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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
| National Center for Research Resources (NCRR) | NIH |
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The purpose of this study is to assess the safety and immune response of the rotavirus vaccine in infants who have undergone abdominal surgery.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotarix | Biological | A rotavirus vaccine (Rotarix) will be administered in two doses, 8 weeks apart, in infants between 6 and 14 weeks of age. The standard dosage is 1 mL administered orally or per gastrostomy tube. |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of the rotavirus vaccine in infants with intestinal failure is the primary outcome variable. | 1-12 weeks following vaccine administration |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary outcome measure is the preliminary measurement of the immunogenicity of the rotavirus vaccine in infants with intestinal failure. | 1-12 weeks following vaccine administration |
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Inclusion Criteria:
Infants with one of the following diagnoses:
Minimum gestational age of 35 weeks at time of first vaccine dose
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick J Javid, MD | Seattle Children's Hospital and The University of Washington | Principal Investigator |
| Simon Horslen, M.B., ChB | Seattle Children's Hospital and The University of Washington | Principal Investigator |
| Janet Englund, MD | Seattle Children's Hospital and The University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
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| ID | Term |
|---|---|
| D000090124 | Intestinal Failure |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C492457 | RIX4414 vaccine |
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