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Completed

NCT Number: NCT00964769

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.

Completed

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Key information

Conditions

Aged

Age range

2 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ewha Womans University Dongdaemun Hospital

Seoul, 110-125, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pneumococcal polysaccharide vaccine

Biological

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

Other names: Pneumo23®

Primary outcomes

  1. Evaluate the immune response to the pneumococcal polysaccharide vaccine in children, young adults and elderly.

    Time frame: 1 month after vaccination

Secondary outcomes

  1. Evaluate the immune response to the pneumococcal polysaccharide vaccine with two methods (ELISA and Opsonophagocytic Killing Assay)

    Time frame: 1 month after vaccination

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Aug 25, 2009
Registry last updated
Aug 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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