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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
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

NCT04875533

CompletedPhase 3

Sponsor: Pfizer

Conditions: Pneumococcal Disease

Interventions: 20vPnC, Saline, 13vPnC, PPSV23

Countries: Japan, South Korea, Taiwan

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 overview

Sex: ALL

Age: 60 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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)
  • Itoshima, Fukuoka, Japan
  • Naka-ku, Yokohama-Shi, Kanagawa, Japan
  • Osaka, Osaka, Japan
  • Suita-shi, Osaka, Japan
  • Chuo-ku, Tokyo, Japan
  • Chuo-ku, Tokyo, Japan
  • Hachioji-shi, Tokyo, Japan
  • Shibuya-ku, Tokyo, Japan
  • Shinjuku-ku, Tokyo, Japan
  • Fukuoka, Japan
  • Ansan-si, Gyeonggi-do, South Korea
  • Suwon, Gyeonggi-do, South Korea
  • Suwon, Gyeonggi-do, South Korea
  • Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • Daegu, South Korea
  • Incheon, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • New Taipei City, Taiwan
  • New Taipei City, Taiwan
  • Taichung, Taiwan
  • Tainan, Taiwan
  • Taipei, Taiwan
  • Taoyuan City, Taiwan