Study of Evaluation Indexes for Antibody Production in Sera After Immunization
The aim of this study is to evaluate analytical methods such as ELISA and OPKA that measure the activity of vaccine-induced pneumococcal antibodies. After validation of ELISA and OPKA, pneumococcal antibodies were measured by ELISA and OPKA in paired samples before and after immunization (pneumococcal PS vaccine) in children, adults and elderly.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||A Study of Evaluation Indexes for Antibody Production in Sera After Immunization|
- Evaluate the immune response to the pneumococcal polysaccharide vaccine in children, young adults and elderly. [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]
- Evaluate the immune response to the pneumococcal polysaccharide vaccine with two methods (ELISA and Opsonophagocytic Killing Assay) [ Time Frame: 1 month after vaccination ] [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Study Completion Date:||June 2005|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
Experimental: Pneumococcal polysaccharide vaccine
The immunogenic response to the pneumococcal polysaccharide vaccine was compared between children, adults and elderly.
Biological: pneumococcal polysaccharide vaccine
single intramuscular injection of 0.5 ml Pneumo23® (Sanofi-Aventis, Lyon France)
Other Name: Pneumo23®
To evaluate the immune response to the pneumococcal polysaccharide vaccine in the elderly, samples from children, young adults and elderly were obtained before and one month after vaccination. The quantitative and qualitative response to the vaccine were measured by the ELISA and opsonophagocytic killing assay for eight vaccine type serotypes (4, 6B, 9V, 14, 18C, 19A, 19F, 23F) and one vaccine-related serotype (6A).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964769
|Korea, Republic of|
|Ewha Womans University Dongdaemun Hospital|
|Seoul, Korea, Republic of, 110-125|
|Principal Investigator:||Kyung-Hyo Kim, Doctor||Ewha Womans University Dongdaemun Hospital|