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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05092386
Recruitment Status : Not yet recruiting
First Posted : October 25, 2021
Last Update Posted : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd ( Sinovac Research and Development Co., Ltd. )

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

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13) Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( Pfizer PCV13) Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes 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
Primary Purpose: Prevention
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
Estimated Study Start Date : December 25, 2021
Estimated Primary Completion Date : January 25, 2022
Estimated Study Completion Date : December 25, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Group of One Dose
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
Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
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.

Experimental: Experimental Group of Two Doses
30 Participants aged 12~23 months will receive two doses of experimental vaccine on the schedule of month 0,2.
Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
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.

Experimental: Experimental Group of Three Doses
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 .
Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
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.

Experimental: Experimental Group of Four Doses
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
Biological: Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
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.

Active Comparator: Control Group of One Dose With WALVAX PCV13
30 Participants aged 2-5 years will receive one dose of control vaccine (WALVAX PCV13)
Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)
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.

Active Comparator: Control Group of Two Doses With WALVAX PCV13
30 Participants aged 12~23 months will receive two doses of control vaccine(WALVAX PCV13) on the schedule of month 0,2.
Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)
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.

Active Comparator: Control Group of Three Doses With WALVAX PCV13
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 .
Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)
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.

Active Comparator: Control Group of Three Doses With Pfizer PCV13
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
Biological: Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( Pfizer PCV13)
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 Measures :
  1. Safety index-incidence of adverse reactions [ Time Frame: Day 0-30 after each dose of experimental vaccine ]
    Incidence of adverse reactions 0 to 30 days after each dose of experimental vaccine


Secondary Outcome Measures :
  1. Safety index-incidence of adverse reactions [ Time Frame: Day 0-7 after each dose of experimental vaccine ]
    Incidence of adverse reactions 0 to 7 days after each dose of experimental vaccine

  2. Safety index-incidence of abnormal indicators [ Time Frame: Day 3 after vaccination after each dose of experimental vaccine ]
    Incidence of abnormal indicators of Blood routine, blood biochemistry and urine routine 3 days after vaccination in subjects aged 2 years and older

  3. Safety index-Incidence of serious adverse events during the safety observation period [ Time Frame: 1 month after vaccination ,6 months after primary immunization or 1 month after booster immunization ]
    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)

  4. Immunogenicity index-Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype [ Time Frame: Day 30 after vaccination ]
    Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype at 30 days after vaccination in subjects of all age groups

  5. Immunogenicity index-Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype [ Time Frame: Day 30 after vaccination ]
    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

  6. Immunogenicity index-Seropositive rates,GMCs and GMI of serum specific antibody [ Time Frame: Day 30 after vaccination ]
    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

  7. Immunogenicity index-Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT) [ Time Frame: Day 30 after vaccination ]
    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

  8. Immunogenicity index-Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC) [ Time Frame: Day 30 before and after booster immunization ]
    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

  9. Immunogenicity index-Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT) [ Time Frame: Day 30 before and after booster immunization ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Weeks to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05092386


Contacts
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Contact: Yanxia Wang, Master 13613816598 wangyanxia99@163.com
Contact: Shengli Xia, Master 13592610137

Locations
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China, Henan
Henan Center for Diseases Control and Prevention
Zhengzhou, Henan, China
Contact: Dacheng Zhan, master    15803925825    zdch68@163.com   
Sponsors and Collaborators
Sinovac Research and Development Co., Ltd.
Investigators
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Principal Investigator: Yanxia Wang, Master Henan Provincial Center for Disease Prevention and Control
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Responsible Party: Sinovac Research and Development Co., Ltd.
ClinicalTrials.gov Identifier: NCT05092386    
Other Study ID Numbers: PRO-PCV-1001
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs