Drug Use Investigation for Arepanrix® (H1N1)

NCT02069496 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3405

Last updated 2014-02-24

No results posted yet for this study

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

Conditions

Interventions

BIOLOGICAL

Arepanrix®

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-07-31
Completion
2010-10-31

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02069496 on ClinicalTrials.gov