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Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure

NCT00995813 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2015-11-18

No results posted yet for this study

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.

Conditions

  • Intestinal Failure
  • Rotavirus Vaccines

Interventions

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.

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Patrick J Javid, MD · Seattle Children's Hospital and The University of Washington

  • Simon Horslen, M.B., ChB · Seattle Children's Hospital and The University of Washington

  • Janet Englund, MD · Seattle Children's Hospital and The University of Washington

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Weeks
Max Age
14 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2012-05-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00995813 on ClinicalTrials.gov