Influenza Clinical Trial
— PCIRNRT06Official title:
A Randomized, Blinded, Placebo-controlled, Cross-over Study of the Safety and Immunogenicity of Trivalent, Inactivated Influenza Vaccine for 2010-2011
Verified date | April 2015 |
Source | University of British Columbia |
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 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.
Status | Completed |
Enrollment | 324 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 59 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | ACHIEVE Research, Alberta Children's Hospital | Calgary | Alberta |
Canada | McGill University Health Centre - Vaccine Study Centre | Montreal | Quebec |
Canada | The Ottawa Hospital Research Institute | Ottawa | Ontario |
Canada | Unité de Recherche en Santé Publique | Quebec City | Quebec |
Canada | Vaccine Evaluation Center | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Canadian Institutes of Health Research (CIHR), GlaxoSmithKline |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the safety of 2010-2011 seasonal trivalent vaccine (TIV) | 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 | Yes |
Primary | To measure immune responses to each component of TIV | 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 | No |
Primary | To observe the persistence of anti-HAI responses to H1N12009 | 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 | No |
Secondary | Vaccine-attributable rates of the observed adverse events | The secondary safety outcomes will be the vaccine-attributable rates of the observed adverse events, both local and general, | 12 weeks | Yes |
Secondary | Immunogenicity analysis performed on the according-to-protocol (ATP) cohort | 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 | No |
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