An observational study in Influenza, sponsored by GlaxoSmithKline. Completed. Per ClinicalTrials.gov, last updated 2014-02-24.
Sponsored by GlaxoSmithKline · Observational
This post-marketing surveillance study is designed to collect safety information such as post-vaccination adverse events and adverse reactions from recipients of Arepanrix® (H1N1) Intramuscular Injection.
The following items will be investigated as priority investigation items. \<Priority investigation items>
GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Japanese subjects who receive Arepanrix® intramuscular injection for the first time
Exclusion Criteria:
Subjects who receive Arepanrix® as per routine practice
Biological: Arepanrix®
Injected according to the prescribing information in the locally approved label by the authorities.
The number of recipients who have adverse reactions after injection
Time frame: 29 days
The number of recipients who have post-vaccination adverse events after injection
Time frame: 29 days
The number of recipients who have allergic reactions after injection
Time frame: 29 days
The number of recipients who have anaphylaxis after injection
Time frame: 29 days
No study locations are listed for this record.
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline