Influenza Clinical Trial
Official title:
PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine After One andTtwo Doses in Young Children
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 compare the safety and effectiveness (immune response) to one or two doses of adjuvanted H1N12009 influenza vaccine in young children. An adjuvant is an additive that can boost the immune response. The study will enroll 300 children (ages 6-35 months). Participants will receive 2 doses of adjuvanted H1N12009 vaccine 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 6 weeks.
Status | Completed |
Enrollment | 167 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 35 Months |
Eligibility |
Inclusion Criteria: - Written informed consent provided for the subject by a parent or legal guardian - Children age 6-35 months Exclusion Criteria: - Allergies to eggs, thimerosal, gentamicin sulphate or latex - Life-threatening reaction to previous Flu vaccine - Bleeding disorder - Pregnancy - Receipt of blood or blood products in past 3 months - Chronic illness that could interfere with trial participation - Compromised immune system - Previous lab-confirmed H1N12009 infection - Receipt of H1N12009 vaccine - Receipt of Seasonal Influenza vaccine since March 2009 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Children's Hospital, University of Calgary | Calgary | Alberta |
Canada | Canadian Center for Vaccinology, Dalhousie University | Halifax | Nova Scotia |
Canada | McGill University Health Center - Vaccine Study Center | Montreal | Quebec |
Canada | Unité de Recherche en Santé Publique (CHUQ) | Quebec City | Quebec |
Canada | Child and Family Research Institute | Vancouver | British Columbia |
Canada | Vaccine Evaluation Center, University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Canadian Institutes of Health Research (CIHR), PHAC/CIHR Influenza Research Network |
Canada,
Scheifele DW, Ward BJ, Dionne M, Vanderkooi O, Langley JM, Dobson S, Li Y, Law B, Halperin SA; Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) Rapid Trials Investigators. Evaluation of adjuvanted pa — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and immunogenicity of one and two doses Arepanrix | To compare the safety and immunogenicity of one and two doses of adjuvanted H1N12009 pandemic vaccine in children 6-35 months of age | Day 7 and Day 21 post vaccination measured at day 42 | Yes |
Primary | Rapid Trial | To conduct this trial soon after the vaccines become available and share observations with health officials and the public as soon as possible | Day 42 | No |
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