Influenza
Conditions
Keywords
Influenza prevention
Brief 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.
Interventions
0.5 mL Deltoid Intramuscular Injection X 1
Sponsors
Akron Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received Influenza Vaccine. | 1 hour | Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population? | 16 months | Number of participants who received influenza vaccine the prior year. |
Countries
United States
Participant flow
Recruitment details
During the 2008-2009 influenza season, 474 caregivers were approached. 292 agreed to participate,and had not received influenza vaccine.
Participants by arm
| Arm | Count |
|---|---|
| Caregivers Caregivers of children at high risk, per CDC definitions, of complications of influenza. | 292 |
| Total | 292 |
Baseline characteristics
| Characteristic | Caregivers |
|---|---|
| Age Continuous | 30.5 years STANDARD_DEVIATION 10.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 171 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants |
| Race (NIH/OMB) White | 100 Participants |
| Region of Enrollment United States | 292 participants |
| Sex: Female, Male Female | 235 Participants |
| Sex: Female, Male Male | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 292 |
| serious Total, serious adverse events | 0 / 292 |
Outcome results
Primary
Number of Participants Who Received Influenza Vaccine.
Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Caregivers | Number of Participants Who Received Influenza Vaccine. | 250 participants |
Secondary
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.
Time frame: 16 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Caregivers | Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population? | 69 participants |