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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
  Purpose

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


Condition Intervention Phase
Intestinal Failure
Rotavirus Vaccines
Biological: Rotarix
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Study of the Safety and Immunogenicity of the Rotavirus Vaccine in Infants With Intestinal Failure

Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: December 2009
Study Completion Date: July 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   6 Weeks to 14 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995813

Locations
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Thrasher Research Fund
Investigators
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
  More Information

No publications provided

Responsible Party: Patrick Javid, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT00995813     History of Changes
Other Study ID Numbers: RS_Rota_vaccine_if
Study First Received: October 13, 2009
Last Updated: November 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:
Intestinal failure
Rotavirus vaccine
Infants

ClinicalTrials.gov processed this record on November 27, 2014