Drug Use Investigation for Arepanrix® (H1N1)
NCT02069496 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3405
Last updated 2014-02-24
Summary
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\>
1. Allergic reactions
2. Anaphylaxis
Conditions
Interventions
- BIOLOGICAL
-
Arepanrix®
Injected according to the prescribing information in the locally approved label by the authorities.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-02-28
- Primary Completion
- 2010-07-31
- Completion
- 2010-10-31
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