Trial Outcomes & Findings for Study to Evaluate Impact of School-based Influenza Vaccination on School Populations (NCT NCT00844051)
NCT ID: NCT00844051
Last Updated: 2016-09-12
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4455 participants
Primary outcome timeframe
1 year
Results posted on
2016-09-12
Participant Flow
Participant milestones
| Measure |
No Intervention
No school-based influenza vaccination program
|
Intervention
School-based Influenza Vaccination Program
|
|---|---|---|
|
Overall Study
STARTED
|
2087
|
2368
|
|
Overall Study
COMPLETED
|
2087
|
2368
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Impact of School-based Influenza Vaccination on School Populations
Baseline characteristics by cohort
| Measure |
No Intervention
n=2087 Participants
No school-based influenza vaccination program
|
Intervention
n=2368 Participants
School-based Influenza Vaccination Program
School-based influenza vaccination program: School-based influenza vaccination program
|
Total
n=4455 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2087 Participants
n=5 Participants
|
2368 Participants
n=7 Participants
|
4455 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
8.2 years
n=5 Participants
|
8.3 years
n=7 Participants
|
8.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
987 Participants
n=5 Participants
|
1146 Participants
n=7 Participants
|
2133 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1100 Participants
n=5 Participants
|
1222 Participants
n=7 Participants
|
2322 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2087 participants
n=5 Participants
|
2368 participants
n=7 Participants
|
4455 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
No Intervention
n=2087 Participants
No school-based influenza vaccination program
|
Intervention
n=2368 Participants
School-based Influenza Vaccination Program
|
|---|---|---|
|
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
|
40.1 flu+ per 1000 children
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
No Intervention
n=2087 Participants
No school-based influenza vaccination program
|
Intervention
n=2368 Participants
School-based Influenza Vaccination Program
|
|---|---|---|
|
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
|
3.9 days per 100 school days
Standard Deviation 4.8
|
Adverse Events
No Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place