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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY-UNBLINDED 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 JAPAN, KOREA, AND TAIWAN

NCT04875533•Pfizer

View on ClinicalTrials.gov

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 Japan, Korea, and Taiwan

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (28)

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

Key Dates

Start Date

June 14, 2021

Primary Completion Date

May 13, 2022

Completion Date

May 13, 2022

Last Updated

November 5, 2024

Enrollment

1,425

ACTUAL participants

Conditions

Pneumococcal Disease

Interventions

20vPnC

BIOLOGICAL

Saline

OTHER

13vPnC

BIOLOGICAL

PPSV23

BIOLOGICAL

Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15

NCT06731374

Pneumococcal DiseasePneumococcal Carriage

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RECRUITINGPHASE3

A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People

NCT06044077

Pneumococcal Disease

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ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15

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