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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02686398
Other study ID # KUGH13170
Secondary ID
Status Completed
Phase Phase 4
First received January 25, 2016
Last updated February 15, 2016
Start date October 2013
Est. completion date November 2014

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Biological:
Fluad

Agrippal


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Korea University Guro Hospital

Outcome

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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