Drug Use Investigation for Arepanrix® (H1N1)
1 other identifier
observational
3,405
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2010
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 20, 2014
CompletedFirst Posted
Study publicly available on registry
February 24, 2014
CompletedFebruary 24, 2014
August 1, 2012
5 months
February 20, 2014
February 20, 2014
Conditions
Outcome Measures
Primary Outcomes (4)
The number of recipients who have adverse reactions after injection
29 days
The number of recipients who have post-vaccination adverse events after injection
29 days
The number of recipients who have allergic reactions after injection
29 days
The number of recipients who have anaphylaxis after injection
29 days
Study Arms (1)
Subjects who receive Arepanrix®
Subjects who receive Arepanrix® as per routine practice
Interventions
Injected according to the prescribing information in the locally approved label by the authorities.
Eligibility Criteria
Japanese subjects who receive Arepanrix® intramuscular injection for the first time
You may qualify if:
- Subjects who receive Arepanrix® intramuscular injection for the first time
You may not qualify if:
- Not applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Related Publications (1)
Suminobu Ito et al. (2013) Post-marketing Surveillance of AS03-adjuvanted Influenza (H1N1) Vaccine in Japan. Pharma Medica. 31(4):135-141.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2014
First Posted
February 24, 2014
Study Start
February 1, 2010
Primary Completion
July 1, 2010
Study Completion
October 1, 2010
Last Updated
February 24, 2014
Record last verified: 2012-08