Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure

Intestinal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995813
• Other study ID #: RS_Rota_vaccine_if
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2009
• Last updated: November 17, 2015
• Start date: December 2009
• Est. completion date: July 2013

Study information

• Verified date: November 2015
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Weeks to 14 Weeks

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intestinal Failure
• Rotavirus Vaccines

Intervention

Biological:
• Rotarix
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.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Seattle Children's Hospital	National Center for Research Resources (NCRR), Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety of the rotavirus vaccine in infants with intestinal failure is the primary outcome variable.		1-12 weeks following vaccine administration	Yes
Secondary	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	No