InfluenzaNCT06603090
Text4Vax: Text Message Reminders for Pediatric COVID-19 and Influenza Vaccines 2024-25 Season
A study testing Text message influenza vaccine reminders, Text message COVID-19 vaccine reminders and Text message influenza and COVID-19 vaccine reminders in people with Influenza and COVID-19, run by Columbia University at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Influenza, COVID-19, Vaccination Hesitancy
- What is being tested?
- Text message influenza vaccine reminders, Text message COVID-19 vaccine reminders and Text message influenza and COVID-19 vaccine reminders
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66,147 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Oct 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Has opted out of text messages from practice
- Language listed in electronic health record is not English or Spanish
Trial locations and contacts
4 sites in 1 country.
United States4 sites
American Academy of Pediatrics
Itasca, Illinois, 60143
Columbia University Irving Medical Center
New York, New York, 10032
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Influenza, COVID-19, Vaccination Hesitancy
- Being tested
- Text message influenza vaccine reminders, Text message COVID-19 vaccine reminders, Text message influenza and COVID-19 vaccine reminders
- Keywords
- text message, Short message service (SMS), mHealth
- Medical subject headings
- Influenza, Human, COVID-19, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message influenza vaccine remindersBehavioural
Text message influenza vaccine reminders
Text message COVID-19 vaccine remindersBehavioural
Text message COVID-19 vaccine reminders
Text message influenza and COVID-19 vaccine remindersBehavioural
Text message influenza and COVID-19 vaccine reminders
| Study group | Role | What they receive |
|---|---|---|
| Text message influenza and COVID-19 vaccine reminders | Experimental | Text message reminders for both influenza and COVID-19 vaccinations Receives: Behavioral: Text message influenza and COVID-19 vaccine reminders |
| Text message influenza vaccine reminders | Experimental | Text message reminders only for influenza vaccination Receives: Behavioral: Text message influenza vaccine reminders |
| Text message COVID-19 vaccine reminders | Experimental | Text message reminders only for COVID-19 vaccination Receives: Behavioral: Text message COVID-19 vaccine reminders |
| Usual Care | No intervention | Usual care has no text message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeliness of influenza vaccination
Days from study start to influenza vaccine up to December 31 each year
Measured: Up to December 31 each year, up to ~90 days
Timeliness of COVID-19 vaccination
Days from study start to COVID-19 vaccine up to December 31 each year
Measured: Up to December 31 each year, up to ~90 days
Secondary outcomes (6)
Timeliness of influenza vaccination
Days from study start to influenza vaccine up to April 30 each year
Measured: Up to April 30 each year, up to ~210 days
Timeliness of COVID-19 vaccination
Days from study start to COVID-19 vaccine up to April 30 each year
Measured: Up to April 30 each year, up to ~210 days
Percentage of Participants Who Received Influenza Vaccine by December 31 Each Year
Receipt of influenza vaccine by December 31 each year
Measured: ~3 months
Percentage of Participants Who Received COVID-19 Vaccine by December 31 Each Year
Receipt of COVID-19 vaccine by December 31 each year
Measured: ~3 months
Percentage of Participants Who Received Influenza Vaccine by April 30 Each Year
Receipt of influenza vaccine by April 30 each year
Measured: ~7 months
Percentage of Participants Who Received COVID-19 Vaccine by April 30 Each Year
Receipt of COVID-19 vaccine by April 30 each year
Measured: ~7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Oct 2024
- Primary completion31 Dec 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 66,147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, American Academy of Pediatrics, University of Pennsylvania, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Melissa Stockwell, Columbia University
- Investigators
- Melissa Stockwell, MD MPH, Principal investigator, Columbia UniversityAlex Fiks, MD MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603090
- Sponsor's protocol ID
- AAAV0563-01
- Other IDs
- 1R01AI182165
- Status last verified
- Jul 2025
- First submitted
- 17 Sep 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text4Vax: Understanding the Effectiveness and Implementation of Text Message Reminders for Pediatric COVID-19 and Influenza Vaccines 2024-2025 Season
- ClinicalTrials.gov ID
- NCT06603090
- Acronym / sponsor ID
- AAAV0563-01
- Conditions
- Influenza, COVID-19, Vaccination Hesitancy
- Keywords
- text message, Short message service (SMS), mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66,147 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, American Academy of Pediatrics, University of Pennsylvania, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Text message influenza and COVID-19 vaccine reminders | Experimental | Behavioral: Text message influenza and COVID-19 vaccine remindersText message reminders for both influenza and COVID-19 vaccinations |
| Text message influenza vaccine reminders | Experimental | Behavioral: Text message influenza vaccine remindersText message reminders only for influenza vaccination |
| Text message COVID-19 vaccine reminders | Experimental | Behavioral: Text message COVID-19 vaccine remindersText message reminders only for COVID-19 vaccination |
| Usual Care | No intervention | –Usual care has no text message |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child that:
- Receives care at study site
- Language listed in electronic health record is English or Spanish
- Has not opted out of text messages from practice
Key exclusion criteria (2 listed)
- Has opted out of text messages from practice
- Language listed in electronic health record is not English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text message influenza vaccine remindersText message influenza vaccine reminders | Behavioural | Text message influenza vaccine reminders |
| Text message COVID-19 vaccine remindersText message COVID-19 vaccine reminders | Behavioural | Text message COVID-19 vaccine reminders |
| Text message influenza and COVID-19 vaccine remindersText message influenza and COVID-19 vaccine reminders | Behavioural | Text message influenza and COVID-19 vaccine reminders |
Primary outcome
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
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
6 secondary outcomes
Timeliness of influenza vaccination
Time frame: 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
Percentage of Participants Who Received Influenza Vaccine by December 31 Each Year
Time frame: ~3 months
Percentage of Participants Who Received COVID-19 Vaccine by December 31 Each Year
Time frame: ~3 months
Percentage of Participants Who Received Influenza Vaccine by April 30 Each Year
Time frame: ~7 months
Percentage of Participants Who Received COVID-19 Vaccine by April 30 Each Year
Time frame: ~7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Stockwell, MD MPH principal investigator
Columbia University
Alex Fiks, MD MSCE principal investigator
Children's Hospital of Philadelphia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message influenza vaccine reminders, Text message COVID-19 vaccine reminders and Text message influenza and COVID-19 vaccine reminders in people with Influenza and COVID-19, run by Columbia University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timeliness of influenza vaccination (time frame: Up to December 31 each year, up to ~90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.