H1N1/2009 Influenza Clinical Trial
Official title:
PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Aboriginal Children and Adults
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 purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in aboriginal children and adults. The study will enroll 200 healthy adults (ages 20-59 years) and 75 healthy children (ages 6-35 months). Adults will receive one dose of a licensed H1N1 vaccine and children will receive two doses of a licensed H1N1 vaccine approximately 3 weeks apart. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 3 weeks (adults) or 6 weeks (children).
Status | Completed |
Enrollment | 156 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 59 Years |
Eligibility |
Inclusion Criteria: - Good general health - Written informed consent provided by or for the subject - Aboriginal ethnicity (First Nations, Metis or Inuit) - Adults 20-59 years of age - Children 6-35 months of age Exclusion Criteria: - Allergies to eggs, thimerosal or gentamicin sulphate - Life-threatening reaction to previous Flu vaccine - Bleeding disorder - Pregnancy - Receipt of blood or blood products in past 3 months - Compromised immune system - Chronic illness - Previous lab-confirmed H1N1/2009 infection |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | Calgary Health Services and Alberta Children's Hospital | Calgary | Alberta |
Canada | Capital Health District, Alberta Health Services | Edmonton | Alberta |
Canada | Child and Family Research Center | Vancouver | British Columbia |
Canada | Vaccine Evaluation Center, University of British Columbia | Vancouver | British Columbia |
Canada | University of Manitoba Health Sciences Centre | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
David Scheifele | Canadian Institutes of Health Research (CIHR), PHAC/CIHR Influenza Research Network |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of adverse events (AEs) for days 0-6 after each vaccination | Day 7 and Day 21 post vaccination | Yes | |
Primary | Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination | Day 7 and Day 21 post vaccination | Yes | |
Secondary | Comparison of baseline and post-immunization antibody titres | Day 21 (adults) and Day 42 (children) | No |