Influenza Clinical Trial
Official title:
Drug Use Investigation for Arepanrix® (H1N1)
Verified date | August 2012 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
Study type | 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>
1. Allergic reactions
2. Anaphylaxis
Status | Completed |
Enrollment | 3405 |
Est. completion date | October 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Subjects who receive Arepanrix® intramuscular injection for the first time Exclusion Criteria: |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Suminobu Ito et al. (2013) Post-marketing Surveillance of AS03-adjuvanted Influenza (H1N1) Vaccine in Japan. Pharma Medica. 31(4):135-141.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of recipients who have adverse reactions after injection | 29 days | No | |
Primary | The number of recipients who have post-vaccination adverse events after injection | 29 days | No | |
Primary | The number of recipients who have allergic reactions after injection | 29 days | No | |
Primary | The number of recipients who have anaphylaxis after injection | 29 days | No |
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