20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naive Adults 60 Years of Age and Older in Japan, Korea, and Taiwa
- Conditions
- Prevention of pneumococcal disease
- Registration Number
- JPRN-jRCT2051210030
- Lead Sponsor
- Kawai Norisuke
- Brief Summary
20vPnC was observed to have a tolerability and safety profile similar to 13vPnC. Based on the robust immune responses and comparability to licensed pneumococcal vaccines (13vPnC and PPSV23) for applicable serotypes, these data support that 20vPnC will be protective against pneumococcal disease due to the 20 serotypes in adults 60 years of age and older in Japan, Korea, and Taiwan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1425
* Male or female participants 60 years of age and older at the time of consent.
* Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of study intervention. (For adults 60 through 64 years of age to be enrolled at Japan sites: Participants must have a preexisting chronic stable disease with an elevated risk for pneumococcal disease.)
* History of microbiologically proven invasive disease caused by S pneumoniae.
* Serious chronic disorder, including metastatic malignancy, severe COPD requiring supplemental oxygen, end-stage renal disease with or without dialysis, cirrhosis of the liver, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method