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NCT05157191 · ClinicalTrials.gov registry record
Safety of Pediatric COVID-19 Vaccination
A clinical trial of Pain and Adverse Drug Event, sponsored by Duke University.
- Completed
- Registry status
- 299
- Enrollment target
- 5
- Study locations
NCT05157191 is a study of Pain and Adverse Drug Event that has completed, run by Duke University. The registered enrollment target is 299 participants, roughly in line with the 303-participant average among 374 other Pain trials with a reported enrollment target. The trial reports 5 study locations across 5 states.
The verdict
NCT05157191, a study of Pain and Adverse Drug Event, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 299 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a prospective, observational study. During the study, children and adolescents (ages ≥ 5 to \< 16) will be followed post administration of mRNA COVID-19 vaccines. Injection site (local), systemic reaction, and unsolicited adverse event data will be assessed on vaccination day and during the 7 days following each vaccination using either identical web-based or paper diaries, depending on study participant preference. At Duke University, Cincinnati's Children Hospital, and Kaiser Permanente Northern California, serum samples will be collected for optional assessment of antibody titers to COVID-19. Each participant who opts in will have baseline (within 3 days of vaccination) serologies obtained and immunogenicity assessment at 28 (+7) days after each dose. All participants will be followed for 180 days after dose 2 for serious adverse events and adverse events of special interest.
Conditions Studied
Interventions
- OTHER Observational
Study Locations (5)
California
- Kaiser Permanente Northern California - Oakland
Georgia
- Centers for Disease Control and Prevention - Atlanta
New York
- Columbia University - New York
North Carolina
- Duke University - Durham
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2022-04-06 |
| Est. Completion | 2023-10-27 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05157191
The ClinicalTrials.gov registry entry for NCT05157191 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 299 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 303-participant average among 374 other Pain trials with a reported enrollment target. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Pain appearing as the primary indexed condition, and to 1 intervention - of which Observational is the first listed.
NCT05157191 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT05157191 about?
NCT05157191 is a clinical study titled "Safety of Pediatric COVID-19 Vaccination". This is a prospective, observational study. During the study, children and adolescents (ages ≥ 5 to \< 16) will be followed post administration of mRNA COVID-19 vaccines. Injection site (local), systemic reaction, and unsolicited adverse event data will be assessed on vaccination day and during the...
What is the current status of trial NCT05157191?
This trial is currently completed. The enrollment target is 299 participants. The study started on 2022-04-06. Estimated completion is 2023-10-27.
What conditions does trial NCT05157191 study?
This clinical trial studies the following conditions: Pain, Adverse Drug Event, Injection Site Reaction.
What interventions are being tested in trial NCT05157191?
The interventions under investigation include: Observational (OTHER).
Who is sponsoring clinical trial NCT05157191?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05157191 being conducted?
This trial has 5 study locations across California, Georgia, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.