Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
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
1 other identifier
interventional
310
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2021
CompletedFirst Posted
Study publicly available on registry
October 25, 2021
CompletedStudy Start
First participant enrolled
January 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 28, 2024
CompletedJanuary 28, 2026
January 1, 2026
1.4 years
October 13, 2021
January 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Safety index-incidence of adverse reactions
Incidence of adverse reactions 0 to 30 days after each dose of experimental vaccine
Day 0-30 after each dose of experimental vaccine
Secondary Outcomes (9)
Safety index-incidence of adverse reactions
Day 0-7 after each dose of experimental vaccine
Safety index-incidence of abnormal indicators
Day 3 after vaccination after each dose of experimental vaccine
Safety index-Incidence of serious adverse events during the safety observation period
1 month after vaccination ,6 months after primary immunization or 1 month after booster immunization
Immunogenicity index-Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype
Day 30 after vaccination
Immunogenicity index-Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype
Day 30 after vaccination
- +4 more secondary outcomes
Study Arms (8)
Experimental Group of One Dose
EXPERIMENTAL110 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
Experimental Group of Two Doses
EXPERIMENTAL30 Participants aged 12\~23 months will receive two doses of experimental vaccine on the schedule of month 0,2.
Experimental Group of Three Doses
EXPERIMENTAL30 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 .
Experimental Group of Four Doses
EXPERIMENTAL30 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
Control Group of One Dose With WALVAX PCV13
ACTIVE COMPARATOR30 Participants aged 2-5 years will receive one dose of control vaccine (WALVAX PCV13)
Control Group of Two Doses With WALVAX PCV13
ACTIVE COMPARATOR30 Participants aged 12\~23 months will receive two doses of control vaccine(WALVAX PCV13) on the schedule of month 0,2.
Control Group of Three Doses With WALVAX PCV13
ACTIVE COMPARATOR30 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 Group of Three Doses With Pfizer PCV13
ACTIVE COMPARATOR30 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
Interventions
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.
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.
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
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henan Center for Diseases Control and Prevention
Zhengzhou, Henan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanxia Wang, Master
Henan Provincial Center for Disease Prevention and Control
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2021
First Posted
October 25, 2021
Study Start
January 3, 2023
Primary Completion
May 26, 2024
Study Completion
May 28, 2024
Last Updated
January 28, 2026
Record last verified: 2026-01