NCT04875533

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,425 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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

Conditions

• Pneumococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	20vPnC	20vPnC
OTHER	Saline	Saline
BIOLOGICAL	13vPnC	Pneumococcal conjugate vaccine
BIOLOGICAL	PPSV23	Pneumococcal polysaccharide vaccine

Timeline

• Start date: 2021-06-14
• Primary completion: 2022-05-13
• Completion: 2022-05-13
• First posted: 2021-05-06
• Last updated: 2024-11-05
• Results posted: 2023-11-28

Locations

28 sites across 3 countries: Japan, South Korea, Taiwan

Regulatory

• FDA-regulated drug study