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Drug Use Investigation for Arepanrix® (H1N1)

NCT ID: NCT02069496

Last Updated: 2014-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3405 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Influenza

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects who receive Arepanrix®

Subjects who receive Arepanrix® as per routine practice

Arepanrix®

Intervention Type BIOLOGICAL

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

Interventions

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Arepanrix®

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Not applicable
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

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Suminobu Ito et al. (2013) Post-marketing Surveillance of AS03-adjuvanted Influenza (H1N1) Vaccine in Japan. Pharma Medica. 31(4):135-141.

Reference Type BACKGROUND

Other Identifiers

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114128

Identifier Type: -

Identifier Source: org_study_id

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