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OpenTrials
Completed

NCT Number: NCT02686398

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

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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Key information

Conditions

Influenza Chronic Disease Chronic Kidney Disease Disease Attributes End Stage Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Influenza, Human Kidney Diseases Male Urogenital Diseases Orthomyxoviridae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Urologic Diseases Virus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluad

Biological

Agrippal

Biological

Primary outcomes

  1. Seroprotection rate (A/H1N1, A/H3N2, B)

    Time frame: 1 month after vaccination

    the proportion of participants with a HI titer level of ≥1:40

  2. Seroconversion rate (A/H1N1, A/H3N2, B)

    Time frame: 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

  3. GMT fold change (A/H1N1, A/H3N2, B)

    Time frame: 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 outcomes

  1. Seroprotection rate (A/H1N1, A/H3N2, B)

    Time frame: 6 months after vaccination

    the proportion of participants with a HI titer level of ≥1:40

  2. Seroconversion rate (A/H1N1, A/H3N2, B)

    Time frame: 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

  3. GMT fold change (A/H1N1, A/H3N2, B)

    Time frame: Change of GMT from pre-vaccination to 6 months after vaccination

    GMT ratio of the 6 months after vaccination titer to pre-vaccination titer

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 19, 2016
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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