Comparison of Two Methods of Immunization for Intramuscular Injections

Phase 4

Completed

• Conditions: Consequences of Immunization Method

• Registration Number: NCT01721083
• Lead Sponsor: Christiana Care Health Services

Brief Summary

This study is designed to compare two different styles of intramuscular injection (Bunch versus Z-Track)during flu vaccination with the following outcome measures as basis for comparison: perceive pain, redness, medication leakage, other complications within 72 hours in healthy adult volunteer subjects.

Detailed Description

This study is designed to compare two different styles of intramuscular injection (Bunch versus Z-Track)during flu vaccination with the following outcome measures as basis for comparison: perceive pain, redness, medication leakage, other complications within 72 hours in healthy adult volunteer subjects.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-11-02
• Study First Posted: 2012-11-04
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-15
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 511

Inclusion Criteria

• healthy adults without latex allergy over 18 years of age

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Exclusion Criteria

• latex allergy
• illness
• 18 years or less

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perceived pain	72 hours	Subjects will be asked to rate perceived pain on scale of 0-10

Secondary Outcome Measures

Name	Time	Method
Medication leakage	72 hours	Any medication leakage from either arm within 72 hours
Redness at injection site	72 hours	Redness, as determined by naive observer at injection site immediately and up to 72 hours after study.

Trial Locations

Locations (1)

Christiana Care Health System; 🇺🇸 Newark, Delaware, United States