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
NCT ID: NCT04875533
Last Updated: 2024-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1425 participants
INTERVENTIONAL
2021-06-14
2022-05-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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20vPnC/Saline
20vPnC and saline
20vPnC
20vPnC
Saline
Saline
13vPnC/PPSV23
13vPnC and PPSV23
13vPnC
Pneumococcal conjugate vaccine
PPSV23
Pneumococcal polysaccharide vaccine
Interventions
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20vPnC
20vPnC
Saline
Saline
13vPnC
Pneumococcal conjugate vaccine
PPSV23
Pneumococcal polysaccharide vaccine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Seishinkai Inoue Hospital
Itoshima, Fukuoka, Japan
Women's Clinic LUNA NEXT STAGE
Naka-ku, Yokohama-Shi, Kanagawa, Japan
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Osaka, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, Japan
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, Japan
P-one Clinic, Keikokai Medical Corporation
Hachioji-shi, Tokyo, Japan
Hillside Clinic Jingumae
Shibuya-ku, Tokyo, Japan
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, Japan
SOUSEIKAI PS Clinic
Fukuoka, , Japan
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Inha University Hospital
Incheon, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Kangdong Sacred Heart Hospital
Seoul, , South Korea
Asan medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, , Taiwan
Countries
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References
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Haranaka M, Young Song J, Huang KC, de Solom R, Yamaji M, McElwee K, Kline M, Aizawa M, Peng Y, Scully I, Kogawara O, Gruber WC, Scott DA, Watson W. A phase 3 randomized trial of the safety and immunogenicity of 20-valent pneumococcal conjugate vaccine in adults >/= 60 years of age in Japan, South Korea, and Taiwan. Vaccine. 2024 Feb 15;42(5):1071-1077. doi: 10.1016/j.vaccine.2024.01.004. Epub 2024 Jan 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B7471009
Identifier Type: -
Identifier Source: org_study_id
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