Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
NCT ID: NCT05092386
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
310 participants
INTERVENTIONAL
2023-01-03
2024-05-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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
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 Group of Two Doses
30 Participants aged 12\~23 months will receive two doses of experimental vaccine on the schedule of month 0,2.
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 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 .
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 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
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.
Control Group of One Dose With WALVAX PCV13
30 Participants aged 2-5 years will receive one dose of control vaccine (WALVAX PCV13)
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.
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.
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.
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 .
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.
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
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
6 Weeks
49 Years
ALL
Yes
Sponsors
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Sinovac Life Sciences Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yanxia Wang, Master
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial Center for Disease Prevention and Control
Locations
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Henan Center for Diseases Control and Prevention
Zhengzhou, Henan, China
Countries
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Other Identifiers
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PRO-PCV-1001
Identifier Type: -
Identifier Source: org_study_id