Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients
|ClinicalTrials.gov Identifier: NCT01512056|
Recruitment Status : Unknown
Verified January 2012 by National Cheng-Kung University Hospital.
Recruitment status was: Recruiting
First Posted : January 19, 2012
Last Update Posted : January 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Drug: AdimFlu-S||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||March 2012|
Experimental: the immunogenicity profiles of the AdimFlu-S
Experimental group: to receive either only one dose of influenza vaccine at day 0 or one more booster vaccination 3 weeks later.
Negative control group: dialysis patients who refused to receive influenza vaccination.
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). Each dose of vaccine contains 15μg antigen of each virus strain suggested by WHO (A/California/7/2009 (H1N1);A/Perth/16/2009 (H3N2);B/Brisbane/60/2008).
No Intervention: The safety outcome of the vaccine
Any adverse effect, including systemic or local site, will be recorded during the study period.
- Change of antibody titer before and after influenza vaccination [ Time Frame: 18 weeks ]The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HI titer ≥ 1:40. MicroNT-ELISA assay will also be used to evaluate the immune response post vaccination. The immune response based on microNT-ELISA antibody titers would be reported as antibody titer ≥1: 40 or ≥ 1:160 respectively because no threshold of protective NT antibody titer is clearly defined by the international guidelines.
- Seroresponse rate [ Time Frame: 0, 3 weeks, 6 weeks, 9 weeks and 18 weeks ]The seroconversion is defined as the HI titer of the post-vaccination serum is at least 1:40 for those who had a negative pre-vaccination HI serum titer or a four-fold or greater increase in HI titers in subjects who had a positive pre-vaccination HAI serum titer.
- Seroresponse rate [ Time Frame: 0, 3 weeks, 6 weeks, 9 weeks and 18 weeks ]
The seroresponse is defined as HI or micro-NT titer of the post-vaccination serum is at least 4-fold increase of the HI or micro-NT titer after vaccination.
Geometric mean folds increase in HI or micro-NT titer.
- the safety and tolerability profiles of the vaccine [ Time Frame: 0, 3 week, 6 weeks, 9 weeks, 18 weeks ]evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S manufactured by Adimmune Corporation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512056
|Contact: Junne Ming Sung, MD||886-6-2353535 ext firstname.lastname@example.org|
|Contact: Yu Tzu Chang, MD and Msc||886-6-2353535 ext email@example.com|
|National Cheng Kung University Hospital||Recruiting|
|Tainan, Taiwan, 704|
|Contact: Junne Ming Sung, MD 886-6-2353535 ext 2594 firstname.lastname@example.org|
|Contact: Yu Tzu Chang, MD and Msc 886-6-2353535 ext 2593 email@example.com|
|Principal Investigator: Junne Ming Sung, MD|
|Sub-Investigator: Yu Tzu Chang, MD and Msc|
|Sub-Investigator: Yi Ching Yang, MD|
|Sub-Investigator: Meng Te Lin, MD|