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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluad | Active Comparator | 88 CKD patients were vaccinated with Fluad. |
|
| Agrippal | Active Comparator | 86 CKD patients were vaccinated with Agrippal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluad | Biological |
| ||
| Agrippal |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection rate (A/H1N1, A/H3N2, B) | the proportion of participants with a HI titer level of ≥1:40 | 1 month after vaccination |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection rate (A/H1N1, A/H3N2, B) | the proportion of participants with a HI titer level of ≥1:40 | 6 months after vaccination |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hee Jin Cheong, MD, PhD | Korea University Guro Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C478243 | fluad vaccine |
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|
| Change of titer from pre-vaccination to 6 months after vaccination |
| 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 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |