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Clinical Trials/NCT02069496
NCT02069496
Completed
Not Applicable

Drug Use Investigation for Arepanrix® (H1N1)

GlaxoSmithKline0 sites3,405 target enrollmentFebruary 2010
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ConditionsInfluenza

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Influenza
Sponsor
GlaxoSmithKline
Enrollment
3405
Primary Endpoint
The number of recipients who have adverse reactions after injection
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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
Registry
clinicaltrials.gov
Start Date
February 2010
End Date
October 2010
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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