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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: Completed study of Pain and Adverse Drug Event, sponsored by Duke University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe
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 |
What the finished NCT05157191 record still lists
NCT05157191 is an observational study that tracks outcomes without assigning an intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 303-participant average among 374 other Pain trials with a reported enrollment target.
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 lists 5 locations in 5 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05157191's enrollment target sits among peer trials
299 61st of 374 higher than 312 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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