Status:
COMPLETED
Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
PHAC/CIHR Influenza Research Network
Conditions:
Influenza
Eligibility:
All Genders
6-35 years
Phase:
PHASE4
Brief Summary
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 c...
Detailed Description
The goal of this study is to determine if one or two doses of the H1N12009 influenza vaccine are needed in young children, a population group at high risk of influenza infection and subsequent hospita...
Eligibility Criteria
Inclusion
- Written informed consent provided for the subject by a parent or legal guardian
- Children age 6-35 months
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT01000831
Start Date
November 1 2009
End Date
February 1 2010
Last Update
April 15 2015
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Alberta Children's Hospital, University of Calgary
Calgary, Alberta, Canada
2
Child and Family Research Institute
Vancouver, British Columbia, Canada
3
Vaccine Evaluation Center, University of British Columbia
Vancouver, British Columbia, Canada
4
Canadian Center for Vaccinology, Dalhousie University
Halifax, Nova Scotia, Canada