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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-06

Study Completion Date

2026-02-03

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Pneumococcal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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20vPnC

Single dose of 20-valent pneumococcal conjugate vaccine

Group Type EXPERIMENTAL

20vPnC

Intervention Type BIOLOGICAL

20 valent pneumococcal conjugate vaccine

13vPnC

Single dose of 13-valent pneumococcal conjugate vaccine

Group Type EXPERIMENTAL

13vPnC

Intervention Type BIOLOGICAL

13 valent pneumococcal conjugate vaccine

Interventions

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20vPnC

20 valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

13vPnC

13 valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes