adjuvant. It will contain 3 strains of killed, split-apart viruses that might circulate this winter, including the H1N1 pandemic strain. It is theoretically possible that giving the H1N1-containing seasonal vaccine to people who still have some immunity to H1N1 virus could result in more frequent side-effects. However, there is no good evidence that pre-existing immunity to a strain in the vaccine does increase side-effects. In short, there could be nothing out of the ordinary this fall but it would be prudent to check this before public flu vaccination programs begin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will assess the safety of seasonal influenza vaccination in people who had the adjuvanted H1N1 vaccine last year. It will also measure residual immunity to the H1N1 virus and immune responses to the seasonal vaccine. It will be carried out before the new vaccine is released for general use so that we have an accurate picture of vaccine safety and responses for other Canadians.

A total of 320 adults (64 at each site) 20 to 59 years old, are being asked to participate in this study. A research nurse will conduct a telephone screening with potential participants to determine if they are eligible for the study. Volunteers must have had adjuvanted H1N1 vaccine before January 31, 2010.

The study involves 2 vaccination visits 10 days part. At one visit seasonal vaccine will be given and at the other a placebo vaccine will be given. Which vaccine is given first will be determined by random chance, the details of which will not be released until study end. After each vaccination, there will be contacts 1 and 7 days later for a description of any symptoms experienced. A blood sample will be requested at the first and last visits (visit 3) to measure immune responses to the seasonal vaccine.

The study will take 21-38 days to complete, depending upon the vaccination sequence and availability. Total time required to take part is about 2.5 hours. The 3 study visits will occur at a clinic in Vancouver, Calgary, Ottawa, Montreal or Quebec City.

Each subject will be asked to keep daily notes of any changes at the injection site (pain, redness, swelling) and any general symptoms (such as headache, tiredness, body aches), including your oral temperature, for 7 days after each vaccination. Major health changes will be assessed for 21 days post 'vaccination'

A special Safety Board will review the results of the first vaccinations and advise whether it is reasonable to continue the study or not.

Study Type

Interventional

Enrollment (Actual)

324

Phase

  • Phase 2

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
    • Alberta
      • Calgary, Alberta, Canada
        • ACHIEVE Research, Alberta Children's Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vaccine Evaluation Center
    • Ontario
      • Ottawa, Ontario, Canada
        • The Ottawa Hospital Research Institute
    • Quebec
      • Montreal, Quebec, Canada
        • McGill University Health Centre - Vaccine Study Centre
      • Quebec City, Quebec, Canada
        • Unité de Recherche en Santé Publique

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • Can and will comply with the requirements of the protocol
  • Age 20-59 years at Visit 1
  • Receipt of one dose of Arepanrix (adjuvanted H1N12009 vaccine, GSK) in 2009 documented by written record or attested by a confident personal recollection (window for vaccination will be 1 October 2009 to January 31, 2010).

Exclusion Criteria:

  • Systemic hypersensitivity to hens' eggs or to any other Fluviral S/F vaccine component such as thimerosal
  • History of a life-threatening reaction to any influenza vaccine
  • Receipt of non-study TIV for the 2010-2011 season
  • Receipt of any live vaccine within 4 weeks or inactivated vaccine within one week of study entry or planned administration of any non-study vaccines during the study period
  • Thrombocytopenia or any bleeding disorder that contraindicates IM injection or blood collection
  • Pregnancy, at any stage of gestation
  • Receipt of blood or any blood-derived products within 3 months prior to Visit 1
  • Chronic illness at a stage that could interfere with trial participation (stable health conditions are acceptable, such as diabetes, lung disease, heart conditions etc)
  • History of Guillain-Barre syndrome
  • Immune compromise as a result of illness or immunosuppressive medication
  • Participation in any other research study involving a non-approved drug or medical device
  • Any other condition that may interfere with ability to comply with trial procedures, including abuse of alcohol, drug addiction or imposed confinement
  • Current febrile illness or oral temperature of ≥ 38.0 °C

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group 1
FLuviral 2010/11Tri-valent Seasonal Influenza Vaccine (TIV)1st; saline placebo 10 days later
Biological: Fluviral 2010/11 Tri-valent Seasonal Influenza vaccine
Vaccination of .05mL of Fluviral vaccine will be injected once at either visit 1 or 2 depending upon randomization in the deltoid muscle of the non-dominant arm
Placebo Comparator: Group 2
Saline placebo 1st; Fluviral 2010/11 Tri-valent Seasonal Influenza Vaccine (TIV)10 days later
Biological: Fluviral 2010/11 Tri-valent Seasonal Influenza vaccine
Vaccination of .05mL of Fluviral vaccine will be injected once at either visit 1 or 2 depending upon randomization in the deltoid muscle of the non-dominant arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety of 2010-2011 seasonal trivalent vaccine (TIV)
Time Frame: 12 weeks
To evaluate the safety of 2010-2011 seasonal trivalent vaccine (TIV) in a convenience sample of adults being re-vaccinated with H1N12009 antigen, as soon as vaccine becomes available so as to inform subsequent use of the vaccine in public programs.
12 weeks
To measure immune responses to each component of TIV
Time Frame: 12 weeks
To measure immune responses to each component of TIV prior to and following seasonal vaccination to assess the immunogenicity of the new TIV vaccine.
12 weeks
To observe the persistence of anti-HAI responses to H1N12009
Time Frame: 12 weeks
To observe the persistence of anti-HAI responses to H1N12009 in a subset of subjects previously studied after vaccination with adjuvanted pandemic vaccine in late 2009 and to compare their peak responses to H1N12009 after the pandemic and TIV vaccinations.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine-attributable rates of the observed adverse events
Time Frame: 12 weeks
The secondary safety outcomes will be the vaccine-attributable rates of the observed adverse events, both local and general,
12 weeks
Immunogenicity analysis performed on the according-to-protocol (ATP) cohort
Time Frame: 12 weeks
The secondary immunogenicity outcome will be the immunogenicity analysis performed on the according-to-protocol (ATP) cohort, comprising subjects with complete data for the principal immunogenicity endpoints and no major protocol deviations. The key immunogenicity outcome will be whether the HAI antibody responses to each vaccine strain meet the EMEA/CHMP criteria (3) for seasonal TIV vaccine responses in adults <60 years of age.
12 weeks

Collaborators and Investigators

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

Sponsor

University of British Columbia

Collaborators

GlaxoSmithKline
Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: David Scheifele, Dr., University of British Columbia
  • Study Director: Simon Dobson, Dr., University of British Columbia
  • Study Director: Laura Sauve, Dr., University of British Columbia
  • Study Director: Tobias Kollmann, Dr., University of British Columbia
  • Study Director: Keswadee Lapphra, Dr., University of British Columbia
  • Study Director: Brian Ward, Dr., McGill University Health Centre - Vaccine Study Centre
  • Study Director: Marc Dionne, Dr., Unité de Recherche en Santé Publique (CHUQ)
  • Study Director: Vladimir Gilca, Dr., Unité de Recherche en Santé Publique (CHUQ)
  • Study Director: Gaston DeSerres, Dr., Unité de Recherche en Santé Publique (CHUQ)
  • Study Director: Curtis Cooper, Dr., The Ottawa Hospital Research Institute, University of Ottawa
  • Study Director: Otto Vanderkooi, Dr., ACHIEVE Research, Alberta Children's Hospital, University of Calgary and Alberta Health Services
  • Study Director: James Kellner, Dr., ACHIEVE Research, Alberta Children's Hospital, University of Calgary and Alberta Health Services
  • Study Director: Judy MacDonald, Dr., ACHIEVE Research, Alberta Children's Hospital, University of Calgary and Alberta Health Services

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

August 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (Estimate)

June 9, 2010

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H10-01356

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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