Drug Use Investigation for Arepanrix® (H1N1)

N/ACompletedNCT02069496

GlaxoSmithKline3,405 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

3,405

Conditions

Influenza

Interventions

Arepanrix®BIOLOGICAL

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

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who receive Arepanrix® intramuscular injection for the first time Exclusion Criteria: * Not applicable

Outcomes

Primary Outcomes

The number of recipients who have adverse reactions after injection

Time frame: 29 days

The number of recipients who have post-vaccination adverse events after injection

Time frame: 29 days

The number of recipients who have allergic reactions after injection

Time frame: 29 days

The number of recipients who have anaphylaxis after injection

Time frame: 29 days

Data from ClinicalTrials.gov

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