NCT07164144

Brief Summary

Influenza is associated with millions of cases of school absenteeism due to illness, hundreds of hospitalizations and thousands of deaths in the U.S. each year, which can be greatly reduced with influenza vaccination. The goal of this randomized controlled trial is to learn if training school personnel in vaccine communication techniques and equipping schools with vaccine promotional materials targeting students and their parents/guardians increases the influenza vaccination rates of the student population within participating schools. The main question it aims to answer is:

  • Will flu vaccination rates be higher in intervention schools compared to control schools by the end of the intervention period? Participating schools will:
  • Have select school personnel (school nurses, coaches, teachers, etc.) complete an online training module and optional training workshop focused on vaccine communication \[intervention arm only\]
  • Utilize vaccine promotional materials (posters, flyers, digital files for social media, etc.) provided by the study team during flu season \[intervention arm only\]
  • Track student vaccination rates \[intervention + control arm\]

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Sep 2027

First Submitted

Initial submission to the registry

August 27, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

August 27, 2025

Last Update Submit

March 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Flu vaccination rate

    8 months (one flu season August-March)

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Vaccine Communication Training

Control

NO INTERVENTION

Interventions

School personnel receive vaccine communication training + promotional materials

Intervention

Eligibility Criteria

Age5 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • A student enrolled in a participating school (intervention or control) for at least two years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Schools

Rochester, New York, 14614, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Pediatrics & Division Chief, General Pediatrics

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 9, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations