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Comparison of Two Methods of Immunization for Intramuscular Injections

Comparison of Two Methods of Immunization for Intramuscular Injections

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01721083
Enrollment
511
Registered
2012-11-05
Start date
2012-10-31
Completion date
2014-07-31
Last updated
2014-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Consequences of Immunization Method

Keywords

intramuscular injection, bunch, z-track

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.

Interventions

PROCEDUREProcedure: Z-track

Subject received immunization by z-track

PROCEDUREProcedure: Bunch

Subject receives immunization by bunch method.

Sponsors

Christiana Care Health Services
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* healthy adults without latex allergy over 18 years of age

Exclusion criteria

* latex allergy * illness * 18 years or less

Design outcomes

Primary

MeasureTime frameDescription
Perceived pain72 hoursSubjects will be asked to rate perceived pain on scale of 0-10

Secondary

MeasureTime frameDescription
Medication leakage72 hoursAny medication leakage from either arm within 72 hours
Redness at injection site72 hoursRedness, as determined by naive observer at injection site immediately and up to 72 hours after study.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026