Intestinal FailurePhase 4NCT00995813
Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure
A Phase 4 study testing Rotarix in people with Intestinal Failure and Rotavirus Vaccines, run by Seattle Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 weeks
- Conditions the study is for
- Intestinal Failure, Rotavirus Vaccines
- What is being tested?
- Rotarix
- Type of treatment
- Vaccines, Pill or oral medicine
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jul 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: 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.
- Conditions
- Intestinal Failure, Rotavirus Vaccines
- Being tested
- Rotarix
- Keywords
- Intestinal failure, Rotavirus vaccine, Infants
- Medical subject headings
- Intestinal Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RotarixBiological
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of the rotavirus vaccine in infants with intestinal failure is the primary outcome variable.
Measured: 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.
Measured: 1-12 weeks following vaccine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal FailureStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund, National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, Patrick Javid, Seattle Children's Hospital
- Investigators
- Patrick J Javid, MD, Principal investigator, Seattle Children's Hospital and The University of WashingtonSimon Horslen, M.B., ChB, Principal investigator, Seattle Children's Hospital and The University of WashingtonJanet Englund, MD, Principal investigator, Seattle Children's Hospital and The University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995813
- Sponsor's protocol ID
- RS_Rota_vaccine_if
- Status last verified
- Nov 2015
- First submitted
- 13 Oct 2009
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Safety and Immunogenicity of the Rotavirus Vaccine in Infants With Intestinal Failure
- ClinicalTrials.gov ID
- NCT00995813
- Acronym / sponsor ID
- RS_Rota_vaccine_if
- Conditions
- Intestinal Failure, Rotavirus Vaccines
- Keywords
- Intestinal failure, Rotavirus vaccine, Infants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Thrasher Research Fund, National Center for Research Resources (NCRR)
- Study start
- Dec 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 14 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infants with one of the following diagnoses:
- Minimum gestational age of 35 weeks at time of first vaccine dose
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RotarixA 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. | Biological | – |
Primary outcome
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 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rotarix in people with Intestinal Failure and Rotavirus Vaccines, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of the rotavirus vaccine in infants with intestinal failure is the primary outcome variable. (time frame: 1-12 weeks following vaccine administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.