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

This study has been completed.
Sponsor:
Collaborators:
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
GlaxoSmithKline
Information provided by:
Dalhousie University
ClinicalTrials.gov Identifier:
NCT01180621
First received: August 11, 2010
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Seasonal Influenza
Biological: Fluviral
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: PCIRN Evaluation of Seasonal Trivalent Influenza Vaccine for 2010-2011 in Young Children in the First Year After the H1N1 Pandemic

Resource links provided by NLM:


Further study details as provided by Dalhousie University:

Primary Outcome Measures:
  • To evaluate the safety of 2010-2011 seasonal trivalent influenza vaccine (TIV) [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Assessing reactogenicity on days 1-6 following TIV administration.


Secondary Outcome Measures:
  • To measure immune response to each component of TIV. [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 200
Study Start Date: September 2010
Study Completion Date: April 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180621

Locations
Canada, Alberta
ACHIEVE Research, Alberta Children's Hospital
Calgary, Alberta, Canada
Canada, British Columbia
Vaccine Evaluation Center
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Candian Center for Vaccinology, Dalhousie University
Halifax, Nova Scotia, Canada
Canada, Quebec
McGill University Health Centre - Vaccine Study Centre
Montreal, Quebec, Canada
Sponsors and Collaborators
Dalhousie University
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
GlaxoSmithKline
Investigators
Principal Investigator: Joanne Langley, MD Dalhousie University
  More Information

No publications provided by Dalhousie University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Joanne Langley, Canadian Center for Vaccinology
ClinicalTrials.gov Identifier: NCT01180621     History of Changes
Other Study ID Numbers: PCIRN RT-07
Study First Received: August 11, 2010
Last Updated: June 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by Dalhousie University:
vaccine
Seasonal Influenza Vaccine
Influenza Vaccine
Vaccine Safety
Vaccine Immunogenicity
Fluviral 2010-2011

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 July 26, 2014