Pediatric ALLNCT04936776
Pediatric Vaccinations
An observational study of Pediatric ALL and Vaccination, run by NYU Langone Health at 1 site in United States.
Trial summary
As the Covid-19 pandemic hit New York City in the spring of 2020, many families were home-bound due to the city-wide lockdown. As a result, families in New York City were unable to attend their child's healthcare appointments and many young children did not receive their regularly-scheduled vaccinations. Read more about this study
- Who is it for?
- Ages 1 year to 2 years
- Conditions the study is for
- Pediatric ALL, Vaccination, Immunization
- What is being tested?
- Text messaging
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- How many people
- 1,034 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2021to 2 Jan 2024
- Phase
- Observational
- 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 1 year to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Children ages 0-2 years with delayed vaccinations (due for vaccine and due soon) in NYU Brooklyn Family Health Centers network.
Who may be able to join
- Children ages 0-2 years with delayed vaccinations (due for vaccine and due soon) in NYU Brooklyn Family Health Centers network.
Who cannot join
- Children above the age of 2 who do not attend NYU Brooklyn Family Health Centers network
Trial locations and contacts
1 site in 1 country.
About this study
As the Covid-19 pandemic hit New York City in the spring of 2020, many families were home-bound due to the city-wide lockdown. As a result, families in New York City were unable to attend their child's healthcare appointments and many young children did not receive their regularly-scheduled vaccinations. Parts of the city-wide lockdown did eventually lift in the summer of 2020 as positive Covid-19 virus rates declined in NYC. However, regularly scheduled vaccination rates (non-Covid-related) remain low. Yet, it is critical that young children receive their mandatory vaccines in a timely manner to decrease the chance of contracting preventable illnesses. Thus, the investigators seek to increase vaccination rates among children ages 0-2 years in Sunset Park Brooklyn.
- Conditions
- Pediatric ALL, Vaccination, Immunization
- Being tested
- Text messaging
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messagingBehavioural
Text parents of children (age 0-2yrs) who are due and due soon for a vaccine across the entire NYU-Brooklyn FHC network to increase vaccination rates.
| Study group | Role | What they receive |
|---|---|---|
| Text message 1 | Text messaging frame = safety and cleanness of clinic site. Text parents of children 0-2 years old who are due and due soon for a vaccine across the entire NYU-Brooklyn Family Health Center network. Receives: Behavioral: Text messaging | |
| Text message 2 | Text messaging frame = importance of vaccines. Text parents of children 0-2 years old who are due and due soon for a vaccine across the entire NYU-Brooklyn Family Health Center network. Receives: Behavioral: Text messaging | |
| No text message | No text sent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pediatric vaccination rate among children ages 0-2 years (proportion of vaccines due per person)
Measured: Baseline - 1 year
Secondary outcomes (1)
Number of scheduled appointments
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start9 Feb 2021
- Primary completion21 Dec 2023
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly Krelle, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936776
- Sponsor's protocol ID
- QI- Pediatric Vaccinations
- Status last verified
- May 2026
- First submitted
- 5 Mar 2021
- Last updated
- 14 May 2026
- 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 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Vaccinations
- ClinicalTrials.gov ID
- NCT04936776
- Acronym / sponsor ID
- QI- Pediatric Vaccinations
- Conditions
- Pediatric ALL, Vaccination, Immunization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,034 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 23 Jun 2021 (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.
As the Covid-19 pandemic hit New York City in the spring of 2020, many families were home-bound due to the city-wide lockdown. As a result, families in New York City were unable to attend their child's healthcare appointments and many young children did not receive their regularly-scheduled vaccinations. Parts of the city-wide lockdown did eventually lift in the summer of 2020 as positive Covid-19 virus rates declined in NYC. However, regularly scheduled vaccination rates (non-Covid-related) remain low. Yet, it is critical that young children receive their mandatory vaccines in a timely manner to decrease the chance of contracting preventable illnesses. Thus, the investigators seek to increase vaccination rates among children ages 0-2 years in Sunset Park Brooklyn.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Text message 1 | – | Behavioral: Text messagingText messaging frame = safety and cleanness of clinic site. Text parents of children 0-2 years old who are due and due soon for a vaccine across the entire NYU-Brooklyn Family Health Center network. |
| Text message 2 | – | Behavioral: Text messagingText messaging frame = importance of vaccines. Text parents of children 0-2 years old who are due and due soon for a vaccine across the entire NYU-Brooklyn Family Health Center network. |
| No text message | – | –No text sent. |
Who may qualify
- Ages
- 1 year to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children ages 0-2 years with delayed vaccinations (due for vaccine and due soon) in NYU Brooklyn Family Health Centers network.
Key inclusion criteria (1 listed)
- Children ages 0-2 years with delayed vaccinations (due for vaccine and due soon) in NYU Brooklyn Family Health Centers network.
Key exclusion criteria (1 listed)
- Children above the age of 2 who do not attend NYU Brooklyn Family Health Centers network
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 messagingText parents of children (age 0-2yrs) who are due and due soon for a vaccine across the entire NYU-Brooklyn FHC network to increase vaccination rates. | Behavioural | Text message 1, Text message 2 |
Primary outcome
Change in pediatric vaccination rate among children ages 0-2 years (proportion of vaccines due per person)
Time frame: Baseline - 1 year
1 secondary outcome
Number of scheduled appointments
Time frame: 1 year
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 14 May 2026.
- 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.
Holly Krelle principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric ALL and Vaccination, run by NYU Langone Health at 1 site 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 1 inclusion and 1 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in pediatric vaccination rate among children ages 0-2 years (proportion of vaccines due per person) (time frame: Baseline - 1 year). 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 14 May 2026.