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OpenTrials
Completed

NCT Number: NCT01721083

Comparison of Two Methods of Immunization for Intramuscular Injections

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.

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Key information

Conditions

Consequences of Immunization Method

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Christiana Care Health System

Newark, Delaware, 19716, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy adults without latex allergy over 18 years of age

Exclusion criteria

  • latex allergy
  • illness
  • 18 years or less

Treatment and study plan

Procedure: Z-track

Procedure

Subject received immunization by z-track

Procedure: Bunch

Procedure

Subject receives immunization by bunch method.

Primary outcomes

  1. Perceived pain

    Time frame: 72 hours

    Subjects will be asked to rate perceived pain on scale of 0-10

Secondary outcomes

  1. Medication leakage

    Time frame: 72 hours

    Any medication leakage from either arm within 72 hours

  2. Redness at injection site

    Time frame: 72 hours

    Redness, as determined by naive observer at injection site immediately and up to 72 hours after study.

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 5, 2012
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.