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

NCT ID: NCT06603090

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-02

Study Completion Date

2025-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza COVID-19 Vaccination Hesitancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Text message influenza and COVID-19 vaccine reminders

Text message reminders for both influenza and COVID-19 vaccinations

Group Type EXPERIMENTAL

Text message influenza and COVID-19 vaccine reminders

Intervention Type BEHAVIORAL

Text message influenza and COVID-19 vaccine reminders

Text message influenza vaccine reminders

Text message reminders only for influenza vaccination

Group Type EXPERIMENTAL

Text message influenza vaccine reminders

Intervention Type BEHAVIORAL

Text message influenza vaccine reminders

Text message COVID-19 vaccine reminders

Text message reminders only for COVID-19 vaccination

Group Type EXPERIMENTAL

Text message COVID-19 vaccine reminders

Intervention Type BEHAVIORAL

Text message COVID-19 vaccine reminders

Usual Care

Usual care has no text message

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Text message influenza vaccine reminders

Text message influenza vaccine reminders

Intervention Type BEHAVIORAL

Text message COVID-19 vaccine reminders

Text message COVID-19 vaccine reminders

Intervention Type BEHAVIORAL

Text message influenza and COVID-19 vaccine reminders

Text message influenza and COVID-19 vaccine reminders

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

American Academy of Pediatrics

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Melissa Stockwell

Professor of Pediatrics; Professor of Population and Family Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Melissa Stockwell, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Alex Fiks, MD MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

American Academy of Pediatrics

Itasca, Illinois, United States

Site Status

Columbia University Irving Medical Center

New York, New York, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01AI182165

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAV0563-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

NeisVac-C Single Prime Study in Infants
NCT01218451 COMPLETED PHASE3