Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138294
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2005-08-26
Brief Title:
Control of Epidemic Influenza Through a School-based Influenza Vaccination Program
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Phase 4 School-based Open-labeled Research Trial for Control of Epidemic Influenza Through a School-based Influenza Vaccination Program in Central Texas
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CEI
Brief Summary:
The main purpose of this study is to learn if influenza vaccines live attenuated and inactivated influenza vaccines when given to school-aged children 4 to 18 years of age can stop or lessen the influenza flu outbreak in the community Another purpose is to show that vaccination of these children will significantly reduce breathing problems in the vaccinated children and unvaccinated people they come in contact with in the community that require a visit to the doctor for treatment Another purpose is to continue to collect safety and flu protection information on live attenuated influenza vaccine LAIV or FluMist given to children The study investigators believe that vaccination of healthy school-aged children is an effective plan for preventing many people in the community from catching the flu Children will take part in the study for 5 to 10 months
Detailed Description:
This study was conducted in three phases The first phase spanned from 1998-2003 PubMed ID14706961 PubMed ID 12915495 and the second phase spanned from 2003-2007 PubMedID 18401289 PubMed ID 17698577 The final phase of the study spanned 2007-2011 and is the scope of this submission
The goal of the final phase is to control epidemic influenza through active immunization of healthy school-aged children with the cold-adapted trivalent live attenuated influenza vaccine LAIV and at-risk children with the inactivated influenza vaccine IIV through a school-based vaccination program
The hypothesis is that universal vaccination of healthy school-aged children is an alternative and effective strategy for the control of epidemic influenza and will serve as a model for the control of pandemic influenza and biodefense The specific aims of the study are to control the spread of influenza to susceptible adults 35 years of age or older by vaccination of school-aged children 4-18 years of age to control the spread of influenza to susceptible children and young adults less than 35 years of age by vaccination of school-aged children 4-18 years of age to develop a school-based vaccination program for rapid and timely delivery of LAIV and IIV to children 4-18 years of age to demonstrate in school-aged children the direct and total effectiveness of influenza vaccines to reduce the rates of medically attended acute respiratory illness MAARI in LAIV and IIV recipients during influenza epidemics and to capture safety information on LAIV post-licensure
This is an open-label up to four year community-based study In each of the first three study years school-aged children 4 through 18 years of age who receive medical care at the Scott White Clinics SWCs Temple-Belton area Texas will be asked to participate in this study Study participants will receive LAIV or IIV according to their health status Other children from Temple-Belton area who do not receive medical care at the SWC will be invited to participate in the study and may receive LAIV or IIV A comparable population enrolled in the SWCs in WacoMcLennan County area and BryanCollege Station will serve as comparison groups
In the fourth and final year of the study LAIV will not be provided through the study However influenza surveillance will continue and MAARI data will be collected to assess continued protective benefit of influenza vaccines The final year will also be devoted to completion of data analysis and preparation of manuscripts
Children 4 years through 8 years who have not previously been vaccinated with an influenza vaccine will be offered a second dose 4 to 6 weeks after the first dose The influenza vaccines will contain the three influenza virus strains chosen by the FDA Each subject will receive by nasal spray a 02 ml dose 01 ml in each nostril of the LAIV or 05 ml intramuscularly
The duration of each study year is approximately five to ten months from the time of enrollment August to January at the discretion of the investigators depending on vaccine availability and the timing of influenza activity to the end of the influenza season May
The goal of the final phase is to control epidemic influenza through active immunization of healthy school-aged children with the cold-adapted trivalent live attenuated influenza vaccine LAIV and at-risk children with the inactivated influenza vaccine IIV through a school-based vaccination program
The hypothesis is that universal vaccination of healthy school-aged children is an alternative and effective strategy for the control of epidemic influenza and will serve as a model for the control of pandemic influenza and biodefense The specific aims of the study are to control the spread of influenza to susceptible adults 35 years of age or older by vaccination of school-aged children 4-18 years of age to control the spread of influenza to susceptible children and young adults less than 35 years of age by vaccination of school-aged children 4-18 years of age to develop a school-based vaccination program for rapid and timely delivery of LAIV and IIV to children 4-18 years of age to demonstrate in school-aged children the direct and total effectiveness of influenza vaccines to reduce the rates of medically attended acute respiratory illness MAARI in LAIV and IIV recipients during influenza epidemics and to capture safety information on LAIV post-licensure
This is an open-label up to four year community-based study In each of the first three study years school-aged children 4 through 18 years of age who receive medical care at the Scott White Clinics SWCs Temple-Belton area Texas will be asked to participate in this study Study participants will receive LAIV or IIV according to their health status Other children from Temple-Belton area who do not receive medical care at the SWC will be invited to participate in the study and may receive LAIV or IIV A comparable population enrolled in the SWCs in WacoMcLennan County area and BryanCollege Station will serve as comparison groups
In the fourth and final year of the study LAIV will not be provided through the study However influenza surveillance will continue and MAARI data will be collected to assess continued protective benefit of influenza vaccines The final year will also be devoted to completion of data analysis and preparation of manuscripts
Children 4 years through 8 years who have not previously been vaccinated with an influenza vaccine will be offered a second dose 4 to 6 weeks after the first dose The influenza vaccines will contain the three influenza virus strains chosen by the FDA Each subject will receive by nasal spray a 02 ml dose 01 ml in each nostril of the LAIV or 05 ml intramuscularly
The duration of each study year is approximately five to ten months from the time of enrollment August to January at the discretion of the investigators depending on vaccine availability and the timing of influenza activity to the end of the influenza season May
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AI041050 | NIH | Scott and White | httpsreporternihgovquickSearchR01AI041050 |
| Flu-035-09 | OTHER | None | None |
| BCM H-21853 | OTHER | None | None |
| SW070912 | OTHER | None | None |