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Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00995813
First Posted: October 15, 2009
Last Update Posted: November 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Thrasher Research Fund
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Patrick Javid, Seattle Children's Hospital
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Study of the Safety and Immunogenicity of the Rotavirus Vaccine in Infants With Intestinal Failure

Resource links provided by NLM:


Further study details as provided by Patrick Javid, 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 ]

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 ]

Enrollment: 15
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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 14 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995813


Locations
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Thrasher Research Fund
National Center for Research Resources (NCRR)
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

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
First Submitted: October 13, 2009
First Posted: October 15, 2009
Last Update Posted: November 18, 2015
Last Verified: November 2015

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

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs