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Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

Primary Purpose

Pneumococcal Infections

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)
Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( Pfizer PCV13)
Sponsored by
Sinovac Life Sciences Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infections

Eligibility Criteria

6 Weeks - 49 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy infants aged 2 months (minimum 6 weeks), healthy infants aged 3 months, healthy infants aged 7 ~ 11 months, healthy infants aged 12~ 23 months, healthy children aged 2~ 5 years, healthy adolescent and children aged 6~ 17 years, healthy adults aged 18~ 49 years；
  • Proven legal identification and vaccination certificate (vaccination certificate is required for those aged 5 and below)；
  • The subject and/or guardian can understand and voluntarily sign the informed consent form.

Exclusion Criteria:

  • Have received pneumococcal polysaccharide vaccine or pneumococcal polysaccharide conjugate vaccine;
  • Have Bacterial pneumonia or invasive pneumococcal infectious disease (IPD) caused by pneumococcus confirmed by sputum culture;
  • History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
  • Autoimmune disease or immunodeficiency / immunosuppression;
  • Severe chronic diseases, severe cardiovascular diseases, hypertension 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;
  • History of thyroidectomy, absence of spleen, functional absence of spleen, and absence of spleen or splenectomy due to any circumstance;
  • 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;
  • History of alcohol or drug abuse;
  • Receipt of blood products within in the past 3 months;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 14 days;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
  • Axillary temperature >37.0°C;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Sites / Locations

  • Henan Center for Diseases Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Experimental Group of One Dose

Experimental Group of Two Doses

Experimental Group of Three Doses

Experimental Group of Four Doses

Control Group of One Dose With WALVAX PCV13

Control Group of Two Doses With WALVAX PCV13

Control Group of Three Doses With WALVAX PCV13

Control Group of Three Doses With Pfizer PCV13

Arm Description

110 Participants (including 20 subjects aged 18~49 years, 20 subjects aged 6~17 years , 30 subjects aged2-5 years) will receive one dose of experimental vaccine

30 Participants aged 12~23 months will receive two doses of experimental vaccine on the schedule of month 0,2.

30 Participants aged 7~11 months will receive two doses of experimental vaccine on the primary immunization schedule of month 0,2 and one dose of booster immunization during the participants aged 12~15 months .

30 Participants aged 3 months will receive three doses of experimental vaccine on the primary immunization schedule of month 0,1,2 and one dose of booster immunization during the participants aged 12~15 months ; 30 Participants aged 2 months will receive three doses of experimental vaccine on the primary immunization schedule of month 0,2,4 and one dose of booster immunization during the participants aged 12~15 months

30 Participants aged 2-5 years will receive one dose of control vaccine (WALVAX PCV13)

30 Participants aged 12~23 months will receive two doses of control vaccine(WALVAX PCV13) on the schedule of month 0,2.

30 Participants aged 7~11 months will receive two doses of control vaccine(WALVAX PCV13) on the primary immunization schedule of month 0,2 and one dose of booster immunization during the participants aged 12~15 months .

30 Participants aged 2 months will receive three doses of control vaccine(Pfizer PCV13 on the primary immunization schedule of month 0,2,4 and one dose of booster immunization during the participants aged 12~15 months

Outcomes

Primary Outcome Measures

Safety index-incidence of adverse reactions
Incidence of adverse reactions 0 to 30 days after each dose of experimental vaccine

Secondary Outcome Measures

Safety index-incidence of adverse reactions
Incidence of adverse reactions 0 to 7 days after each dose of experimental vaccine
Safety index-incidence of abnormal indicators
Incidence of abnormal indicators of Blood routine, blood biochemistry and urine routine 3 days after vaccination in subjects aged 2 years and older
Safety index-Incidence of serious adverse events during the safety observation period
Incidence of serious adverse events during the safety observation period, including 1 month after vaccination in subject aged 6 years and older, and 6 months after primary immunization and 1 month after booster immunization in subject aged 2 months (minimum 6 weeks) to 5 years(if any)
Immunogenicity index-Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype
Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype at 30 days after vaccination in subjects of all age groups
Immunogenicity index-Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype
Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype at 30 days after vaccination in subjects of all age groups
Immunogenicity index-Seropositive rates，GMCs and GMI of serum specific antibody
Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMCs) and GMI of serum specific antibody at 30 days after primary immunization in subjects of all age groups
Immunogenicity index-Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT)
Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT)in subjects of all age groups at 30 days after primary immunization
Immunogenicity index-Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC)
Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC) in subjects aged 2 months (Minimum 6 weeks), 3 months and 7 ~ 11 months at 30 days before and after booster immunization
Immunogenicity index-Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT)
Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT) in subjects aged 2 months (Minimum 6 weeks), 3 months, and 7~ 11 months at 30 days before and after booster immunization

Full Information

First Posted
October 13, 2021
Last Updated
January 11, 2023
Sponsor
Sinovac Life Sciences Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05092386
Brief Title
Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
Official Title
An Open-label Combined Randomized Double-blind, Positive Control Clinical Trial in Subjects Aged 2 Months (Minimum 6 Weeks) and Above to Preliminary Evaluate the Safety and Immunogenicity of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Life Sciences 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 an open-label combined randomized double-blind, positive control phase Ⅰ clinical trial of the a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to preliminary evaluate the safety and immunogenicity of the study vaccine
Detailed Description
This study is an open-label combined randomized double-blind, positive control phase Ⅰ clinical trial in subjects aged 2 months (minimum 6 weeks) and above. The experimental vaccine was manufactured by Sinovac Research & Development Co., Ltd. .And one of the positive control vaccine was manufactured by WALVAX Biotechnology Co., Ltd( WALVAX PCV13) ,the other manufactured by Pfizer(Pfizer PCV13).A total of 310 subjects including 20 adults aged 18-49 years,20 adolescents and children aged 6~7 years ,60 children aged 2-5 years,60 infants aged 12~23 months,60 infants aged 7 ~11 months,60 infants aged 2 months (minimum 6 weeks), and 30 infants aged 3 months will be enrolled.Subjects will be assigned to receive one dose , two doses ,three doses or four doses of experimental vaccine or different positive control vaccines . Subjects aged 18-49 years will receive one dose of experimental vaccine.Subjects aged 6~17 years will receive one dose of experimental vaccine.Subjects aged 2~5 years will be randomly divided into two groups in a ratio of 1:1,and each group will receive one dose of experimental vaccine or control vaccine(WALVAX PCV13）.Subjects aged 7 ~ 11 months and subjects aged 12 ~23 months will be randomly divided into two groups in a 1:1 ratio,the subjects aged 12 ~ 23 months will receive two doses of experimental vaccine or control vaccine on the schedule of month 0,2 .Subjects aged 7 ~11 months will receive 3 doses of experimental vaccine or control vaccine (WALVAX PCV13）on the immunization schedule of month 0,2,4.Subjects aged 3 months will receive 4 doses of experimental vaccine.Subjects aged 2 months will be randomly divided into 2 groups in a 1:1 ratio and each group will receive 4 doses of experimental vaccine or control vaccine (Pfizer PCV13).

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 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Open label design will be adopted for children and adolescents aged 6-17 years and infants aged 3 months, and randomized, blind and positive control design was adopted for other populations
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group of One Dose
Arm Type
Experimental
Arm Description
110 Participants (including 20 subjects aged 18~49 years, 20 subjects aged 6~17 years , 30 subjects aged2-5 years) will receive one dose of experimental vaccine
Arm Title
Experimental Group of Two Doses
Arm Type
Experimental
Arm Description
30 Participants aged 12~23 months will receive two doses of experimental vaccine on the schedule of month 0,2.
Arm Title
Experimental Group of Three Doses
Arm Type
Experimental
Arm Description
30 Participants aged 7~11 months will receive two doses of experimental vaccine on the primary immunization schedule of month 0,2 and one dose of booster immunization during the participants aged 12~15 months .
Arm Title
Experimental Group of Four Doses
Arm Type
Experimental
Arm Description
30 Participants aged 3 months will receive three doses of experimental vaccine on the primary immunization schedule of month 0,1,2 and one dose of booster immunization during the participants aged 12~15 months ; 30 Participants aged 2 months will receive three doses of experimental vaccine on the primary immunization schedule of month 0,2,4 and one dose of booster immunization during the participants aged 12~15 months
Arm Title
Control Group of One Dose With WALVAX PCV13
Arm Type
Active Comparator
Arm Description
30 Participants aged 2-5 years will receive one dose of control vaccine (WALVAX PCV13)
Arm Title
Control Group of Two Doses With WALVAX PCV13
Arm Type
Active Comparator
Arm Description
30 Participants aged 12~23 months will receive two doses of control vaccine(WALVAX PCV13) on the schedule of month 0,2.
Arm Title
Control Group of Three Doses With WALVAX PCV13
Arm Type
Active Comparator
Arm Description
30 Participants aged 7~11 months will receive two doses of control vaccine(WALVAX PCV13) on the primary immunization schedule of month 0,2 and one dose of booster immunization during the participants aged 12~15 months .
Arm Title
Control Group of Three Doses With Pfizer PCV13
Arm Type
Active Comparator
Arm Description
30 Participants aged 2 months will receive three doses of control vaccine(Pfizer PCV13 on the primary immunization schedule of month 0,2,4 and one dose of booster immunization during the participants aged 12~15 months
Intervention Type
Biological
Intervention Name(s)
Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
Intervention Description
The investigational vaccine was manufactured by Sinovac Research & Development Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and diphtheria CRM197 in 0·5 mL of aluminum phosphate ,sodium chloride,polysorbate 80 and succinic acid per injection.
Intervention Type
Biological
Intervention Name(s)
Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)
Intervention Description
The control vaccine was manufactured by WALVAX Biotechnology Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and tetanus toxoid vector (TT) in 0·5 mL of aluminum phosphate ,disodium hydrogen phosphate and sodium dihydrogen phosphate per injection.
Intervention Type
Biological
Intervention Name(s)
Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( Pfizer PCV13)
Intervention Description
The control vaccine was manufactured by Pfizer. each for purified 13 serotypes of pneumococcal polysaccharide and tetanus toxoid vector (TT) in 0·5 mL of aluminum phosphate ,sodium chloride ,succinic acid ,polysorbate 80 and water for injection per injection.
Primary Outcome Measure Information:
Title
Safety index-incidence of adverse reactions
Description
Incidence of adverse reactions 0 to 30 days after each dose of experimental vaccine
Time Frame
Day 0-30 after each dose of experimental vaccine
Secondary Outcome Measure Information:
Title
Safety index-incidence of adverse reactions
Description
Incidence of adverse reactions 0 to 7 days after each dose of experimental vaccine
Time Frame
Day 0-7 after each dose of experimental vaccine
Title
Safety index-incidence of abnormal indicators
Description
Incidence of abnormal indicators of Blood routine, blood biochemistry and urine routine 3 days after vaccination in subjects aged 2 years and older
Time Frame
Day 3 after vaccination after each dose of experimental vaccine
Title
Safety index-Incidence of serious adverse events during the safety observation period
Description
Incidence of serious adverse events during the safety observation period, including 1 month after vaccination in subject aged 6 years and older, and 6 months after primary immunization and 1 month after booster immunization in subject aged 2 months (minimum 6 weeks) to 5 years(if any)
Time Frame
1 month after vaccination ,6 months after primary immunization or 1 month after booster immunization
Title
Immunogenicity index-Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype
Description
Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype at 30 days after vaccination in subjects of all age groups
Time Frame
Day 30 after vaccination
Title
Immunogenicity index-Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype
Description
Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype at 30 days after vaccination in subjects of all age groups
Time Frame
Day 30 after vaccination
Title
Immunogenicity index-Seropositive rates，GMCs and GMI of serum specific antibody
Description
Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMCs) and GMI of serum specific antibody at 30 days after primary immunization in subjects of all age groups
Time Frame
Day 30 after vaccination
Title
Immunogenicity index-Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT)
Description
Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT)in subjects of all age groups at 30 days after primary immunization
Time Frame
Day 30 after vaccination
Title
Immunogenicity index-Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC)
Description
Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC) in subjects aged 2 months (Minimum 6 weeks), 3 months and 7 ~ 11 months at 30 days before and after booster immunization
Time Frame
Day 30 before and after booster immunization
Title
Immunogenicity index-Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT)
Description
Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT) in subjects aged 2 months (Minimum 6 weeks), 3 months, and 7~ 11 months at 30 days before and after booster immunization
Time Frame
Day 30 before and after booster immunization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy infants aged 2 months (minimum 6 weeks), healthy infants aged 3 months, healthy infants aged 7 ~ 11 months, healthy infants aged 12~ 23 months, healthy children aged 2~ 5 years, healthy adolescent and children aged 6~ 17 years, healthy adults aged 18~ 49 years； Proven legal identification and vaccination certificate (vaccination certificate is required for those aged 5 and below)； The subject and/or guardian can understand and voluntarily sign the informed consent form. Exclusion Criteria: Have received pneumococcal polysaccharide vaccine or pneumococcal polysaccharide conjugate vaccine; Have Bacterial pneumonia or invasive pneumococcal infectious disease (IPD) caused by pneumococcus confirmed by sputum culture; History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema; Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; Autoimmune disease or immunodeficiency / immunosuppression; Severe chronic diseases, severe cardiovascular diseases, hypertension 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; History of thyroidectomy, absence of spleen, functional absence of spleen, and absence of spleen or splenectomy due to any circumstance; 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; History of alcohol or drug abuse; Receipt of blood products within in the past 3 months; Receipt of other investigational drugs in the past 30 days; Receipt of attenuated live vaccines in the past 14 days; Receipt of inactivated or subunit vaccines in the past 7 days; Acute diseases or acute exacerbation of chronic diseases in the past 7 days; Axillary temperature >37.0°C; According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanxia Wang, Master
Phone
13613816598
Email
wangyanxia99@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shengli Xia, Master
Phone
13592610137
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanxia Wang, Master
Organizational Affiliation
Henan Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Center for Diseases Control and Prevention
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dacheng Zhan, master
Phone
15803925825
Email
zdch68@163.com

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

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