Text4Vax: Text Message Reminders for Pediatric COVID-19 and Influenza Vaccines 2024-25 Season

July 9, 2025 updated by: Melissa Stockwell, Columbia University

Text4Vax: Understanding the Effectiveness and Implementation of Text Message Reminders for Pediatric COVID-19 and Influenza Vaccines 2024-2025 Season

This multi-site study assesses the impact of text message reminders on the receipt of COVID-19 and influenza text message reminders takes place primarily in practices from the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) network.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is to be conducted over the 1st season (September 2024-April 2025) as an effectiveness trial and the 2nd (September 2025-April 2026) as a replication study. This protocol covers the first season. Parents of eligible children who are 6 month-17 year-old who are due for both a COVID-19 and influenza vaccine will be sent text messages. Within each practice site, parents of eligible children will be randomized to receive either: 1) combined COVID-19 and influenza vaccine text message reminders, 2) COVID-19 reminders alone, 3) influenza reminders alone, or 4) no reminders (usual care).

Randomization is to be stratified by practice site, age group and prior year's COVID-19/influenza vaccine history. Messages will be sent centrally and managed by the research team.

Study Type

Interventional

Enrollment (Actual)

66147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Itasca, Illinois, United States, 60143
        • American Academy of Pediatrics
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Child that:

    • is 6 months-17 year-old children
    • due for both a COVID-19 and influenza vaccine
  • Receives care at study site
  • Language listed in electronic health record is English or Spanish
  • Has not opted out of text messages from practice

Exclusion Criteria:

  • Has opted out of text messages from practice
  • Language listed in electronic health record is not English or Spanish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Text message influenza and COVID-19 vaccine reminders
Text message reminders for both influenza and COVID-19 vaccinations
Behavioral: Text message influenza and COVID-19 vaccine reminders
Text message influenza and COVID-19 vaccine reminders
Experimental: Text message influenza vaccine reminders
Text message reminders only for influenza vaccination
Behavioral: Text message influenza vaccine reminders
Text message influenza vaccine reminders
Experimental: Text message COVID-19 vaccine reminders
Text message reminders only for COVID-19 vaccination
Behavioral: Text message COVID-19 vaccine reminders
Text message COVID-19 vaccine reminders
No Intervention: Usual Care
Usual care has no text message

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timeliness of influenza vaccination
Time Frame: Up to December 31 each year, up to ~90 days
Days from study start to influenza vaccine up to December 31 each year
Up to December 31 each year, up to ~90 days
Timeliness of COVID-19 vaccination
Time Frame: Up to December 31 each year, up to ~90 days
Days from study start to COVID-19 vaccine up to December 31 each year
Up to December 31 each year, up to ~90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timeliness of influenza vaccination
Time Frame: Up to April 30 each year, up to ~210 days
Days from study start to influenza vaccine up to April 30 each year
Up to April 30 each year, up to ~210 days
Timeliness of COVID-19 vaccination
Time Frame: Up to April 30 each year, up to ~210 days
Days from study start to COVID-19 vaccine up to April 30 each year
Up to April 30 each year, up to ~210 days
Percentage of Participants Who Received Influenza Vaccine by December 31 Each Year
Time Frame: ~3 months
Receipt of influenza vaccine by December 31 each year
~3 months
Percentage of Participants Who Received COVID-19 Vaccine by December 31 Each Year
Time Frame: ~3 months
Receipt of COVID-19 vaccine by December 31 each year
~3 months
Percentage of Participants Who Received Influenza Vaccine by April 30 Each Year
Time Frame: ~7 months
Receipt of influenza vaccine by April 30 each year
~7 months
Percentage of Participants Who Received COVID-19 Vaccine by April 30 Each Year
Time Frame: ~7 months
Receipt of COVID-19 vaccine by April 30 each year
~7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Children's Hospital of Philadelphia
University of Pennsylvania
American Academy of Pediatrics

Investigators

  • Principal Investigator: Melissa Stockwell, MD MPH, Columbia University
  • Principal Investigator: Alex Fiks, MD MSCE, Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAV0563-01
  • 1R01AI182165 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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