A Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine

Sinovac

Status and phase: Completed; Phase 4

Conditions: Pneumococcal Infections

Treatments: Biological: Investigational 23-valent PPV; Biological: Control 23-valent PPV

Study type: Interventional

Funder types: Industry

Identifiers

NCT04989465

PRO-PPV-4001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 2 to 110 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

450 Participants (including 150 subjects aged 2\~17 years, 150 subjects aged18\~60 years and 150 subjects aged 61years and older ) received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd will be collected venous blood about 3.0\~3.5 ml.

Treatment:

Biological: Investigational 23-valent PPV

Control Group

Placebo Comparator group

Description:

150 Participants (including 50 subjects aged 2\~17 years, 50 subjects aged18\~60 years and 50 subjects aged 61years and older ) received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Chengdu Institute of Biological Products will be collected venous blood about 3.0\~3.5 ml.

Treatment:

Biological: Control 23-valent PPV