Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure

Completed · Phase 4

Conditions studied: Intestinal Failure, Rotavirus Vaccines

In brief

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

Key facts

Study ID

NCT00995813

Run by

Seattle Children's Hospital

People needed

15

Starts

2009-12-01

Expected to finish

2013-07-01

Last updated by the study team

2015-11-18

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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