Drug Use Investigation for Arepanrix® (H1N1)

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

Completed

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects who receive Arepanrix® intramuscular injection for the first time

Exclusion criteria

Not applicable

Treatment and study plan

Arepanrix®

Biological

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

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Feb 24, 2014
Registry last updated: Feb 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed