School Located Vaccine ProgramNCT01719679
School Located Adolescent Vaccination Study
A study testing School Located Vaccine (SLV) Program in people with School Located Vaccine Program, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The provision of adolescent vaccination in a school setting will be feasible and acceptable to parents as evidenced by the number and percentage of students immunized within each school compared to those in schools without a program. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- School Located Vaccine Program
- What is being tested?
- School Located Vaccine (SLV) Program
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Oct 2011
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 2000 (1000 at intervention schools and 1000 in control schools) randomly selected students enrolled in 6th - 8th grade at randomly selected schools
- students who appear to be in need of one or more immunizations of interest at the beginning of the school year
- students enrolled in school by October 1st registration deadline will be included in the analysis
Who cannot join
- students who appear to have had all immunizations of interest at the beginning of the school year
- students enrolled after the October 1 school registration deadline will be excluded from the analysis
- students enrolled in grades other than 6th, 7th, or 8th grade will not be eligible to participate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver
Aurora, Colorado, 80045
Kaiser Permanente Colorado
Denver, Colorado, 80231
About this study
Official title: Examination of the Effectiveness of Adolescent Vaccines Given in Schools
The provision of adolescent vaccination in a school setting will be feasible and acceptable to parents as evidenced by the number and percentage of students immunized within each school compared to those in schools without a program. The likelihood of vaccination for diphtheria, tetanus, and pertussis (Tdap), human papillomavirus (HPV), and meningococcal conjugate vaccine (MCV4) and all three combined) among eligible students enrolled in schools with a comprehensive school-based immunization program will be significantly higher than that of students enrolled in schools without a school-based immunization program.
- Conditions
- School Located Vaccine Program
- Being tested
- School Located Vaccine (SLV) Program
- Keywords
- school located vaccine program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School Located Vaccine (SLV) ProgramBehavioural
A community vaccinator will administer vaccines to students whose parents consent for their child to participate
| Study group | Role | What they receive |
|---|---|---|
| School Located Vaccine (SLV) Program | Experimental | A vaccine program carried out by a community vaccinator will be conducted in a limited number of participating schools. The program will be open to the students enrolled at the participating schools Receives: Behavioral: School Located Vaccine (SLV) Program |
| no School Located Vaccine (SLV) Program | No intervention | Schools that are part of the non-intervention arm of the study will not have a school-located vaccine program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The likelihood of vaccination among eligible 6th grade students with one or more needed vaccines in intervention schools compared to control schools.
The vaccination status of eligible students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
Measured: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
The likelihood of vaccination among eligible 6th grade students with Tdap vaccine in intervention schools compared to control schools.
The Tdap vaccination status of eligible students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
Measured: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
The likelihood of vaccination among eligible 6th grade students with MCV4 vaccine in intervention schools compared to control schools.
The MCV4 vaccination status of eligible students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
Measured: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
The likelihood of vaccination among eligible 6th grade female students with HPV vaccine in intervention schools compared to control schools.
The HPV vaccination status of eligible female students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
Measured: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
Secondary outcomes (4)
The likelihood of vaccination with Tdap vaccine among eligible 7th and 8th grade students enrolled at intervention schools compared to control schools.
The Tdap vaccination status of students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
Measured: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
The likelihood of vaccination with one or more HPV vaccines among eligible 7th and 8th grade female students enrolled in intervention schools compared to control schools.
The HPV vaccination status of eligible female students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
Measured: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
The likelihood of MCV4 vaccination among eligible 7th and 8th students enrolled in intervention schools compared to control schools.
The MCV4 vaccination status of eligible 7th and 8th grade students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
Measured: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
The likelihood of HPV vaccine series completion among female students in intervention schools compared to control schools.
The HPV vaccine status of female students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
Measured: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startAug 2010
- Primary completionAug 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for School Located Vaccine ProgramStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Judy Shlay, MD, MSPH, Principal investigator, Denver Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719679
- Sponsor's protocol ID
- 08-0204
- Status last verified
- Sep 2012
- First submitted
- 30 Oct 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Effectiveness of Adolescent Vaccines Given in Schools
- ClinicalTrials.gov ID
- NCT01719679
- Acronym / sponsor ID
- 08-0204
- Conditions
- School Located Vaccine Program
- Keywords
- school located vaccine program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 1 Nov 2012 (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.
The provision of adolescent vaccination in a school setting will be feasible and acceptable to parents as evidenced by the number and percentage of students immunized within each school compared to those in schools without a program. The likelihood of vaccination for diphtheria, tetanus, and pertussis (Tdap), human papillomavirus (HPV), and meningococcal conjugate vaccine (MCV4) and all three combined) among eligible students enrolled in schools with a comprehensive school-based immunization program will be significantly higher than that of students enrolled in schools without a school-based immunization program.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| School Located Vaccine (SLV) Program | Experimental | Behavioral: School Located Vaccine (SLV) ProgramA vaccine program carried out by a community vaccinator will be conducted in a limited number of participating schools. The program will be open to the students enrolled at the participating schools |
| no School Located Vaccine (SLV) Program | No intervention | –Schools that are part of the non-intervention arm of the study will not have a school-located vaccine program. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 2000 (1000 at intervention schools and 1000 in control schools) randomly selected students enrolled in 6th - 8th grade at randomly selected schools
- students who appear to be in need of one or more immunizations of interest at the beginning of the school year
- students enrolled in school by October 1st registration deadline will be included in the analysis
Key exclusion criteria (3 listed)
- students who appear to have had all immunizations of interest at the beginning of the school year
- students enrolled after the October 1 school registration deadline will be excluded from the analysis
- students enrolled in grades other than 6th, 7th, or 8th grade will not be eligible to participate
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 Vaccine (SLV) ProgramA community vaccinator will administer vaccines to students whose parents consent for their child to participate | Behavioural | School Located Vaccine (SLV) Program |
Primary outcome
The likelihood of vaccination among eligible 6th grade students with one or more needed vaccines in intervention schools compared to control schools.
Time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
The vaccination status of eligible students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
The likelihood of vaccination among eligible 6th grade students with Tdap vaccine in intervention schools compared to control schools.
Time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
The Tdap vaccination status of eligible students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
The likelihood of vaccination among eligible 6th grade students with MCV4 vaccine in intervention schools compared to control schools.
Time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
The MCV4 vaccination status of eligible students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
The likelihood of vaccination among eligible 6th grade female students with HPV vaccine in intervention schools compared to control schools.
Time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
The HPV vaccination status of eligible female students enrolled at participating schools will be assessed at the beginning of the school year and at the end of the school year using immunization data from the school, the state registry, community vaccinator registry, and parent records. The assessment will occur in both intervention and control settings.
4 secondary outcomes
The likelihood of vaccination with Tdap vaccine among eligible 7th and 8th grade students enrolled at intervention schools compared to control schools.
Time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
The likelihood of vaccination with one or more HPV vaccines among eligible 7th and 8th grade female students enrolled in intervention schools compared to control schools.
Time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
The likelihood of MCV4 vaccination among eligible 7th and 8th students enrolled in intervention schools compared to control schools.
Time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
The likelihood of HPV vaccine series completion among female students in intervention schools compared to control schools.
Time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011
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 3 Jan 2013.
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.
Judy Shlay, MD, MSPH principal investigator
Denver Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School Located Vaccine (SLV) Program in people with School Located Vaccine Program, run by University of Colorado, Denver at 2 sites 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 3 inclusion and 3 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 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The likelihood of vaccination among eligible 6th grade students with one or more needed vaccines in intervention schools compared to control schools. (time frame: end of the school year 2010 - 2011 compared to beginning of school year 2010 - 2011). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2013.