Drug Use Investigation for Arepanrix® (H1N1)

Influenza Clinical Trial

Official title:

Drug Use Investigation for Arepanrix® (H1N1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069496
• Other study ID #: 114128
• Status: Completed
• Phase: N/A
• First received: February 20, 2014
• Last updated: February 20, 2014
• Start date: February 2010
• Est. completion date: October 2010

Study information

• Verified date: August 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• 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:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza

Intervention

Biological:
• Arepanrix®
Injected according to the prescribing information in the locally approved label by the authorities.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & Publications (1)

Suminobu Ito et al. (2013) Post-marketing Surveillance of AS03-adjuvanted Influenza (H1N1) Vaccine in Japan. Pharma Medica. 31(4):135-141.

Outcome

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