Study of Evaluation Indexes for Antibody Production in Sera After Immunization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2005-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Aged

Study Design

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Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Pneumococcal polysaccharide vaccine

The immunogenic response to the pneumococcal polysaccharide vaccine was compared between children, adults and elderly.

Group Type EXPERIMENTAL

pneumococcal polysaccharide vaccine

Intervention Type BIOLOGICAL

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

Interventions

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pneumococcal polysaccharide vaccine

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Pneumo23®

Eligibility Criteria

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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