Influenza
Conditions
Keywords
vaccine, influenza, H1N1 influenza vaccine, influenza vaccine, Arepanrix
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 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.
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 hospitalization. The objectives of this study are two-fold: 1. To compare the safety and immunogenicity of 1 and 2 doses of adjuvanted H1N12009 influenza vaccine in children 6-35 months of age. 2. To conduct the trial soon after the vaccines become available and share the observations with health officials and the public as soon as possible.
Interventions
BIOLOGICALadjuvanted Arepanrix
Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart
Sponsors
Canadian Institutes of Health Research (CIHR)
PHAC/CIHR Influenza Research Network
University of British Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 35 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and immunogenicity of one and two doses Arepanrix | Day 7 and Day 21 post vaccination measured at day 42 | To compare the safety and immunogenicity of one and two doses of adjuvanted H1N12009 pandemic vaccine in children 6-35 months of age |
| Rapid Trial | Day 42 | To conduct this trial soon after the vaccines become available and share observations with health officials and the public as soon as possible |
Countries
Canada
Outcome results
None listed