NCT01512056

Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine,Formulation 2011-2012, in Dialysis Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	AdimFlu-S	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).

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2012-01-19
• Last updated: 2012-01-19

Locations

1 site across 1 country: Taiwan