Intestinal Failure, Rotavirus Vaccines
Conditions
Keywords
Intestinal failure, Rotavirus vaccine, Infants
Brief summary
The purpose of this study is to assess the safety and immune response of the rotavirus vaccine in infants who have undergone abdominal surgery.
Interventions
BIOLOGICALRotarix
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.
Sponsors
Thrasher Research Fund
National Center for Research Resources (NCRR)
Seattle Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 14 Weeks
Healthy volunteers
No
Inclusion criteria
* Infants with one of the following diagnoses: * necrotizing enterocolitis requiring operation; * congenital atresia of the intestine; * gastroschisis; * midgut volvulus requiring bowel resection; or * long-segment intestinal aganglionosis * Minimum gestational age of 35 weeks at time of first vaccine dose
Exclusion criteria
* immunocompromise secondary to HIV infection or immunodeficiency state * active use of corticosteroid or other immunosuppressive agents * active infection as defined by fever \> 38°C within 24 hours, positive blood culture within 7 days, or positive urine culture within 3 days of enrollment * severe malnutrition as defined by serum albumin \< 2.0 mg/dL or serum prealbumin \< 6 mg/dL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety of the rotavirus vaccine in infants with intestinal failure is the primary outcome variable. | 1-12 weeks following vaccine administration |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed