Drug Use Investigation for Arepanrix® (H1N1)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02069496

Enrollment

3405

Registered

2014-02-24

Start date

2010-02-28

Completion date

2010-10-31

Last updated

2014-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

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

Interventions

BIOLOGICALArepanrix®

Injected according to the prescribing information in the locally approved label by the authorities.

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

* Subjects who receive Arepanrix® intramuscular injection for the first time

Exclusion criteria

* Not applicable

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026