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Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine

Primary Purpose

Pneumococcal Infections

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Experimental 23-valent PPV

Control 23-valent PPV

About this trial

This is an interventional prevention trial for Pneumococcal Infections

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Children aged 2 years and above in stable health;
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.If the subject aged 16 to 17 years with full capacity for civil conduct and his/her labor income is his/her main source of living, the informed consent can be signed only by the subject himself/herself);
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;
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 3 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

Linwei District Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

1200 participants(including 600 subjects aged 2~17 years,240 subjects aged 18~59 years and 360 subjects aged 60 years and above)received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd

600 participants(including 300 subjects aged 2~17 years,120 subjects aged 18~59 years and 180 subjects aged 60 years and above)received one dose of 23-valent pneumococcal polysaccharide vaccine manufactured by Merck Sharp & Dohme.

Outcomes

Primary Outcome Measures

Immunogenicity index-Seroconversion rate (2-fold increase rate)

Seroconversion rate (2-fold increase rate)for serotype specificity (3, 6B, 14, 19A, 19F, 23F) of pneumococcal immunoglobulin G (IgG) antibody 30 days after vaccination.

Secondary Outcome Measures

Immunogenicity index-Geometric Mean Concentration (GMC)

Geometric Mean Concentration (GMC) for serotype specificity (3, 6B, 14, 19A, 19F, 23F) of pneumococcal IgG antibody 30 days after vaccination.

Immunogenicity index-Geometric Mean Increase (GMI)

Geometric Mean Increase (GMI) for serotype specificity (3, 6B, 14, 19A, 19F, 23F) of pneumococcal IgG antibody 30 days after vaccination.

Immunogenicity index-Seroconversion rate

Seroconversion rate for serotype specificity （1、2、4、5、7F、8、9N、9V、10A、11A、12F、15B、17F、18C、20、22F and 33F）of pneumococcal IgG antibody 30 days after vaccination.

Immunogenicity index-GMC

Geometric Mean Concentration (GMC) for serotype specificity （1、2、4、5、7F、8、9N、9V、10A、11A、12F、15B、17F、18C、20、22F and 33F）of pneumococcal IgG antibody 30 days after vaccination.

Immunogenicity index-GMI

Geometric Mean Increase (GMI) for serotype specificity （1、2、4、5、7F、8、9N、9V、10A、11A、12F、15B、17F、18C、20、22F and 33F）of 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

NCT ID

NCT05477693

First Posted

July 26, 2022

Last Updated

September 15, 2023

Sponsor

Sinovac Biotech Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05477693

Brief Title

Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine

Official Title

A Randomized, Double-blind, Positive-controlled Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine in Population Aged 2 Years and Older

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

October 25, 2022 (Actual)

Primary Completion Date

April 10, 2023 (Actual)

Study Completion Date

April 10, 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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a randomized, double-blind, positive-controlled 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 immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.

Detailed Description

This study is a randomized, double-blind, positive-controlled phase Ⅳ clinical trial to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd,the control vaccine was manufactured by Merck Sharp & Dohme.A total of 1800 subjects including 900 subjects aged 2~17 years,360 subjects aged 18~59 years and 540 subjects aged 60 years and above will be enrolled.Subjects in each age group will be randomly divided into two groups according to the ratio of 2:1, and received one dose of experimental vaccine or control vaccine.

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

Participant

Allocation

Randomized

Enrollment

1800 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Group

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Experimental 23-valent PPV

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, sodium dihydrogen phosphate and disodium hydrogen phosphate per injection.

Intervention Type

Biological

Intervention Name(s)

Control 23-valent PPV

Intervention Description

The control vaccine was manufactured by Merck Sharp & Dohme, Ltd. Purified capsular polysaccharides from 23 Streptococcus in 0.5 mL of pneumoniae types 0.25% phenol and sodium chloride.

Primary Outcome Measure Information:

Title

Immunogenicity index-Seroconversion rate (2-fold increase rate)

Description

Seroconversion rate (2-fold increase rate)for serotype specificity (3, 6B, 14, 19A, 19F, 23F) of pneumococcal immunoglobulin G (IgG) antibody 30 days after vaccination.

Time Frame

30 days after vaccination

Secondary Outcome Measure Information:

Title

Immunogenicity index-Geometric Mean Concentration (GMC)

Description

Geometric Mean Concentration (GMC) for serotype specificity (3, 6B, 14, 19A, 19F, 23F) of pneumococcal IgG antibody 30 days after vaccination.

Time Frame

30 days after vaccination

Title

Immunogenicity index-Geometric Mean Increase (GMI)

Description

Geometric Mean Increase (GMI) for serotype specificity (3, 6B, 14, 19A, 19F, 23F) of pneumococcal IgG antibody 30 days after vaccination.

Time Frame

30 days after vaccination

Title

Immunogenicity index-Seroconversion rate

Description

Seroconversion rate for serotype specificity （1、2、4、5、7F、8、9N、9V、10A、11A、12F、15B、17F、18C、20、22F and 33F）of pneumococcal IgG antibody 30 days after vaccination.

Time Frame

30 days after vaccination

Title

Immunogenicity index-GMC

Description

Time Frame

30 days after vaccination

Title

Immunogenicity index-GMI

Description

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

2 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Children aged 2 years and above in stable health; 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.If the subject aged 16 to 17 years with full capacity for civil conduct and his/her labor income is his/her main source of living, the informed consent can be signed only by the subject himself/herself); 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; 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 3 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

Weijun Hu

Organizational Affiliation

Shanxi Provincial Center for Disease Prevention and Control

Official's Role

Principal Investigator

Facility Information:

Facility Name

Linwei District Center for Disease Control and Prevention

City

Weinan

State/Province

Shanxi

ZIP/Postal Code

710000

Country

China

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine

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