InfluenzaPhase 4NCT00812110
Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home
A Phase 4 study testing Influenzae vaccine in people with Influenza, run by Akron Children's Hospital at 1 site in United States.
Trial summary
We hypothesize that when offered influenza vaccine at little or no cost, in a setting where the value of the vaccine is connected to one's high risk child, vaccination rates for parents will approach 90-95%, similar to rates obtained in the Neonatal Intensive Care Unit environment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenzae vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 336 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Sep 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents or caregiver adults who accompany at-risk children to a Pediatric Care outpatient clinic appointment. High risk children are defined as those 0 to 5 years of age, or who have any of the following diagnoses:
- Sickle cell disease
- Asthma
- Cystic fibrosis
- Chronic renal disease
- Congenital heart disease
- Cancer
- Any immunodeficiency
Who cannot join
- Caregivers of children residing in group homes
- Persons whose children do not meet the Center for Disease Control (CDC) definition of high-risk
- Persons who have had allergic reactions to influenza vaccination or any other vaccination in the past
- Persons who are allergic to eggs or egg products
- Persons who are allergic to thimerosol
- Previous diagnosis of Guillain-Barré syndrome (GBS)
- Persons who are moderately to severely ill at the time the vaccination is to be given
Trial locations and contacts
1 site in 1 country.
About this study
We hypothesize that when offered influenza vaccine at little or no cost, in a setting where the value of the vaccine is connected to one's high risk child, vaccination rates for parents will approach 90-95%, similar to rates obtained in the Neonatal Intensive Care Unit environment.
- Conditions
- Influenza
- Being tested
- Influenzae vaccine
- Keywords
- Influenza prevention
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenzae vaccineDrug
Also called Fluzone
0.5 mL Deltoid Intramuscular Injection X 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Received Influenza Vaccine.
Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination
Measured: 1 hour
Secondary outcomes (1)
Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population?
Number of participants who received influenza vaccine the prior year.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter C White, MD, Principal investigator, Akron Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812110
- Sponsor's protocol ID
- 081105
- Status last verified
- Dec 2012
- First submitted
- 18 Dec 2008
- Last updated
- 23 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home
- ClinicalTrials.gov ID
- NCT00812110
- Acronym / sponsor ID
- 081105
- Conditions
- Influenza
- Keywords
- Influenza prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 19 Dec 2008 (estimated)
- Results
- Posted 23 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that when offered influenza vaccine at little or no cost, in a setting where the value of the vaccine is connected to one's high risk child, vaccination rates for parents will approach 90-95%, similar to rates obtained in the Neonatal Intensive Care Unit environment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Parents or caregiver adults who accompany at-risk children to a Pediatric Care outpatient clinic appointment. High risk children are defined as those 0 to 5 years of age, or who have any of the following diagnoses:
Key exclusion criteria (7 listed)
- Caregivers of children residing in group homes
- Persons whose children do not meet the Center for Disease Control (CDC) definition of high-risk
- Persons who have had allergic reactions to influenza vaccination or any other vaccination in the past
- Persons who are allergic to eggs or egg products
- Persons who are allergic to thimerosol
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 |
|---|---|---|
| Influenzae vaccineAlso: Fluzone0.5 mL Deltoid Intramuscular Injection X 1 | Drug | – |
Primary outcome
Number of Participants Who Received Influenza Vaccine.
Time frame: 1 hour
Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination
1 secondary outcome
Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population?
Time frame: 16 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter C White, MD principal investigator
Akron Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Influenzae vaccine in people with Influenza, run by Akron Children's Hospital 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 8 inclusion and 7 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 23 Jan 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Received Influenza Vaccine. (time frame: 1 hour). 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 23 Jan 2013.