Clinical trial
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
Name
PRO-PCV-1001
Description
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 arms
Trial start
2023-01-03
Estimated PCD
2023-12-30
Trial end
2023-12-30
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Experimental Group of Four Doses, Experimental Group of One Dose, Experimental Group of Three Doses, Experimental Group of Two Doses
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.
Arms:
Control Group of One Dose With WALVAX PCV13, Control Group of Three Doses With WALVAX PCV13, Control Group of Two Doses With WALVAX PCV13
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.
Arms:
Control Group of Three Doses With Pfizer PCV13
Size
310
Primary endpoint
Safety index-incidence of adverse reactions
Day 0-30 after each dose of experimental vaccine
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 310, 'type': 'ESTIMATED'}}
Updated at
2023-01-12
1 organization
2 products
1 indication
Organization
Sinovac Life SciencesIndication
Pneumococcal Infections