Drug Use Investigation for Arepanrix® (H1N1)

February 20, 2014 updated by: GlaxoSmithKline

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Japanese subjects who receive Arepanrix® intramuscular injection for the first time

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Not applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects who receive Arepanrix®
Subjects who receive Arepanrix® as per routine practice
Biological: Arepanrix®
Injected according to the prescribing information in the locally approved label by the authorities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of recipients who have adverse reactions after injection
Time Frame: 29 days
29 days
The number of recipients who have post-vaccination adverse events after injection
Time Frame: 29 days
29 days
The number of recipients who have allergic reactions after injection
Time Frame: 29 days
29 days
The number of recipients who have anaphylaxis after injection
Time Frame: 29 days
29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

February 20, 2014

First Submitted That Met QC Criteria

February 20, 2014

First Posted (Estimate)

February 24, 2014

Study Record Updates

Last Update Posted (Estimate)

February 24, 2014

Last Update Submitted That Met QC Criteria

February 20, 2014

Last Verified

August 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 114128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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