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

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections
• Intervention / Treatment: Biological: Investigational 23-valent PPV; Biological: Control 23-valent PPV

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.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Henan
    • Kaifeng, Henan, China, 475100
      • Kaifeng County Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 110 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental Group; 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.	Biological: Investigational 23-valent PPV; The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in 0·5 mL of sodium chloride, sodium dihydrogen phosphate and disodium hydrogen phosphate per injection
PLACEBO_COMPARATOR: Control Group; 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.	Biological: Control 23-valent PPV; The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd. 25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in 0·5 mL of light disodium phenol phosphate, sodium hydrogen phosphate and sodium chloride per injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity index 1-geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody	Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody at day 28 after the full vaccination in all subjects	From the beginning of the vaccination to 28 days after the full vaccination
Immunogenicity index 2-geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody	Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 6 years after the full vaccination in all subjects	From the beginning of the vaccination to 6 years after the full vaccination

Collaborators and Investigators

• Sponsor: Sinovac Biotech Co., Ltd
• Investigators: Principal Investigator: Lili Huang, Master, Henan Provincial Center for Disease Prevention and Control

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 10, 2021
• Primary Completion (ACTUAL): September 13, 2021
• Study Completion (ACTUAL): September 13, 2021

Study Registration Dates

• First Submitted: July 25, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (ACTUAL): August 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections
• Other Study ID Numbers: PRO-PPV-4001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No