SAVE: School Ambassadors for Vaccine Education

NCT ID: NCT07164144

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-09-01

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]

Conditions

Immunization; Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Vaccine Communication Training

Intervention Type: BEHAVIORAL

School personnel receive vaccine communication training + promotional materials

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vaccine Communication Training

School personnel receive vaccine communication training + promotional materials

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Cynthia Rand

Professor, Pediatrics & Division Chief, General Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

STUDY00010895

Identifier Type: -

Identifier Source: org_study_id