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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,660

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

December 31, 2012

Study Completion Date

May 31, 2013

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.

Trial Locations (1)

Unknown

Guangxi Provincial Center for Diseases Control and Prevention, Nanning

All Listed Sponsors
collaborator

Guangxi Center for Disease Control and Prevention

OTHER_GOV

collaborator

Air Force Military Medical University, China

OTHER

lead

Walvax Biotechnology Co., Ltd.

INDUSTRY

NCT02285036 - Safety and Immunogenicity of a Newly 23-valent Pneumococcal Polysaccharide Vaccine in Chinese Adults and Children | Biotech Hunter | Biotech Hunter