drugset / Trial / NCT01451086
Safety and Immunogenicity of 23-valent Pneumococcal Polysaccharide Vaccine in 2 to 70 Years Old Healthy People in China
Phase 3
Completed
1200 enrolled
Jiangsu Province Centers for Disease Control and Prevention
Beijing Minhai Biotechnology Co., Ltd · collab
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2011-10
- Primary completion
- 2012-07
- Completion
- 2012-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pneumovax 23 | Vaccine | 0.5 ml | Intramuscular |
Indications
No indication recorded.