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

NCT02285036 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1660

Last updated 2014-11-06

No results posted yet for this study

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, PNEUMOVAX 23 (Merck \& Co., Inc.) controlled phase 3 clinical trial was conducted.

Conditions

  • Pneumococcal Infectious Diseases

Interventions

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.

BIOLOGICAL

vaccination PNEUMOVAX 23

Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1.

Sponsors & Collaborators

  • Guangxi Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Air Force Military Medical University, China

    collaborator OTHER

  • Walvax Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yanping Li · Guangxi Provincial Center for Diseases Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-12-31
Completion
2013-05-31

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 NCT02285036 on ClinicalTrials.gov