- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02907580
Influenza Vaccine Attitudes, Intent, and Receipt: Pediatric
July 26, 2017 updated by: Melissa Stockwell, Columbia University
Influenza Vaccine Attitudes, Intent, and Receipt
Influenza vaccine is recommended as routine care for all individuals who are at least 6 months of age and older.
Recently, questions about vaccine safety and concerns for side effects have increased, contributing to both influenza vaccine hesitancy and refusal.
In an effort to educate parents and patients, public health entities and physicians give informational handouts in various forms.
However, recent publications have found that pro-vaccine messages can have paradoxical effects on vaccine intentions, therefore further studies on vaccine related public health communication is needed.
Few, if any, studies have analyzed the relationship between influenza vaccine attitudes and intention with actual vaccine receipt in the pediatric population.
These results will help to understand the relationship between parent's vaccine perception and the intent to vaccinate versus the child's receipt of the influenza vaccine, as well as to optimize educational information given to families regarding the influenza vaccine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age at least 6 months
Exclusion Criteria:
- Receipt of influenza vaccination that season
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care
No educational information other than provided as usual care by health care providers
|
|
Experimental: Local educational data
Local-based educational handout
|
Participants in this arm receive educational information regarding influenza vaccination based on local educational information.
|
Experimental: National educational data
National-based educational handout
|
Participants in this arm receive educational information regarding influenza vaccination based on national educational information.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of children who receive influenza vaccination on day of intervention
Time Frame: Day 0
|
Receipt of influenza vaccination by the child on the day of the educational intervention
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of children who receive influenza vaccination during the influenza vaccine season
Time Frame: Up to 7 months
|
Receipt of influenza vaccination by the child by April 2017
|
Up to 7 months
|
Number of parents who anticipate influenza vaccination during the influenza vaccine season
Time Frame: Up to 7 months
|
Parents report planned receipt of influenza vaccination by themselves by April 2017
|
Up to 7 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 13, 2016
Primary Completion (Actual)
May 31, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
September 8, 2016
First Submitted That Met QC Criteria
September 15, 2016
First Posted (Estimate)
September 20, 2016
Study Record Updates
Last Update Posted (Actual)
July 27, 2017
Last Update Submitted That Met QC Criteria
July 26, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAQ9636
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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