Study of Evaluation Indexes for Antibody Production in Sera After Immunization

August 24, 2009 updated by: Ewha Womans University

A 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 Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-125
        • Ewha Womans University Dongdaemun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Pneumo23®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University

Investigators

  • Principal Investigator: Kyung-Hyo Kim, Doctor, Ewha Womans University Dongdaemun Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (Estimate)

August 25, 2009

Study Record Updates

Last Update Posted (Estimate)

August 25, 2009

Last Update Submitted That Met QC Criteria

August 24, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EU-KF-05092341
  • 05092KFDA341

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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