Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure
Information source: Seattle Children's Hospital
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intestinal Failure; Rotavirus Vaccines
Intervention: Rotarix (Biological)
Phase: Phase 4
Status: Recruiting
Sponsored by: Seattle Children's Hospital Official(s) and/or principal investigator(s):
Patrick J Javid, MD, Principal Investigator, Affiliation: Seattle Children's Hospital and The University of Washington
Simon Horslen, M.B., ChB, Principal Investigator, Affiliation: Seattle Children's Hospital and The University of Washington
Janet Englund, MD, Principal Investigator, Affiliation: Seattle Children's Hospital and The University of Washington
Overall contact:
Patrick J Javid, MD, Phone: 206-987-6129, Email: patrick.javid@seattlechildrens.org
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.
Clinical Details
Official title: Pilot Study of the Safety and Immunogenicity of the Rotavirus Vaccine in Infants With Intestinal Failure
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: The safety of the rotavirus vaccine in infants with intestinal failure is the primary outcome variable.
Secondary outcome: The secondary outcome measure is the preliminary measurement of the immunogenicity of the rotavirus vaccine in infants with intestinal failure.
Eligibility
Minimum age: 6 Weeks.
Maximum age: 14 Weeks.
Gender(s): Both.
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.
Locations and Contacts
Patrick J Javid, MD, Phone: 206-987-6129, Email: patrick.javid@seattlechildrens.org
Seattle Children's Hospital, Seattle, Washington 98105, United States; Recruiting
Patrick J Javid, MD, Phone: 206-987-6129, Email: patrick.javid@seattlechildrens.org
Additional Information
Starting date: December 2009
Last updated: July 21, 2011
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