Influenza Clinical Trial
Official title:
Immunogenicity of a Trivalent Influenza Vaccine in Patients With Chronic Kidney Disease Undergoing Hemodialysis: MF59-adjuvanted Versus Non-adjuvanted Vaccines
| Verified date | February 2016 |
| Source | Korea University Guro Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Korea: Institutional Review Board |
| Study type | Interventional |
During the 2013-2014 influenza season, CKD patients undergoing HD participated in the study. The patients were randomized into two groups (MF59-adjuvanted vaccine group or non-adjuvanted vaccine group) and were immunized with the respective vaccine. Sera were collected prior to vaccination and at 1and 6 months post vaccination. Levels of hemagglutination inhibition (HI) antibodies were measured.
| Status | Completed |
| Enrollment | 174 |
| Est. completion date | November 2014 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 19 Years and older |
| Eligibility |
Inclusion Criteria: - Chronic kidney disease patients undergoing hemodialysis - Who have given written informed consent at the time of enrollment Exclusion Criteria: - Recipients of influenza vaccine of 2013-2014 season before the study - History of egg allergy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Korea University Guro Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Seroprotection rate (A/H1N1, A/H3N2, B) | the proportion of participants with a HI titer level of =1:40 | 1 month after vaccination | No |
| Primary | Seroconversion rate (A/H1N1, A/H3N2, B) | the percentage of subjects with either a pre-vaccination HI titer =1:10 and a =4-fold increase in 1 month after vaccination HI antibody titer from pre-vaccination or pre-vaccination HI titer <1:10 and a 1 month after vaccination HI titer of =1:40 | Change of titer from pre-vaccination to 1 month after vaccination | No |
| Primary | GMT fold change (A/H1N1, A/H3N2, B) | GMT ratio of the 1 month after vaccination titer to pre-vaccination titer | Change of GMT from pre-vaccination to 1 month after vaccination | No |
| Secondary | Seroprotection rate (A/H1N1, A/H3N2, B) | the proportion of participants with a HI titer level of =1:40 | 6 months after vaccination | No |
| Secondary | Seroconversion rate (A/H1N1, A/H3N2, B) | the percentage of subjects with either a pre-vaccination HI titer =1:10 and a =4-fold increase in 6 months after vaccination HI antibody titer from pre-vaccination or pre-vaccination HI titer <1:10 and a 6 months after vaccination HI titer of =1:40 | Change of titer from pre-vaccination to 6 months after vaccination | No |
| Secondary | GMT fold change (A/H1N1, A/H3N2, B) | GMT ratio of the 6 months after vaccination titer to pre-vaccination titer | Change of GMT from pre-vaccination to 6 months after vaccination | No |
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