InfluenzaNCT00822627
Influenza Vaccination in the Emergency Department
A study testing Influenza Vaccination and Education and referral in people with Influenza, run by University of Arizona at 1 site in United States.
Trial summary
Randomized controlled trial of influenza vaccination versus referral for vaccination in the Emergency department. Is the Emergency Department an effective venue for vaccination for influenza? Does vaccination for influenza in the Emergency Department change the rates of influenza, influenza-like-illness or medical… Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza Vaccination and Education and referral
- Type of treatment
- Vaccines, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Unvaccinated patients presenting to the Emergency Department aged 6 months or more who have at least one high risk attribute:
- Age 6-59 months or >50 years
- Pregnant
- Health care worker
- Aged 6 months-18 years on chronic aspirin therapy
- Comorbidity (cardiovascular disease, pulmonary disease, metabolic disease, renal disease, hepatic disease, seizures, neuromuscular disease, cognitive dysfunction, or any reason to have had regular medical follow up or hospitalization in the preceding year)
- Household contact or caregiver of someone with at least one high risk attribute
Who cannot join
- Prior vaccination
- History of Guillan-Barre syndrome within 6 weeks of prior influenza vaccination
- Allergy to influenza vaccination or eggs
- Age < 6 months old
- Fever with more than minor illness
- Hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Randomized controlled trial of influenza vaccination versus referral for vaccination in the Emergency department. Is the Emergency Department an effective venue for vaccination for influenza? Does vaccination for influenza in the Emergency Department change the rates of influenza, influenza-like-illness or medical provider visits when compared with patient referred for vaccination in the community?
Read the detailed description
This study is a prospective randomized, controlled trial of influenza vaccination vs referral for influenza vaccination in the Emergency Department. Subjects are either offered vaccination or education regarding vaccination and a list of community providers. At a four-month follow up, rates of influenza, influenza-like illness and number of medical provider visits are determined.
- Conditions
- Influenza
- Being tested
- Influenza Vaccination, Education and referral
- Keywords
- Influenza, vaccination, Emergency Department
- Medical subject headings
- Influenza, Human, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza VaccinationDrug
0.5 mL Sanofi-Pasteur intramuscular influenza vaccination
Education and referralBehavioural
Patients are given information regarding the inactivated influenza vaccination and a list of community providers who provide influenza vaccination
| Study group | Role | What they receive |
|---|---|---|
| Vaccination group | Experimental | Vaccination group Receives: Drug: Influenza Vaccination |
| Education/referral | Experimental | Education/referral Receives: Behavioral: Education and referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination status
Measured: 4 months
Secondary outcomes (3)
Influenza rate
Measured: 4 months
Influenza-like illness rate
Measured: 4 months
Visits to medical providers
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startNov 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Investigators
- Katherine M Hiller, MD, Principal investigator, University of Arizona Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822627
- Sponsor's protocol ID
- 1
- Status last verified
- Jan 2009
- First submitted
- 12 Jan 2009
- Last updated
- 14 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Vaccination in the Emergency Department
- ClinicalTrials.gov ID
- NCT00822627
- Acronym / sponsor ID
- 1
- Conditions
- Influenza
- Keywords
- Influenza, vaccination, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized controlled trial of influenza vaccination versus referral for vaccination in the Emergency department. Is the Emergency Department an effective venue for vaccination for influenza? Does vaccination for influenza in the Emergency Department change the rates of influenza, influenza-like-illness or medical provider visits when compared with patient referred for vaccination in the community?
Detailed description
This study is a prospective randomized, controlled trial of influenza vaccination vs referral for influenza vaccination in the Emergency Department. Subjects are either offered vaccination or education regarding vaccination and a list of community providers. At a four-month follow up, rates of influenza, influenza-like illness and number of medical provider visits are determined.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccination group | Experimental | Drug: Influenza VaccinationVaccination group |
| Education/referral | Experimental | Behavioral: Education and referralEducation/referral |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Unvaccinated patients presenting to the Emergency Department aged 6 months or more who have at least one high risk attribute:
- Age 6-59 months or >50 years
- Pregnant
- Health care worker
- Aged 6 months-18 years on chronic aspirin therapy
Key exclusion criteria (6 listed)
- Prior vaccination
- History of Guillan-Barre syndrome within 6 weeks of prior influenza vaccination
- Allergy to influenza vaccination or eggs
- Age < 6 months old
- Fever with more than minor illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza Vaccination0.5 mL Sanofi-Pasteur intramuscular influenza vaccination | Drug | Vaccination group |
| Education and referralPatients are given information regarding the inactivated influenza vaccination and a list of community providers who provide influenza vaccination | Behavioural | Education/referral |
Primary outcome
Vaccination status
Time frame: 4 months
3 secondary outcomes
Influenza rate
Time frame: 4 months
Influenza-like illness rate
Time frame: 4 months
Visits to medical providers
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine M Hiller, MD principal investigator
University of Arizona Department of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Influenza Vaccination and Education and referral in people with Influenza, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccination status (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2009.