Influenza
Conditions
Keywords
Influenza, influenza vaccination, school-based vaccination
Brief summary
Rates of confirmed influenza illness in vaccinated and non-vaccinated children will be compared between schools with and without vaccination programs. The investigators hypothesize that in addition to lowering rates of influenza in vaccinated children, raising vaccination rates by 30-40% through school-based vaccination programs will decrease incidence of influenza in non-vaccinated children attending those schools compared to non-vaccinated children in schools with low vaccination rates.
Detailed description
This prospective cohort study will evaluate rates of virologically confirmed influenza in children attending schools with and without school-based vaccination programs. Eight schools (4455 students) in two school districts matched for size, race/ethnicity, socioeconomic status, and location will serve as intervention and control schools. During influenza season defined by local surveillance data, nasal/throat swabs will be obtained for rapid influenza detection assays from all children with fever and respiratory symptoms identified by teachers for evaluation in the school nurse's office. Absent children will be offered testing at a central location within the schools' communities.Rates of confirmed influenza illness in vaccinated and non-vaccinated children will be compared between schools with and without vaccination programs. Rates of absenteeism also will be evaluated. The investigators hypothesize that in addition to lowering rates of influenza in vaccinated children, raising vaccination rates by 30-40% through school-based vaccination programs will decrease incidence of influenza in non-vaccinated children attending those schools compared to non-vaccinated children in schools with low vaccination rates.
Interventions
BIOLOGICALSchool-based influenza vaccination program
School-based influenza vaccination program
Sponsors
Los Angeles County Department of Public Health
Children's Hospital Los Angeles
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children enrolled in target schools
Exclusion criteria
none
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs | 1 year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Intervention No school-based influenza vaccination program | 2,087 |
| Intervention School-based Influenza Vaccination Program
School-based influenza vaccination program: School-based influenza vaccination program | 2,368 |
| Total | 4,455 |
Baseline characteristics
| Characteristic | Intervention | No Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2368 Participants | 2087 Participants | 4455 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.3 years | 8.2 years | 8.3 years |
| Region of Enrollment United States | 2368 participants | 2087 participants | 4455 participants |
| Sex: Female, Male Female | 1146 Participants | 987 Participants | 2133 Participants |
| Sex: Female, Male Male | 1222 Participants | 1100 Participants | 2322 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2,087 | 0 / 2,368 |
| serious Total, serious adverse events | 0 / 2,087 | 0 / 2,368 |
Outcome results
Primary
Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Intervention | Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs | 58.0 flu+ per 1000 children |
| Intervention | Rates of Confirmed Influenza Illness in Vaccinated and Non-vaccinated Children Attending Schools With and Without School-based Influenza Vaccination Programs | 40.1 flu+ per 1000 children |
Secondary
Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Intervention | Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs | 4.2 days per 100 school days | Standard Deviation 4.7 |
| Intervention | Rates of Absenteeism Among Children Attending Schools With and Without School-based Influenza Vaccination Programs | 3.9 days per 100 school days | Standard Deviation 4.8 |