Influenza Clinical Trial
Official title:
Pittsburgh Influenza Prevention Project
The purpose of this study is to understand the spread of influenza (flu) in schools and households with elementary (K-5) school children, and develop ways to reduce the flu using non-pharmaceutical means.
Pandemic influenza threatens to cause substantial disability, death, and societal disruption
and to overwhelm health care systems in the United States and around the world. Because
effective vaccines may not be available during the initial months of a pandemic, and because
anti-viral medication is both largely ineffective and in short supply, non-pharmacological
personal protection and behavioral changes may be the only means to combat the epidemic. In
our computational modeling work (through the Models of Infectious Disease Agent Study
network), we have shown the potential value of multiple targeted and layered
non-pharmacological interventions in blunting the peak impact and slowing of a pandemic
(Nature, in press).
Phase 1 of the project will be a pilot study in two elementary schools in the City of
Pittsburgh. The project has already obtained agreement to collaborate from the Pittsburgh
Public School System and we have assembled a multi-disciplinary team of epidemiologists,
systems analysts, modelers, community and minority health workers, and virologists to
implement the project. Phase one was in 2 schools.
Phase 2 will be similar to Phase 1 with the addition of additional schools and application
of a "hygiene" intervention to selected schools and families. Phase 2 is in 10 schools with
3800 students.
Specific aims (year 02):
Primary
1. Measure the effectiveness of non-pharmaceutical interventions (NPIs) in reducing
influenza rates among enrolled students in the intervention and control schools when
influenza is known to be circulating in the community. [Note: Enrolled, for purposes of
PIPP, will indicate students who present with ILI, consent to participate, and are
tested for influenza during the flu season.] Secondary: School-Based
2. Measure number of absentees and determine the reason for absence by using a school
based absentee illness surveillance system prior to and through the end of influenza
season.
3. Measure the effectiveness of NPIs in reducing absenteeism from all causes, including
illness/URI, illness/ILI, illness/other, and illness/GI through the end of influenza
season.
4. Measure the effectiveness of NPIs in reducing secondary spread of ILI within classrooms
of participating schools.
5. Assess adoption of NPI behaviors and activities in classrooms of intervention schools.
Secondary: Home-Based
6. Measure the effectiveness of NPIs in reducing secondary cases of ILI within families of
enrolled school children with influenza.
7. Assess adherence of families of enrolled school children with influenza to
isolation-related NPI behaviors and activities.
Tertiary
8. Measure correlation between rapid flu testing and PCR testing for influenza.
9. Collect and archive influenza specimens for future molecular epidemiological studies.
10. Contribute a sample of influenza-positive specimens to the CDC for national influenza
surveillance purposes.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05523089 -
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
|
Phase 2 | |
Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
Completed |
NCT03282240 -
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
|
Phase 3 | |
Completed |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
Phase 3 | |
Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
Completed |
NCT04695717 -
This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam
|
Phase 3 | |
Completed |
NCT05012163 -
Lottery Incentive Nudges to Increase Influenza Vaccinations
|
N/A | |
Completed |
NCT04109222 -
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
|
Phase 4 | |
Completed |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
Completed |
NCT02587221 -
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
|
Phase 3 | |
Completed |
NCT03453801 -
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
|
Phase 1 | |
Completed |
NCT01440387 -
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
|
Phase 3 | |
Terminated |
NCT01195779 -
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
|
Phase 2 | |
Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
Completed |
NCT00972517 -
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
|
Phase 3 | |
Completed |
NCT04570904 -
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
|
||
Recruiting |
NCT03331991 -
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
|
N/A |