NCT00213967

Brief Summary

This study will determine whether decreasing pain associated with intramuscular injection by decreasing needle temperature could be an inexpensive, simple way to decrease injection fear and increase immunization rates.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

October 5, 2015

Status Verified

January 1, 2008

Enrollment Period

1.2 years

First QC Date

September 13, 2005

Last Update Submit

October 1, 2015

Conditions

Influenza

Keywords

Influenza vaccine

Outcome Measures

Primary Outcomes (1)

  • Pain level

Secondary Outcomes (1)

  • Antibody Response

Interventions

22 gauge 1 1/2 inch needles on a 3 ml syringeDEVICE

cold needles or needles kept at room temperature

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults

You may not qualify if:

  • Immunosuppressive medications or medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Influenza, Human

Interventions

Syringes

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Mary S Hayney, PharmD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

October 1, 2005

Primary Completion

December 1, 2006

Study Completion

January 1, 2007

Last Updated

October 5, 2015

Record last verified: 2008-01