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Completed

NCT Number: NCT00995813

Pilot Study 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.

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Key information

Conditions

Intestinal Failure Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rotavirus Vaccines

Age range

6 week–14 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rotarix

Biological

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.

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

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • National Center for Research Resources (NCRR)
  • Thrasher Research Fund

Registry information

Official study title

Pilot Study of the Safety and Immunogenicity of the Rotavirus Vaccine in Infants With Intestinal Failure

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Oct 15, 2009
Registry last updated
Nov 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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