- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04936776
Pediatric Vaccinations
May 12, 2026 updated by: NYU Langone Health
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1034
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
-
-
New York
-
New York, New York, United States, 10016
- NYU Langone Health
-
-
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
1 year to 2 years (Child)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Children ages 0-2 years with delayed vaccinations (due for vaccine and due soon) in NYU Brooklyn Family Health Centers network.
Description
Inclusion Criteria:
- Children ages 0-2 years with delayed vaccinations (due for vaccine and due soon) in NYU Brooklyn Family Health Centers network.
Exclusion Criteria:
- Children above the age of 2 who do not attend NYU Brooklyn Family Health Centers network
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
|
No text message
No text sent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in pediatric vaccination rate among children ages 0-2 years (proportion of vaccines due per person)
Time Frame: Baseline - 1 year
|
Baseline - 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of scheduled appointments
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Holly Krelle, NYU Langone Health
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)
February 9, 2021
Primary Completion (Actual)
December 21, 2023
Study Completion (Actual)
January 2, 2024
Study Registration Dates
First Submitted
March 5, 2021
First Submitted That Met QC Criteria
June 22, 2021
First Posted (Actual)
June 23, 2021
Study Record Updates
Last Update Posted (Actual)
May 14, 2026
Last Update Submitted That Met QC Criteria
May 12, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QI- Pediatric Vaccinations
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
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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