Clinical trial NCT05092386: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pneumococcal Infections
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 310
Sex: ALL
Minimum age (years): 6
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Safety index-incidence of adverse reactions
timeFrame: Day 0-30 after each dose of experimental vaccine
Secondary outcomes:
measure: Safety index-incidence of adverse reactions
timeFrame: Day 0-7 after each dose of experimental vaccine
measure: Safety index-incidence of abnormal indicators
timeFrame: Day 3 after vaccination after each dose of experimental vaccine
measure: Safety index-Incidence of serious adverse events during the safety observation period
timeFrame: 1 month after vaccination ,6 months after primary immunization or 1 month after booster immunization
measure: Immunogenicity index-Geometric mean concentrations (GMC) and GMI of specific IgG for each serotype
timeFrame: Day 30 after vaccination
measure: Immunogenicity index-Geometric mean titers (GMT) and GMI of serotype specific opsonophagocytic antibody OPA for each serotype
timeFrame: Day 30 after vaccination
measure: Immunogenicity index-Seropositive rates，GMCs and GMI of serum specific antibody
timeFrame: Day 30 after vaccination
measure: Immunogenicity index-Proportion of OPA ≥1:8 of each serum and geometric mean titer (GMT)
timeFrame: Day 30 after vaccination
measure: Immunogenicity index-Seropositive rates of IgG concentration ≥0.35μg/mL, ≥1.0μg/mL, geometric mean concentration (GMC)
timeFrame: Day 30 before and after booster immunization
measure: Immunogenicity index-Proportion of OPA ≥1:8 for each serotype and geometric mean titer (GMT)
timeFrame: Day 30 before and after booster immunization
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Center for Diseases Control and Prevention
state: Henan
Study officials:
affiliation: Henan Provincial Center for Disease Prevention and Control
name: Yanxia Wang, Master
role: PRINCIPAL_INVESTIGATOR
References: