Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure



Status:Completed
Conditions:Vaccines
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:December 2009
End Date:July 2013

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Pilot Study of the Safety and Immunogenicity of the Rotavirus Vaccine in Infants With Intestinal Failure

The purpose of this study is to assess the safety and immune response of the rotavirus
vaccine in infants who have undergone abdominal surgery.


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.
We found this trial at
1
site
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
?
mi
from
Seattle, WA
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