Childhood Influenza VaccinationSKIPP RCTNCT02227186
Efficacy Study of School-located Influenza Vaccination Clinics to Increase Influenza Vaccination Rates in Monroe County, New York
A study testing School-located Influenza Vaccination Clinic in people with Childhood Influenza Vaccination and School-located Influenza Vaccination, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Children in schools in which influenza vaccination clinics are held during school hours will have higher rates of influenza vaccination than children in control schools (no school-located clinics offered) Read more about this study
- Who is it for?
- Ages 4 to 19 years
- Conditions the study is for
- Childhood Influenza Vaccination, School-located Influenza Vaccination
- What is being tested?
- School-located Influenza Vaccination Clinic
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,461 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2014to 31 Jul 2015
- 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 4 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Enrolled in participating, randomized school
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester School of Medicine and Dentistry
Rochester, New York, 14642
About this study
Official title: Study of Effectiveness of a School-located Influenza Vaccination Program in Raising Influenza Vaccination Rates
Children in schools in which influenza vaccination clinics are held during school hours will have higher rates of influenza vaccination than children in control schools (no school-located clinics offered)
- Being tested
- School-located Influenza Vaccination Clinic
- Keywords
- Influenza vaccination rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-located Influenza Vaccination ClinicOther
Children in the intervention arm are enrolled in schools in Monroe County, NY that are offering school-located influenza vaccination clinics during school hours
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | No school-located influenza vaccination clinic |
| School-located influenza vaccination clinics | Experimental | School-located influenza vaccination clinics Receives: Other: School-located Influenza Vaccination Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza vaccination status
Vaccination status for the 2014/2015 influenza season will be assessed. The vaccination date will be recorded, as well as the provider name, to determine whether vaccine was received at the school-located influenza clinic
Measured: Within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study start1 Aug 2014
- Primary completion31 Jul 2015
- Study completion31 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Childhood Influenza VaccinationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20,461 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter G Szilagyi, MD MPH, University of California, Los Angeles
- Investigators
- Peter Szilagyi, MPH, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227186
- Sponsor's protocol ID
- 5R18HS021163
- Other IDs
- 5R18HS021163
- Acronym
- SKIPP RCT
- Status last verified
- Apr 2017
- First submitted
- 25 Aug 2014
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Yoo BK, Schaffer SJ, Humiston SG, Rand CM, Goldstein NPN, Albertin CS, Concannon C, Szilagyi PG. Cost effectiveness of school-located influenza vaccination programs for elementary and secondary school children. BMC Health Serv Res. 2019 Jun 24;19(1):407. doi: 10.1186/s12913-019-4228-5.
PubMed 31234842Schaffer SJ, Rand CM, Humiston SG, Concannon C, Hightower AD, Albertin C, Szilagyi PG. Practical considerations in developing a successful school-located influenza vaccination (SLIV) program. Vaccine. 2019 Apr 10;37(16):2171-2173. doi: 10.1016/j.vaccine.2019.01.088. Epub 2019 Mar 13. No abstract available.
PubMed 30878250Szilagyi PG, Schaffer S, Rand CM, Goldstein NPN, Younge M, Mendoza M, Albertin CS, Concannon C, Graupman E, Hightower AD, Yoo BK, Humiston SG. Text Message Reminders for Child Influenza Vaccination in the Setting of School-Located Influenza Vaccination: A Randomized Clinical Trial. Clin Pediatr (Phila). 2019 Apr;58(4):428-436. doi: 10.1177/0009922818821878. Epub 2019 Jan 2.
PubMed 30600690Szilagyi PG, Schaffer S, Rand CM, Goldstein NPN, Vincelli P, Hightower AD, Younge M, Eagan A, Blumkin A, Albertin CS, DiBitetto K, Yoo BK, Humiston SG. School-located Influenza Vaccinations for Adolescents: A Randomized Controlled Trial. J Adolesc Health. 2018 Feb;62(2):157-163. doi: 10.1016/j.jadohealth.2017.09.021. Epub 2017 Dec 13.
PubMed 29248390Szilagyi PG, Schaffer S, Rand CM, Vincelli P, Eagan A, Goldstein NP, Hightower AD, Younge M, Blumkin A, Albertin CS, Yoo BK, Humiston SG. School-Located Influenza Vaccinations: A Randomized Trial. Pediatrics. 2016 Nov;138(5):e20161746. doi: 10.1542/peds.2016-1746.
PubMed 27940785
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Effectiveness of a School-located Influenza Vaccination Program in Raising Influenza Vaccination Rates
- ClinicalTrials.gov ID
- NCT02227186
- Acronym / sponsor ID
- SKIPP RCT / 5R18HS021163
- Keywords
- Influenza vaccination rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,461 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 31 Jul 2015 (actual)
- Study completion
- 31 Jul 2015 (actual)
- First posted
- 28 Aug 2014 (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.
Children in schools in which influenza vaccination clinics are held during school hours will have higher rates of influenza vaccination than children in control schools (no school-located clinics offered)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –No school-located influenza vaccination clinic |
| School-located influenza vaccination clinics | Experimental | Other: School-located Influenza Vaccination ClinicSchool-located influenza vaccination clinics |
Who may qualify
- Ages
- 4 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Enrolled in participating, randomized school
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| School-located Influenza Vaccination ClinicChildren in the intervention arm are enrolled in schools in Monroe County, NY that are offering school-located influenza vaccination clinics during school hours | Other | School-located influenza vaccination clinics |
Primary outcome
Influenza vaccination status
Time frame: Within one year
Vaccination status for the 2014/2015 influenza season will be assessed. The vaccination date will be recorded, as well as the provider name, to determine whether vaccine was received at the school-located influenza clinic
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 1 May 2017.
- Derived from this study: PubMed 31234842Yoo BK, Schaffer SJ, Humiston SG, Rand CM, Goldstein NPN, Albertin CS, Concannon C, Szilagyi PG. Cost effectiveness of school-located influenza vaccination programs for elementary and secondary school children. BMC Health Serv Res. 2019 Jun 24;19(1):407. doi: 10.1186/s12913-019-4228-5.
- Derived from this study: PubMed 30878250Schaffer SJ, Rand CM, Humiston SG, Concannon C, Hightower AD, Albertin C, Szilagyi PG. Practical considerations in developing a successful school-located influenza vaccination (SLIV) program. Vaccine. 2019 Apr 10;37(16):2171-2173. doi: 10.1016/j.vaccine.2019.01.088. Epub 2019 Mar 13. No abstract available.
- Derived from this study: PubMed 30600690Szilagyi PG, Schaffer S, Rand CM, Goldstein NPN, Younge M, Mendoza M, Albertin CS, Concannon C, Graupman E, Hightower AD, Yoo BK, Humiston SG. Text Message Reminders for Child Influenza Vaccination in the Setting of School-Located Influenza Vaccination: A Randomized Clinical Trial. Clin Pediatr (Phila). 2019 Apr;58(4):428-436. doi: 10.1177/0009922818821878. Epub 2019 Jan 2.
- Derived from this study: PubMed 29248390Szilagyi PG, Schaffer S, Rand CM, Goldstein NPN, Vincelli P, Hightower AD, Younge M, Eagan A, Blumkin A, Albertin CS, DiBitetto K, Yoo BK, Humiston SG. School-located Influenza Vaccinations for Adolescents: A Randomized Controlled Trial. J Adolesc Health. 2018 Feb;62(2):157-163. doi: 10.1016/j.jadohealth.2017.09.021. Epub 2017 Dec 13.
- Derived from this study: PubMed 27940785Szilagyi PG, Schaffer S, Rand CM, Vincelli P, Eagan A, Goldstein NP, Hightower AD, Younge M, Blumkin A, Albertin CS, Yoo BK, Humiston SG. School-Located Influenza Vaccinations: A Randomized Trial. Pediatrics. 2016 Nov;138(5):e20161746. doi: 10.1542/peds.2016-1746.
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 Szilagyi, MPH, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School-located Influenza Vaccination Clinic in people with Childhood Influenza Vaccination and School-located Influenza Vaccination, run by University of California, Los Angeles 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 1 May 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?
Influenza vaccination status (time frame: Within one year). 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 NCT02227186, which also lists 5 linked publications.
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 1 May 2017.