NCT02105519

The Effect and Safety of the Seasonal Trivalent Influenza Vaccine in Chronic Kidney Disease Patients Not on Dialysis

The Immunogenicity and Safety of the Seasonal Influenza Vaccine, Formulation 2013-2014, in Chronic Kidney Disease Patients Not on Dialysis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In recent years, several studies revealed that the current influenza vaccine strategy might be of minimal vaccine effectiveness and had a smaller effect on reducing morbidity and mortality in the end-stage renal disease population than previously thought. Thus, this also raised the question about the effectiveness of administration of influenza vaccination in chronic kidney disease patients not on dialysis. In this study, the investigators aim to evaluate the effectiveness of seasonal trivalent influenza vaccine, formulation 2013-2014, in patients with different stage of chronic kidney disease (CKD) not on dialysis.

Detailed description

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by the method of hemagglutination inhibition (HI) and ELISA-based microneutralization (microNT-ELISA) assays. All participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 4). The investigators will collect serum of participants at the 5th weeks, 9th weeks, and 21th week post vaccination and evaluate the difference of immune response in these 3 groups.

Conditions

• Immunogenicity and Adverse Drug Effect of Vaccines Influenza
• Chronic Kidney Disease

Interventions

Type	Name	Description
BIOLOGICAL	Seasonal influenza vaccine (AdimFlu-S)	Participants receiving 0, 1 and 2 dose of AdimFlu-S during the study period.(a) No vaccination: no any influenza vaccination during the study period.(b) One dose of AdimFlu-S group: patient will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at the initiation of the study.(c)Two doses of AdimFlu-S group: patients will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at week 0 and 4 weeks after the initiation of the study.

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-04-07
• Last updated: 2014-04-07

Locations

1 site across 1 country: Taiwan