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Study of Evaluation Indexes for Antibody Production in Sera After Immunization

This study has been completed.
Sponsor:
Information provided by:
Ewha Womans University
ClinicalTrials.gov Identifier:
NCT00964769
First received: August 24, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Aged
 Biological: pneumococcal polysaccharide vaccine
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 70
Study Start Date: April 2005
Study Completion Date: June 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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).

  Eligibility

Ages Eligible for Study:   2 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964769

Locations
Korea, Republic of
Ewha Womans University Dongdaemun Hospital
Seoul, Korea, Republic of, 110-125
Sponsors and Collaborators
Ewha Womans University
Investigators
Principal Investigator: Kyung-Hyo Kim, Doctor Ewha Womans University Dongdaemun Hospital
  More Information

No publications provided

Responsible Party: Kyung-Hyo Kim, Ewha Womans Univrsity Hospital
ClinicalTrials.gov Identifier: NCT00964769     History of Changes
Other Study ID Numbers: EU-KF-05092341, 05092KFDA341
Study First Received: August 24, 2009
Last Updated: August 24, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ewha Womans University:
Pneumococcal Vaccine
Aged

Additional relevant MeSH terms:
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013