Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure
Pilot Study of the Safety and Immunogenicity of the Rotavirus Vaccine in Infants With Intestinal Failure
1 other identifier
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2009
CompletedFirst Posted
Study publicly available on registry
October 15, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedNovember 18, 2015
November 1, 2015
2.4 years
October 13, 2009
November 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The safety of the rotavirus vaccine in infants with intestinal failure is the primary outcome variable.
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.
1-12 weeks following vaccine administration
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seattle Children's Hospitallead
- Thrasher Research Fundcollaborator
- National Center for Research Resources (NCRR)collaborator
Study Sites (1)
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 13, 2009
First Posted
October 15, 2009
Study Start
December 1, 2009
Primary Completion
May 1, 2012
Study Completion
July 1, 2013
Last Updated
November 18, 2015
Record last verified: 2015-11