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Safety and Immunogenicity of a Newly 23-valent Pneumococcal Polysaccharide Vaccine in Chinese Adults and Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285036
First Posted: November 6, 2014
Last Update Posted: November 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Guangxi Center for Disease Control and Prevention
Fourth Military Medical University
Information provided by (Responsible Party):
Walvax Biotechnology Co., Ltd.
  Purpose
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.

Condition Intervention Phase
Pneumococcal Infectious Diseases Biological: vaccination PPV23 Biological: vaccination PNEUMOVAX 23 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: A Phase III Clinical Trial for a Newly 23-valent Pneumococcal Polysaccharide Vaccine in Chinese Adults and Children

Resource links provided by NLM:


Further study details as provided by Walvax Biotechnology Co., Ltd.:

Primary Outcome Measures:
  • the rate of 2-fold increase of anti-pneumococcal antibody [ Time Frame: 30 days after the injection of vaccination ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1660
Study Start Date: September 2012
Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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. 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.-
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
China, Guangxi
Guangxi Provincial Center for Diseases Control and Prevention
Nanning, Guangxi, China
Sponsors and Collaborators
Walvax Biotechnology Co., Ltd.
Guangxi Center for Disease Control and Prevention
Fourth Military Medical University
Investigators
Principal Investigator: Yanping Li Guangxi Provincial Center for Diseases Control and Prevention
  More Information

Responsible Party: Walvax Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02285036     History of Changes
Other Study ID Numbers: Walvax-01
First Submitted: October 28, 2014
First Posted: November 6, 2014
Last Update Posted: November 6, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Communicable Diseases
Infection
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs