Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|