Clinical trial NCT01512056: Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients
Official title: Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza vaccine
dialysis
vaccine
Seroprotection
Seroresponse
Seroconversion
Safety of the vaccine
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the antibody response in dialysis patents to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine (Formulation 2011-2012).

Detailed description: The immune response to influenza vaccine was poor in dialysis population than general population. The investigators want to evaluate another booster vaccination can improve the immune response in dialysis population. All enrolled 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 3). The investigators will collect serum of participants 3 weeks, 6 weeks, 9 weeks and 18 weeks post vaccination and evaluate the difference of immune response in these 3 groups.

Eligibility criteria: Inclusion Criteria:

1. Males and non-pregnant females and aged more than 18 years;
2. Willing and able to adhere to visit schedules and all study requirements;
3. Subjects read and signed the study-specific informed consent.

Exclusion Criteria:

1. Subject or his/her family is employed by the participated hospital;
2. Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;
3. History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
4. Personal or family history of Guillain-Barré Syndrome;
5. An acute febrile illness within 1 week prior to vaccination;
6. Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;
7. 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;
8. Female subjects who are pregnant during the study.
9. Patients who receive hemodialysis therapy less than 3 months.
10. Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
11. Immunodeficiency, or under immunosuppressive treatment.
12. 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);
13. Receipt of any blood products, including immunoglobulin in the prior 3 months;
14. Any severe illness needed to be hospitalization within three months.
15. Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.

Primary outcomes:
measure: Change of antibody titer before and after influenza vaccination
timeFrame: 18 weeks
Secondary outcomes:
measure: Seroresponse rate
timeFrame: 0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
measure: Seroresponse rate
timeFrame: 0, 3 weeks, 6 weeks, 9 weeks and 18 weeks
measure: the safety and tolerability profiles of the vaccine
timeFrame: 0, 3 week, 6 weeks, 9 weeks, 18 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References: