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COMPLETEDPHASE4

A Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine

An Open Phase Ⅳ Clinical Trial to Evaluate the Immunity Persistence After Single Dose of 23-valent Pneumococcal Polysaccharide Vaccine

NCT04989465•Sinovac Biotech Co., Ltd

View on ClinicalTrials.gov

Summary

This an open phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the immunity persistence after single dose of 23-valent pneumococcal polysaccharide vaccine.

Detailed Description

This study is an open phase Ⅳ clinical trial to evaluate the immunity persistence after single dose of 23-valent pneumococcal polysaccharide vaccine.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd,the control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd..A total of 600 subjects including 450 subjects in the experimental group and 150 subjects in the control group who participated in the second stage of phase Ⅲ clinical trial (PPS)will be enrolled .Based on the age at the time of enrollment in the phase Ⅲ study, there will be 150 participants in each age group (2-17 years old group, 18-60 years old group and ≥61 years old) in the experimental group and 50 participants in each age group in the control group .3.0-3.5ml of venous blood will be collected from all subjects after enrollment.

Eligibility

Age

2 - 110 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects who participated in the second stage of phase Ⅲ clinical trial (PPS);
•The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form);
•Proven legal identity.

Exclusion Criteria

•Have received any pneumococcal vaccine after participating the phase III clinical trial of 23-valent pneumococcal polysaccharide vaccine ;
•History of invasive disease caused by streptococcus pneumoniae after participating the phase III clinical trial of 23-valent pneumococcal polysaccharide vaccine;
•Autoimmune disease or immunodeficiency / immunosuppression was known after participating the phase III clinical trial of 23-valent pneumococcal polysaccharide vaccine;
•History of immunosuppressive therapy after participating the phase III clinical trial of 23-valent pneumococcal polysaccharide vaccine;
•According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Locations (1)

Kaifeng County Center for Disease Control and Prevention

Kaifeng, Henan, China

Key Dates

Start Date

September 10, 2021

Primary Completion Date

September 13, 2021

Completion Date

September 13, 2021

Last Updated

August 12, 2022

Enrollment

600

ACTUAL participants

Conditions

Pneumococcal Infections

Interventions

Investigational 23-valent PPV

BIOLOGICAL

Control 23-valent PPV

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine

Inclusion Criteria

Exclusion Criteria

In-depth Analysis of the Immune Responses in the Upper Respiratory Tract in Older Adults Infected or Colonized With Streptococcus Pneumoniae (Spn)

Immunogenicity and Safety PCV-20 of the Vaccine Administered During an Acute Febrile Illness in Adults

The Effect of AUDIT and Feedback on Pneumococcal Vaccination Coverage

Immunization To Prevent Acute COPD Exacerbations

Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)

Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)