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NCT00767364 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome
A Phase 1 study, sponsored by Children's Hospital of Michigan.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT00767364 is a Phase 1 study that has completed, run by Children's Hospital of Michigan. The registered enrollment target is 8 participants.
The verdict
NCT00767364, a Phase 1 study, has completed, sponsored by Children's Hospital of Michigan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Rotavirus infection is a common pediatric illness and is the leading cause of severe acute gastroenteritis (vomiting and diarrhea) in infants and young children. Since February of 2006, an oral vaccine to prevent rotavirus has been approved by the Food and Drug Administration (FDA). The company that makes the oral vaccine is Merck and Company. Since the FDA approval, the American Academy of Pediatrics (AAP) and that Advisory Committee on Immunization Practices (ACIP) has recommended the use of this oral vaccine in infants. A previous rotavirus oral vaccine, Rotashield, was removed from the market for concerns that it was causing an increase in a gastrointestinal (GI) disease called intussusception. However, the new rotavirus vaccine was studied by the manufacturer and was not found to cause an increase in the cases of intussusception. Intussusception is a disease in which a portion of the GI tract folds back on itself leading to GI tract obstruction or back-up. The manufacturer of the vaccine noted on package insert information that the vaccine was not studied, originally, in infants with a history of GI disorders or in infants who have had surgery on their abdomen. Currently, there is no information available in the scientific literature about the use of the oral rotavirus vaccine in infants with GI diseases or those who have had GI surgeries. The objective of the study is the assessment of safety and tolerability of the oral RotaTeq® vaccine for all infants participating in the study. All infants will be followed for clinical adverse events with active safety surveillance for the first 42 days after each dose and also monthly afterward for a total of 12 months from the first vaccination date. The secondary objective of the study is to quantify the immunologic response will occur in all of the infants in the study. Assessment of percentage of the number of infants who have a good immune response (three-fold rise in IgA titer or greater) to the complete rotavirus
Interventions
- BIOLOGICAL Oral, live, pentavalent rotavirus vaccine; RotaTeq(R)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2009-07 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00767364
The ClinicalTrials.gov registry entry for NCT00767364 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital of Michigan, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oral, live, pentavalent rotavirus vaccine; RotaTeq(R) is the first listed.
NCT00767364 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00767364 about?
NCT00767364 is a clinical study titled "Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome". Rotavirus infection is a common pediatric illness and is the leading cause of severe acute gastroenteritis (vomiting and diarrhea) in infants and young children. Since February of 2006, an oral vaccine to prevent rotavirus has been approved by the Food and Drug Administration (FDA). The company that...
What is the current status of trial NCT00767364?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2009-07. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00767364?
The interventions under investigation include: Oral, live, pentavalent rotavirus vaccine; RotaTeq(R) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00767364?
This trial is sponsored by Children's Hospital of Michigan, which has 5 total clinical trials registered on ClinicalTrials.gov.
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