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NCT02542462 · ClinicalTrials.gov registry record · Phase 4
Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study
A Phase 4 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 144
- Enrollment target
NCT02542462: Completed Phase 4 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT02542462 is a Phase 4 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 144 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02542462, a Phase 4 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 144 participants
- Enrollment target
Study Summary
This is a prospective randomized clinical trial that aims to evaluate the potential effects of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood and stool cytokine responses. It will also assess the association between these outcomes and the pattern of the shedding of vaccine strain rotavirus in the stool. Infants will be randomized to one of four arms: monovalent rotavirus vaccine (Rotarix®, RV1) alone, RV1 with other recommended vaccines, pentavalent rotavirus vaccine (RotaTeq®, RV5) alone, or RV5 with other recommended vaccines. Data derived from the pilot study will be used to assess the feasibility of conducting a larger scale study.
Primary Outcome
Number of subjects with an increase in the number of abdominal lymph nodes, as measured by abdominal ultrasound, or an increase of 1 mm or more of terminal ileum wall thickness, as measured by abdominal MRI, from Day 0 (Visit 1) to Day 4-6 (Visit 2)
Interventions
- DRUG Rotarix®,
- DRUG Rotarix®, with other routine vaccines
- DRUG RotaTeq®,
- DRUG RotaTeq®, with other routine vaccines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2015-11 |
| Est. Completion | 2017-05 |
| Phase | Phase 4 |
What the finished NCT02542462 record still lists
NCT02542462 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 4 interventions - of which Rotarix®, is the first listed.
NCT02542462 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02542462 about?
NCT02542462 is a clinical study titled "Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study". This is a prospective randomized clinical trial that aims to evaluate the potential effects of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood and stool cytokine responses. It will also assess the association between these outcomes and the pattern of the shedd...
What is the current status of trial NCT02542462?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 144 participants. The study started on 2015-11. Estimated completion is 2017-05.
What interventions are being tested in trial NCT02542462?
The interventions under investigation include: Rotarix®, (DRUG), Rotarix®, with other routine vaccines (DRUG), RotaTeq®, (DRUG), RotaTeq®, with other routine vaccines (DRUG).
Who is sponsoring clinical trial NCT02542462?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02542462's enrollment target sits among peer trials
144 577th of 2000 higher than 1,421 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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