Evaluation of Seasonal Influenza Vaccine for 2010-2011 in Young Children

June 21, 2011 updated by: Dalhousie University

PCIRN Evaluation of Seasonal Trivalent Influenza Vaccine for 2010-2011 in Young Children in the First Year After the H1N1 Pandemic

The seasonal influenza vaccination program for 2010-2011 will be the first to follow the H1N1 pandemic of 2009. Many children 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 trivalent inactivated product (regular seasonal influenza vaccine)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 children who received one or two doses of 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 200 children (50 at each site) 12-59 month olds, 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 one or two doses of the adjuvanted H1N1 vaccine before January 31, 2010. To eligible participants do not need a previous years seasonal flu vaccine(TIV)however, this will be recorded.

The study involves 1-2 vaccination visits 28 days apart. Those children who have not received a previous dose of TIV will receive a second dose at visit # 2. 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 at each study visit (2 or 3 visits depending on previous TIV history) to measure immune responses to the seasonal vaccine.

The study will take 21-42 days to complete, depending upon whether or not the child received a previous dose of seasonal TIV vaccination. The 4 study sites are in Vancouver, Calgary, Montreal and Halifax.

Each subject's parent will be asked to keep daily notes of any changes at the injection site (pain, redness, swelling) and any general symptoms (such as irritability, drowsiness, decreased appetite, sleep disturbance,sweating and shivering, including your axilla or rectal temperature, for 7 days after each vaccination. Major health changes will be assessed for 21 days post vaccination.

Study Type

Interventional

Enrollment (Actual)

200

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
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Candian Center for Vaccinology, Dalhousie University
    • Quebec
      • Montreal, Quebec, Canada
        • McGill University Health Centre - Vaccine Study Centre

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

1 year to 4 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent provided for the subject by a parent or legal guardian.
  • Subjects whose parents the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, record safety observations, able to converse with study personnel including by telephone).
  • Age 12-59 months at Visit 1, male or female
  • Receipt of one or two doses of Arepanrix (adjuvanted H1N12009 vaccine, GlaxoSmithKline (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 Arepanrix after January 31st , 2010
  • Receipt of non-study TIV (Trivalent Influenza Vaccine)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
  • Receipt of blood or any blood-derived products within the past 3 months
  • Chronic illness at a stage that could interfere with trial participation (stable health conditions are acceptable, such as diabetes, lung disease, heart conditions etc)
  • Immune compromise as a result of a medical condition, transplantation or immunosuppressive medication, not including topical or aerosol medications
  • Participation in any other research study involving a non-approved drug or medical device

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluviral
0.25 mL Fluviral for children up to and including 35 months of age 0.50 mL Fluviral for children 36-59 months of age
Biological: Fluviral
0.25 mL Fluviral for children up to and including 35 months of age 0.50 mL Fluviral for children 36-59 months of age
Other Names:
  • Influenza Virus Vaccine
  • Trivalent, Inactivated
  • Split Virion
  • Prepared in Eggs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety of 2010-2011 seasonal trivalent influenza vaccine (TIV)
Time Frame: 7 days
Assessing reactogenicity on days 1-6 following TIV administration.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure immune response to each component of TIV.
Time Frame: 42 days
Determining if there is a relationship between pre-TIV influenza haemagglutinin titers (ie, 6 to 10 months after receipt of adjuvanted vaccine), post TIV titers, and reactogenicity following TIV receipt.
42 days

Collaborators and Investigators

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

Sponsor

Dalhousie University

Collaborators

GlaxoSmithKline
Canadian Institutes of Health Research (CIHR)
IWK Health Centre

Investigators

  • Principal Investigator: Joanne Langley, MD, Dalhousie University

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

Helpful Links

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

September 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

August 11, 2010

First Submitted That Met QC Criteria

August 11, 2010

First Posted (Estimate)

August 12, 2010

Study Record Updates

Last Update Posted (Estimate)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCIRN RT-07

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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