Status:
COMPLETED
Safety and Immunogenicity of a Newly 23-valent Pneumococcal Polysaccharide Vaccine in Chinese Adults and Children
Lead Sponsor:
Walvax Biotechnology Co., Ltd.
Collaborating Sponsors:
Guangxi Center for Disease Control and Prevention
Air Force Military Medical University, China
Conditions:
Pneumococcal Infectious Diseases
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
A newly 23-valent pneumococcal polysaccharide vaccine was developed with promising safety and immunogenicity demonstrated in the phase III trial in China. A large scale, double blind, randomized, PNEU...
Detailed Description
The World Health Organization (WHO) estimated that more than 800 000 children younger than 5 years died from pneumococcal disease in 2000, making it the leading vaccine-preventable cause of death. Pne...
Eligibility Criteria
Inclusion
- Healthy participants older than 2 years were recruited and enrolled in September or October 2012.
- Participants with axillary temperature less than Celsius 37 degrees
- Not yet having received pneumococcal vaccine and other prevention products within 7 days.
Exclusion
- Exclusion criteria were any known primary or secondary immunodeficiency
- Allergy
- Severe cardiovascular disease bleeding disorders
- Receipt of immunoglobulin or blood products within one month and so on.-
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
1660 Patients enrolled
Trial Details
Trial ID
NCT02285036
Start Date
September 1 2012
End Date
May 1 2013
Last Update
November 6 2014
Active Locations (1)
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1
Guangxi Provincial Center for Diseases Control and Prevention
Nanning, Guangxi, China