Title

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

    Phase 4
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Indication/Condition

    Aged
  • Study Participants

    70
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.
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 Started
Apr 30
2005
Primary Completion
May 31
2005
Study Completion
Jun 30
2005
Last Update
Aug 25
2009
Estimate

Biological pneumococcal polysaccharide vaccine

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

  • Other names: Pneumo23®

Pneumococcal polysaccharide vaccine Experimental

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

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
No Results Posted