Phase 4
N=292
Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00812110 ↗Enrolled (actual)
292
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Number of Participants Who Received Influenza Vaccine. — 250 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Influenzae vaccine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Akron Children's Hospital
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Received Influenza Vaccine. |
250 | — |
| SECONDARY Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population? |
69 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00812110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.