Study of Evaluation Indexes for Antibody Production in Sera After Immunization

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00964769

Enrollment

Registered

2009-08-25

Start date

2005-04-30

Completion date

2005-06-30

Last updated

2009-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aged

Keywords

Pneumococcal Vaccine, Aged

Brief 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.

Detailed 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).

Interventions

BIOLOGICALpneumococcal polysaccharide vaccine

single intramuscular injection of 0.5 ml Pneumo23® (Sanofi-Aventis, Lyon France)

Study design

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Evaluate the immune response to the pneumococcal polysaccharide vaccine in children, young adults and elderly.	1 month after vaccination

Secondary

Measure	Time frame
Evaluate the immune response to the pneumococcal polysaccharide vaccine with two methods (ELISA and Opsonophagocytic Killing Assay)	1 month after vaccination

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026