Study of Evaluation Indexes for Antibody Production in Sera After Immunization

NCT00964769 | Completed Phase 4 DMC

• 2 other identifiers: EU-KF-0509234105092KFDA341
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Aged

Keywords

Pneumococcal Vaccine; Aged

Outcome Measures

Primary Outcomes (1)

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

  1 month after vaccination

Secondary Outcomes (1)

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

  1 month after vaccination

Study Arms (1)

Pneumococcal polysaccharide vaccine

EXPERIMENTAL

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

Biological: pneumococcal polysaccharide vaccine

Interventions

pneumococcal polysaccharide vaccine BIOLOGICAL

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

Also known as: Pneumo23®

Pneumococcal polysaccharide vaccine

Eligibility Criteria

• Age: 2 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• immunocompromised, asplenia, cancer, liver or renal failure, and history of hypersensitivity to vaccine

Sponsors & Collaborators

• Ewha Womans University: lead

Study Sites (1)

Ewha Womans University Dongdaemun Hospital

Seoul, Seoul, 110-125, South Korea

Location

Related Publications (1)

• Lee H, Nahm MH, Kim KH. The effect of age on the response to the pneumococcal polysaccharide vaccine. BMC Infect Dis. 2010 Mar 10;10:60. doi: 10.1186/1471-2334-10-60.

  PMID: 20219110 DERIVED

MeSH Terms

Interventions

Pneumococcal Vaccines; 23-valent pneumococcal capsular polysaccharide vaccine

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Kyung-Hyo Kim, Doctor

  Ewha Womans University Dongdaemun Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 25, 2009
• Study Start: April 1, 2005
• Primary Completion: May 1, 2005
• Study Completion: June 1, 2005
• Last Updated: August 25, 2009

Record last verified: 2009-08

Locations

KR (1)