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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 is a Phase 4 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 144 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02542462
The ClinicalTrials.gov registry entry for NCT02542462 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Rotarix®, is the first listed.
NCT02542462 reports 0 study locations.
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.
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