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CompletedNCT00995813Updated Nov 18, 2015

Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure

A Phase 4 interventional study of Rotarix in Intestinal Failure and Rotavirus Vaccines, sponsored by Seattle Children's Hospital. Completed at 1 site in United States. Open to participants aged 6 Weeks to 14 Weeks. Per ClinicalTrials.gov, last updated 2015-11-18.

Sponsored by Seattle Children's Hospital · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
6 Weeks to 14 Weeks
Sex
All
01

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.

02

Conditions studied

  • Intestinal Failure
  • Rotavirus Vaccines

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Keywords

  • Intestinal failure
  • Rotavirus vaccine
  • Infants
03

In context

Intestinal Failure

66 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.

This study's enrollment of 15 is below the median of 38 across 40 interventional studies indexed under Intestinal Failure.

Browse Intestinal Failure studies →

Lead sponsor

Seattle Children's Hospital is the lead sponsor of 210 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Weeks to 14 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Interventions

  • BiologicalRotarix

    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.

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

07

Study locations

1 site
  • Seattle Children's Hospital
    Seattle, Washington 98105, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00995813
Lead sponsor
Seattle Children's Hospital
Collaborators
Thrasher Research Fund, National Center for Research Resources (NCRR)
Responsible party
Patrick Javid (Principal Investigator, Seattle Children's Hospital) — Principal investigator
First posted
Oct 15, 2009
Start date
Dec 2009
Primary completion
May 2012
Completion
Jul 2013
Last update
Nov 18, 2015

Study contacts

Patrick J Javid, MD
principal investigator · Seattle Children's Hospital and The University of Washington
Simon Horslen, M.B., ChB
principal investigator · Seattle Children's Hospital and The University of Washington
Janet Englund, MD
principal investigator · Seattle Children's Hospital and The University of Washington

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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