A Phase 4 interventional study of adjuvanted Arepanrix in Influenza, sponsored by University of British Columbia. Completed at 6 sites in Canada. Open to participants aged 6 Months to 35 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-15.
Sponsored by University of British Columbia · Phase 4, Interventional, and Prevention
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.
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:
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 167 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Two doses of adjuvanted H1N1 Arepanrix vaccine given 3 weeks apart
Biological: adjuvanted Arepanrix
Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart
Also known as: Influenza vaccine
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
Time frame: Day 7 and Day 21 post vaccination measured at day 42
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
Time frame: Day 42
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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University of British Columbia