Safety and Immunogenicity of a Newly 23-valent Pneumococcal Polysaccharide Vaccine in Chinese Adults and Children
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|ClinicalTrials.gov Identifier: NCT02285036|
Recruitment Status : Completed
First Posted : November 6, 2014
Last Update Posted : November 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pneumococcal Infectious Diseases||Biological: vaccination PPV23 Biological: vaccination PNEUMOVAX 23||Phase 3|
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. Pneumococcal polysaccharide vaccines have progressed from 2-valent vaccines to the current 23-valent vaccine, which has been available since the early 1980s. The 23-valent vaccine includes serotypes accounting for 72% to 95% of invasive pneumococcal disease, depending on the geographic area. Many countries have added pneumococcal polysaccharide vaccine to their existing national immunization programs or recommended it for people aged 65 years and older and for individuals aged 2-64 who are at increased risk of pneumococcal disease.
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, PNEUMOVAX 23 (Merck & Co., Inc.) controlled phase 3 clinical trial was conducted.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1660 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||A Phase III Clinical Trial for a Newly 23-valent Pneumococcal Polysaccharide Vaccine in Chinese Adults and Children|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||May 2013|
Experimental: A newly PPV23
The treatment pneumococcal vaccine was developed by Yunnan Walvax Biotech Co., Ltd (Walvax) China, is a sterile, liquid vaccine for intramuscular or subcutaneous injection. It consists of a mixture of highly purified capsular polysaccharides from the 23 most prevalent or invasive pneumococcal types of Streptococcus pneumoniae, including the six serotypes that most frequently cause invasive drug-resistant pneumococcal infections among children and adults in China. The dose of vaccine is an individual with a 0.5ml dose contains 23 kinds of pneumococcal polysaccharide serotypes each 25μg, and does not contain any preservatives. Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1.
Biological: vaccination PPV23
All eligible participants were stratified into four age strata namely, 2 to 6 years, 7 to 17 years, 18 to 59 years and more than 60 years. Stratified, block randomization with a size of eight was applied. Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1. Blood samples were obtained from each subject at baseline, day 30-35 after injection, to evaluate immunogenicity.
Active Comparator: PNEUMOVAX 23
PNEUMOVAX 23 is an established US-licensed vaccine and manufactured by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1.
Biological: vaccination PNEUMOVAX 23
Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1.
- the rate of 2-fold increase of anti-pneumococcal antibody [ Time Frame: 30 days after the injection of vaccination ]
- geometric mean concentration (GMC) [ Time Frame: 30 days after the injection of vaccination ]
- geometric mean fold increase (GMFI) [ Time Frame: 30 days after the injection of vaccination ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285036
|Guangxi Provincial Center for Diseases Control and Prevention|
|Nanning, Guangxi, China|
|Principal Investigator:||Yanping Li||Guangxi Provincial Center for Diseases Control and Prevention|