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Safety and Immunogenicity of 23-valent Pneumococcal Polysaccharide Vaccine in 2 to 70 Years Old Healthy People in China

NCT01451086 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2013-03-15

No results posted yet for this study

Summary

Pneumococcal infection is a leading cause of death throughout the world and a major cause of pneumonia, bacteremia, meningitis, and otitis media.

It has been established that purified pneumococcal capsular polysaccharides induce antibody production and such antibody is effective in preventing pneumococcal disease. Clinical studies have demonstrated the immunogenicity of each of the 23 capsular types when tested in polyvalent vaccines. Studies of 23-valent pneumococcal vaccine in children of two years old and older and in adults of all ages have showed immunogenic response. In order to provide more evidence for the immunogenicity and the safety of the vaccine, a phase III clinical trial is planed to conduct.

Conditions

  • Healthy

Interventions

BIOLOGICAL

vaccine made by Beijing Minhai Biotechnology Co., Ltd

Subjects receive 0.5 mL/dose of 23-valent pneumococcal polysaccharide vaccine by intramuscular (deltoid) injection on Day 0.

BIOLOGICAL

vaccine made by Chengdu Institute of Biological Products

Subjects receive 0.5 mL/dose of 23-valent pneumococcal polysaccharide vaccine by intramuscular (deltoid) injection on Day 0.

Sponsors & Collaborators

  • Beijing Minhai Biotechnology Co., Ltd

    collaborator INDUSTRY

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-07-31
Completion
2012-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01451086 on ClinicalTrials.gov