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ID
Source
Brief title
Condition
- Gastrointestinal infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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Secondary outcome
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Background summary
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Study objective
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Study design
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Intervention
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Study burden and risks
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Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- Creatinin clearance >= 40 ml/min
- Stable renal function for 1 year prior to inclusion
- Stabe immunosuppressive medication for 3 months prior to inclusion, consisting of prednisone in combination with either a calcineurine inhibitor, mycophenolate mofetil or an mTOR inhibitor
Exclusion criteria
- A chronic disease which may influence the immune system, other than the renal transplant and accompanying immunosupressive medication
- Chronic infection
- Treatment for graft rejection in the year prior to inclusion
- Prior vaccination with Dukoral or another oral cholera or ETEC vaccine.
- Prior Vibrio cholerae infection
- Travellers' diarrhea 6 months prior to inclusion
- Known allergy to the vaccine or to one of the vaccine components
- History of an anaphylactic reaction following vaccination
- Treatment with plasma or blood products in the 3 months prior to inclusion
- Pregnancy or breast feeding
- Immunosuppressive medication other than prednisone, a calcineurine inhibitor, mycophenolate mofetil or an mTOR inhibitor
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-018377-38-NL |
| CCMO | NL28010.058.10 |