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NCT00964769 Clinical Trial

Study of Evaluation Indexes for Antibody Production in Sera After Immunization

Aged Clinical Trial

Official title:
A Study of Evaluation Indexes for Antibody Production in Sera After Immunization

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00964769
Other study ID # EU-KF-05092341
Secondary ID 05092KFDA341
Status Completed
Phase Phase 4
First received August 24, 2009
Last updated August 24, 2009
Start date April 2005
Est. completion date June 2005

Study information
Verified date August 2009
Source Ewha Womans University
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date June 2005
Est. primary completion date May 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years to 90 Years
Eligibility Inclusion Criteria:

- elderly subjects over the age 65 years who had not received pneumococcal vaccination

- adult subjects under the age of 45 years (healthy volunteers with no previous history of pneumococcal vaccination)

- children subjects over the age of 2 years with no previous history of pneumococcal vaccination

Exclusion Criteria:

- immunocompromised, asplenia, cancer, liver or renal failure, and history of hypersensitivity to vaccine

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Biological:
• pneumococcal polysaccharide vaccine
single intramuscular injection of 0.5 ml Pneumo23® (Sanofi-Aventis, Lyon France)

Locations
Country Name City State
Korea, Republic of Ewha Womans University Dongdaemun Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Ewha Womans University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the immune response to the pneumococcal polysaccharide vaccine in children, young adults and elderly. 1 month after vaccination No
Secondary Evaluate the immune response to the pneumococcal polysaccharide vaccine with two methods (ELISA and Opsonophagocytic Killing Assay) 1 month after vaccination No
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