Immunogenicity of a Trivalent Influenza Vaccine in Chronic Kidney Disease Patients Undergoing Hemodialysis

Immunogenicity of a Trivalent Influenza Vaccine in Patients With Chronic Kidney Disease Undergoing Hemodialysis: MF59-adjuvanted Versus Non-adjuvanted Vaccines

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02686398

Enrollment

174

Registered

2016-02-19

Start date

2013-10-31

Completion date

2014-11-30

Last updated

2016-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, End Stage Renal Failure, Chronic Kidney Disease

Keywords

Influenza Vaccines, MF59 oil emulsion, End Stage Renal Failure on Dialysis

Brief 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.

Interventions

BIOLOGICALFluad

BIOLOGICALAgrippal

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Seroprotection rate (A/H1N1, A/H3N2, B)	1 month after vaccination	the proportion of participants with a HI titer level of ≥1:40
Seroconversion rate (A/H1N1, A/H3N2, B)	Change of titer from pre-vaccination to 1 month after vaccination	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
GMT fold change (A/H1N1, A/H3N2, B)	Change of GMT from pre-vaccination to 1 month after vaccination	GMT ratio of the 1 month after vaccination titer to pre-vaccination titer

Secondary

Measure	Time frame	Description
Seroprotection rate (A/H1N1, A/H3N2, B)	6 months after vaccination	the proportion of participants with a HI titer level of ≥1:40
Seroconversion rate (A/H1N1, A/H3N2, B)	Change of titer from pre-vaccination to 6 months after vaccination	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
GMT fold change (A/H1N1, A/H3N2, B)	Change of GMT from pre-vaccination to 6 months after vaccination	GMT ratio of the 6 months after vaccination titer to pre-vaccination titer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026