Status:
COMPLETED
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Disease
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
A phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults 60 years of age and older in Japa...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.)
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
June 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2022
Estimated Enrollment :
1425 Patients enrolled
Trial Details
Trial ID
NCT04875533
Start Date
June 14 2021
End Date
May 13 2022
Last Update
November 5 2024
Active Locations (28)
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1
Seishinkai Inoue Hospital
Itoshima, Fukuoka, Japan, 819-1104
2
Women's Clinic LUNA NEXT STAGE
Naka-ku, Yokohama-Shi, Kanagawa, Japan, 231-0861
3
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Osaka, Japan, 532-0003
4
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, Japan, 565-0853