Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure

November 17, 2015 updated by: Patrick Javid, Seattle Children's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The safety of the rotavirus vaccine in infants with intestinal failure is the primary outcome variable.
Time Frame: 1-12 weeks following vaccine administration
1-12 weeks following vaccine administration

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1-12 weeks following vaccine administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Children's Hospital

Collaborators

National Center for Research Resources (NCRR)
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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

October 13, 2009

First Submitted That Met QC Criteria

October 14, 2009

First Posted (ESTIMATE)

October 15, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RS_Rota_vaccine_if

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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