Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT02069496
NCT02069496CompletedNot Applicable

Drug Use Investigation for Arepanrix® (H1N1)

GlaxoSmithKline0 sites3,405 target enrollmentStarted: February 2010Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
3,405
Primary Endpoint
The number of recipients who have adverse reactions after injection
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study 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

Study Design

Study Type
Observational
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Similar Trials

Completed
Not Applicable
Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism TreatmentAtaxia
NCT01428531GlaxoSmithKline200
Completed
Not Applicable
Special Drug Use Investigation for ARIXTRA® (Fondaparinux) InjectionThromboembolism
NCT01420809GlaxoSmithKline1,280
Completed
Not Applicable
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Eraxis® IVCandidemiaOther Forms of Candida Infections(Intra-abdominal Abscess, Peritonitis)
NCT00802854Pfizer244
Completed
Not Applicable
Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)Varicella
NCT01390857GlaxoSmithKline379
Completed
Not Applicable
Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and ChildrenRheumatoid Arthritis
NCT00484809Wyeth is now a wholly owned subsidiary of Pfizer100