Adjuvanted Influenza Vaccine Evaluation in Kidney Transplant Recipients
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| First Received Date ICMJE | April 23, 2012 | ||||||||
| Last Updated Date | April 24, 2012 | ||||||||
| Start Date ICMJE | August 2012 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01584908 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Adjuvanted Influenza Vaccine Evaluation in Kidney Transplant Recipients | ||||||||
| Official Title ICMJE | Adjuvanted Influenza Vaccine Evaluation in Kidney Transplant Recipients(AdVEnTR) | ||||||||
| Brief Summary | Influenza is an important public health problem. Organ transplant patients are particularly susceptible to severe disease. Also, they shed higher quantities of virus for longer durations, leading to greater contagious potential, thereby potentially serving as nodes of spread in the community. Therefore, improved strategies to prevent influenza in this population is an important public health concern. Standard vaccination is poorly immunogenic post-transplant and new vaccine strategies are needed. Adjuvanted vaccines contain molecules that create a strong local inflammatory response and they attract immune cells to the site of injection, increasing the immunogenicity of the vaccine antigen. Recently seasonal influenza vaccines containing adjuvants have become available in Canada but have only limited information in transplant patients. This randomized trial is designed to assess the immunogenicity of an adjuvanted vaccination strategy compared to a standard vaccine for seasonal influenza in a cohort of adult organ transplant recipients. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | adult kidney tranplant recipients |
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| Condition ICMJE | Influenza | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 440 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Adult kidney transplant recipients Greater than 3 months post-transplant Exclusion Criteria: Has already received influenza vaccination for 2012-2013 season Egg allergy Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome) Ongoing therapy for rejection Febrile illness in the past two weeks Unable to provide informed consent Unable to comply with study protocol |
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01584908 | ||||||||
| Other Study ID Numbers ICMJE | UofA - AdVEnTR | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | University of Alberta | ||||||||
| Study Sponsor ICMJE | University of Alberta | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | University of Alberta | ||||||||
| Verification Date | April 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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