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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Disease

Treatments: Biological: 13vPnC; Other: Saline; Biological: PPSV23; Biological: 20vPnC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04875533

B7471009

Details and patient eligibility

About

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

Enrollment: 1,425 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,425 participants in 2 patient groups

20vPnC/Saline

Experimental group

Description:

20vPnC and saline

Treatment:

Biological: 20vPnC

Other: Saline

13vPnC/PPSV23

Active Comparator group

Description:

13vPnC and PPSV23

Treatment:

Biological: PPSV23

Biological: 13vPnC