A Clinical Trial to Observe the Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Target Population

NCT ID: NCT07071701

Last Updated: 2025-07-17

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

COMPLETED

Total Enrollment

19267 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-02

Study Completion Date

2024-04-05

Brief Summary

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An open clinical trial of a 23-valent pneumococcal polysaccharide vaccine (PPV23) developed by Sinovac Life Science Co., Ltd was conducted to evaluate the safety of Sinovac PPV23 in target population of individuals aged 2 years and above. All participants received 1 dose of PPV23 and self-selected whether to receive 1 dose of influenza vaccine at the same time.

Detailed Description

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Conditions

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Pneumococcal Infectious Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acitive safety surveillance group

23-valent pneumococcal polysaccharide vaccine

Intervention Type BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

Influenza vaccine

Intervention Type BIOLOGICAL

Influenza vaccine

Passive safety surveillance group

23-valent pneumococcal polysaccharide vaccine

Intervention Type BIOLOGICAL

23-valent pneumococcal polysaccharide vaccine

Influenza vaccine

Intervention Type BIOLOGICAL

Influenza vaccine

Interventions

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23-valent pneumococcal polysaccharide vaccine

23-valent pneumococcal polysaccharide vaccine

Intervention Type BIOLOGICAL

Influenza vaccine

Influenza vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Have voluntarily and at their own expense received the 23-valent pneumococcal polysaccharide vaccine;
* Participants and/or their guardians are able to understand and voluntarily participate in this study and sign an informed consent form;
* Provide valid legal identification.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sinovac Biotech Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jiangsu Provincial Center for Disease Prevention and Control

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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PRO-PPV-MA4002-JS

Identifier Type: -

Identifier Source: org_study_id

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