VaccinationNCT02907580
Influenza Vaccine Attitudes, Intent, and Receipt: Pediatric
A study testing Local educational information and National educational information in people with Vaccination and Influenza, run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Vaccination, Influenza
- What is being tested?
- Local educational information and National educational information
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2016to 1 Jun 2017
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age at least 6 months
Who cannot join
- Receipt of influenza vaccination that season
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: 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.
- Conditions
- Vaccination, Influenza
- Being tested
- Local educational information, National educational information
- Keywords
- influenza, vaccination
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local educational informationBehavioural
Participants in this arm receive educational information regarding influenza vaccination based on local educational information.
National educational informationBehavioural
Participants in this arm receive educational information regarding influenza vaccination based on national educational information.
| Study group | Role | What they receive |
|---|---|---|
| Local educational data | Experimental | Local-based educational handout Receives: Behavioral: Local educational information |
| National educational data | Experimental | National-based educational handout Receives: Behavioral: National educational information |
| Usual care | No intervention | No educational information other than provided as usual care by health care providers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children who receive influenza vaccination on day of intervention
Receipt of influenza vaccination by the child on the day of the educational intervention
Measured: Day 0
Secondary outcomes (2)
Number of children who receive influenza vaccination during the influenza vaccine season
Receipt of influenza vaccination by the child by April 2017
Measured: Up to 7 months
Number of parents who anticipate influenza vaccination during the influenza vaccine season
Parents report planned receipt of influenza vaccination by themselves by April 2017
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start13 Sep 2016
- Primary completion31 May 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VaccinationStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Stockwell, Columbia University
- Investigators
- Melissa Stockwell, MD MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907580
- Sponsor's protocol ID
- AAAQ9636
- Status last verified
- Jul 2017
- First submitted
- 8 Sep 2016
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Scott VP, Opel DJ, Reifler J, Rikin S, Pethe K, Barrett A, Stockwell MS. Office-Based Educational Handout for Influenza Vaccination: A Randomized Controlled Trial. Pediatrics. 2019 Aug;144(2):e20182580. doi: 10.1542/peds.2018-2580. Epub 2019 Jul 10.
PubMed 31292219
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Vaccine Attitudes, Intent, and Receipt
- ClinicalTrials.gov ID
- NCT02907580
- Acronym / sponsor ID
- AAAQ9636
- Conditions
- Vaccination, Influenza
- Keywords
- influenza, vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 13 Sep 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 20 Sep 2016 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Local educational data | Experimental | Behavioral: Local educational informationLocal-based educational handout |
| National educational data | Experimental | Behavioral: National educational informationNational-based educational handout |
| Usual care | No intervention | –No educational information other than provided as usual care by health care providers |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Age at least 6 months
Key exclusion criteria (1 listed)
- Receipt of influenza vaccination that season
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 |
|---|---|---|
| Local educational informationParticipants in this arm receive educational information regarding influenza vaccination based on local educational information. | Behavioural | Local educational data |
| National educational informationParticipants in this arm receive educational information regarding influenza vaccination based on national educational information. | Behavioural | National educational data |
Primary outcome
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
2 secondary outcomes
Number of children who receive influenza vaccination during the influenza vaccine season
Time frame: Up to 7 months
Number of parents who anticipate influenza vaccination during the influenza vaccine season
Time frame: Up to 7 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 27 Jul 2017.
- Derived from this study: PubMed 31292219Scott VP, Opel DJ, Reifler J, Rikin S, Pethe K, Barrett A, Stockwell MS. Office-Based Educational Handout for Influenza Vaccination: A Randomized Controlled Trial. Pediatrics. 2019 Aug;144(2):e20182580. doi: 10.1542/peds.2018-2580. Epub 2019 Jul 10.
- Individual participant dataSharing planned: No
Related trials for Vaccination
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Recruiting
Assessment of Communication Interventions on Vaccination Knowledge and Acceptance
Vaccination Knowledge and Acceptance, Informed Vaccine-decision Making
Active, not recruiting
Working Towards Empowered Community-driven Approaches to Increase Vaccination and Preventive Care Engagement
COVID-19
RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
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.
Melissa Stockwell, MD MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local educational information and National educational information in people with Vaccination and Influenza, run by Columbia University 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 1 inclusion and 1 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 27 Jul 2017. 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?
Number of children who receive influenza vaccination on day of intervention (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02907580, which also lists 1 linked publication.
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 27 Jul 2017.