A Study to Learn About How Safe and Effective is 20vPnC and 13vPnC Vaccines in Chinese Adults

Pfizer

Status and phase: Active, not recruiting; Phase 1

Conditions: Pneumococcal Disease

Treatments: Biological: 20vPnC; Biological: 13vPnC

Study type: Interventional

Funder types: Industry

Identifiers

NCT07019909

B7471039

Details and patient eligibility

About

This Phase 1, randomized, double-blind, third-party-unblinded study will be conducted at investigational sites in China. The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC in Chinese adults 50 years of age and older who did not receive any of pneumococcal vaccine in the past

Full description

The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC vaccines in Chinese adults. This study is seeking for participants who:

• are 50 years of age and older
• did not receive any of vaccines used to treat infections caused by the bacteria called Streptococcus pneumonia in the past.

The participants will be grouped by three age groups:

• Adults between 50 to 59 years of age
• Adults between 60 to 64 years of age
• Adults who are 65 years of age or above

All participants in this study will receive a single dose of 20vPnC or 13vPnC at study clinic. The study will look at the experiences of people receiving 20vPnC and 13vPnC. This will help decide if the study vaccine is safe.

The total duration of taking part in the study will be around 6 months, with 6 visits.

Enrollment: 400 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion criteria:

1.Generally healthy adults including those with preexisting stable disease determined to be eligible based on clinical assessment, medical history and clinical judgment.

Key exclusion criteria:

1. History of microbiologically-proven invasive disease caused by Streptococcus pneumoniae
2. 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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400 participants in 2 patient groups

20vPnC

Experimental group

Description:

Single dose of 20-valent pneumococcal conjugate vaccine

Treatment:

Biological: 20vPnC

13vPnC

Experimental group

Description:

Single dose of 13-valent pneumococcal conjugate vaccine

Treatment:

Biological: 13vPnC