The Effect and Safety of the Seasonal Trivalent Influenza Vaccine in Chronic Kidney Disease Patients Not on Dialysis
Immunogenicity and Adverse Drug Effect of Vaccines Influenza, Chronic Kidney Disease
About this trial
This is an interventional treatment trial for Immunogenicity and Adverse Drug Effect of Vaccines Influenza focused on measuring trivalent influenza vaccine, chronic kidney disease
Eligibility Criteria
Inclusion Criteria:
- .Males and non-pregnant females and aged ≥ 18 years with chronic kidney disease not on dialysis;
- .Willing and able to adhere to visit schedules and all study requirements;
- .Subjects read and signed the study-specific informed consent.
- .Subjects who has either received the first dose of 2013-2014 seasonal influenza vaccination before or not.
Exclusion Criteria:
- .Subject or his/her family is employed by the participated hospital;
- .History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
- .Personal or family history of Guillain-Barré Syndrome;
- .An acute febrile illness within 1 week prior to vaccination;
- .Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;
- .Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
- .Female subjects who are pregnant during the study.
- .Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
- .Immunodeficiency, or under immunosuppressive treatment.
- .Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);
- .Receipt of any blood products, including immunoglobulin in the prior 3 months;
- .Any severe illness needed to be hospitalization within three months.
- .Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.
Sites / Locations
- National Cheng Kung UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Experimental
The group receiving no influenza vaccine
One dose of AdimFlu-S group
Two dose of AdimFlu-S group
Participants in this group will not receive any influenza vaccine (negative control group).
Participants in this group will receive one dose of the seasonal trivalent influenza vaccine (one dose of AdimFlu-S group), formulation 2013-2014, at the initiation of the study. Each administered dose contain 15 ug virus antigen for each virus strain.
Participants in this group (Two dose of AdimFlu-S group)will receive the seasonal trivalent influenza vaccine, formulation 2013-2014, at the week 0 and 4 weeks after the initiation of the study. Each administered dose contain 15 ug virus antigen for each virus strain.