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Lot-to-lot Consistency of 23-valent Pneumococcal Polysaccharide Vaccine

Primary Purpose

Pneumococcal Infections

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Experimental 23-valent Pneumococcal
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infections

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adults aged 40-65 years in stable health; The subjects can understand and voluntarily sign the informed consent form; Proven legal identity. Exclusion Criteria: Have received any pneumococcal vaccine; History bacterial pneumonia or invasive pneumococcal infectious diseases caused by pneumococci and confirmed by culture; Women of childbearing age (menarche to premenopause) are pregnant (including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month; History of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema; Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.; Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; Autoimmune disease or immune deficiency/immunosuppression; Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation; Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; A long history of alcohol or drug abuse; Receipt of blood products within in the past 3 months; Receipt of other investigational drugs within 30 days prior to receiving the investigational vaccine; Receipt of attenuated live vaccines or COVID-19 vaccines in the past 14 days; Receipt of inactivated or subunit vaccines in the past 7 days; Onset of various acute or chronic diseases within 7 days prior to the study; Underarm body temperature before vaccination>37.0°C; The subjects participated in other clinical trials during the follow-up period or will be planned to participate other clinical trials within 1 months; According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Sites / Locations

  • The First People's Hospital of Yuanping Medical Group
  • Salt Lake District Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Experimental Vaccine-lot 1

Experimental Vaccine-lot 2

Experimental Vaccine-lot 3

Arm Description

Participants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 1.

Participants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 2.

Participants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 3.

Outcomes

Primary Outcome Measures

Immunogenicity index-Geometric Mean Concentration (GMC)
GMC for serotype-specific pneumococcal immunoglobulin G (IgG) antibody 30 days after vaccination.

Secondary Outcome Measures

Immunogenicity index-Geometric Mean Increase (GMI)
GMI for serotype-specific pneumococcal IgG antibody 30 days after vaccination.
Immunogenicity index-Seroconversion rate (2-fold increase rate)
Seroconversion rate (2-fold increase rate) for serotype-specific pneumococcal IgG antibody 30 days after vaccination.
Safety index-Incidence of adverse reactions
Incidence of adverse reactions within 30 days after vaccination
Safety index-Incidence of adverse reactions
Incidence of adverse reactions within 7 days after vaccination
Safety index-Incidence of serious adverse events
Incidence of serious adverse events within 30 days after vaccination.

Full Information

First Posted
February 7, 2023
Last Updated
September 15, 2023
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05731115
Brief Title
Lot-to-lot Consistency of 23-valent Pneumococcal Polysaccharide Vaccine
Official Title
A Randomized, Double-blind Clinical Trial to Evaluate the Lot Consistency, Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine in Adults Aged 40-65 Years
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
May 5, 2023 (Actual)
Study Completion Date
May 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a randomized, double-blind 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 consistency of three consecutive lots, immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale in participants aged 40-65 years.
Detailed Description
This study is a randomized, double-blind phase Ⅳ clinical trial in subjects aged 40-65 years to evaluate the lot-to-lot consistency,immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 1800 subjects will be enrolled.The subjects will be randomly divided into three groups in a ratio of 1:1:1 to received one dose of vaccine on day 0.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Vaccine-lot 1
Arm Type
Experimental
Arm Description
Participants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 1.
Arm Title
Experimental Vaccine-lot 2
Arm Type
Experimental
Arm Description
Participants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 2.
Arm Title
Experimental Vaccine-lot 3
Arm Type
Experimental
Arm Description
Participants (n=600) aged 40-65 years will receive one dose of 23-valent pneumococcal polysaccharide vaccine of commercial scale production lot 3.
Intervention Type
Biological
Intervention Name(s)
Experimental 23-valent Pneumococcal
Intervention Description
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 mixture per injection.
Primary Outcome Measure Information:
Title
Immunogenicity index-Geometric Mean Concentration (GMC)
Description
GMC for serotype-specific pneumococcal immunoglobulin G (IgG) antibody 30 days after vaccination.
Time Frame
30 days after vaccination
Secondary Outcome Measure Information:
Title
Immunogenicity index-Geometric Mean Increase (GMI)
Description
GMI for serotype-specific pneumococcal IgG antibody 30 days after vaccination.
Time Frame
30 days after vaccination
Title
Immunogenicity index-Seroconversion rate (2-fold increase rate)
Description
Seroconversion rate (2-fold increase rate) for serotype-specific pneumococcal IgG antibody 30 days after vaccination.
Time Frame
30 days after vaccination
Title
Safety index-Incidence of adverse reactions
Description
Incidence of adverse reactions within 30 days after vaccination
Time Frame
Within 30 days after vaccination
Title
Safety index-Incidence of adverse reactions
Description
Incidence of adverse reactions within 7 days after vaccination
Time Frame
Within 7 days after vaccination
Title
Safety index-Incidence of serious adverse events
Description
Incidence of serious adverse events within 30 days after vaccination.
Time Frame
Within 30 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults aged 40-65 years in stable health; The subjects can understand and voluntarily sign the informed consent form; Proven legal identity. Exclusion Criteria: Have received any pneumococcal vaccine; History bacterial pneumonia or invasive pneumococcal infectious diseases caused by pneumococci and confirmed by culture; Women of childbearing age (menarche to premenopause) are pregnant (including positive urine pregnancy test), breastfeeding or planning pregnancy within 1 month; History of asthma, allergy to vaccines or vaccine components, and serious adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema; Severe chronic diseases,such as severe cardiovascular diseases, hypertension(Systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg) and diabetes that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.; Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; Autoimmune disease or immune deficiency/immunosuppression; Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation; Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; A long history of alcohol or drug abuse; Receipt of blood products within in the past 3 months; Receipt of other investigational drugs within 30 days prior to receiving the investigational vaccine; Receipt of attenuated live vaccines or COVID-19 vaccines in the past 14 days; Receipt of inactivated or subunit vaccines in the past 7 days; Onset of various acute or chronic diseases within 7 days prior to the study; Underarm body temperature before vaccination>37.0°C; The subjects participated in other clinical trials during the follow-up period or will be planned to participate other clinical trials within 1 months; According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunong Zhang
Organizational Affiliation
Shanxi Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First People's Hospital of Yuanping Medical Group
City
Yuanping
State/Province
Shanxi
ZIP/Postal Code
034199
Country
China
Facility Name
Salt Lake District Center for Disease Control and Prevention
City
Yuncheng
State/Province
Shanxi
ZIP/Postal Code
044000
Country
China

12. IPD Sharing Statement

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Lot-to-lot Consistency of 23-valent Pneumococcal Polysaccharide Vaccine

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