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Study of Evaluation Indexes for Antibody Production in Sera After Immunization

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ClinicalTrials.gov Identifier: NCT00964769
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : August 25, 2009
Sponsor:
Information provided by:
Ewha Womans University

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.

Condition or disease Intervention/treatment Phase
Aged Biological: pneumococcal polysaccharide vaccine Phase 4

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  (Clinical Trial)
Actual Enrollment : 70 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: A Study of Evaluation Indexes for Antibody Production in Sera After Immunization
Study Start Date : April 2005
Primary Completion Date : May 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Pneumo23®



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyung-Hyo Kim, Ewha Womans Univrsity Hospital
ClinicalTrials.gov Identifier: NCT00964769     History of Changes
Other Study ID Numbers: EU-KF-05092341
05092KFDA341
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009

Keywords provided by Ewha Womans University:
Pneumococcal Vaccine
Aged

Additional relevant MeSH terms:
Vaccines
Antibodies
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs