Seasonal Influenza Clinical Trial
Official title:
PCIRN Evaluation of Seasonal Trivalent Influenza Vaccine for 2010-2011 in Young Children in the First Year After the H1N1 Pandemic
Verified date | June 2011 |
Source | Dalhousie University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | April 2011 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 12 Months to 59 Months |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | ACHIEVE Research, Alberta Children's Hospital | Calgary | Alberta |
Canada | Candian Center for Vaccinology, Dalhousie University | Halifax | Nova Scotia |
Canada | McGill University Health Centre - Vaccine Study Centre | Montreal | Quebec |
Canada | Vaccine Evaluation Center | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Dalhousie University | Canadian Institutes of Health Research (CIHR), GlaxoSmithKline, IWK Health Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the safety of 2010-2011 seasonal trivalent influenza vaccine (TIV) | Assessing reactogenicity on days 1-6 following TIV administration. | 7 days | Yes |
Secondary | To measure immune response to each component of TIV. | 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 | Yes |
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