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Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure

This study has been completed.
Sponsor:
Collaborators:
Thrasher Research Fund
Information provided by (Responsible Party):
Patrick Javid, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT00995813
First received: October 13, 2009
Last updated: November 25, 2014
Last verified: November 2014

October 13, 2009
November 25, 2014
December 2009
May 2012   (final data collection date for primary outcome measure)
The safety of the rotavirus vaccine in infants with intestinal failure is the primary outcome variable. [ Time Frame: 1-12 weeks following vaccine administration ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00995813 on ClinicalTrials.gov Archive Site
The secondary outcome measure is the preliminary measurement of the immunogenicity of the rotavirus vaccine in infants with intestinal failure. [ Time Frame: 1-12 weeks following vaccine administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure
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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Intestinal Failure
  • Rotavirus Vaccines
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2013
May 2012   (final data collection date for primary outcome measure)

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.
Both
6 Weeks to 14 Weeks
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00995813
RS_Rota_vaccine_if
No
Patrick Javid, Seattle Children's Hospital
Seattle Children's Hospital
  • Thrasher Research Fund
  • National Center for Research Resources (NCRR)
Principal Investigator: 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
Seattle Children's Hospital
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP