Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults and Elderly
This trial is active, not recruiting.
|Treatments||investigational 23-valent ppv, control 23-valent ppv|
|Sponsor||Sinovac Biotech Co., Ltd|
|Start date||April 2015|
|End date||June 2015|
|Trial size||1760 participants|
|Trial identifier||NCT02451969, PRO-PPV-3001|
The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) in healthy children, adults and elderly. The control vaccine is a commercialized 23-valent PPV.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
The seroconversion rates (SCR) of each of the 23 pneumococcal serotypes
time frame: 28 days
The incidences of adverse events (AEs)
time frame: 28 days
The increases of relative antibody concentration against each of the 23 pneumococcal serotypes
time frame: 28 days
Male or female participants at least 2 years old.
Inclusion Criteria: - Healthy volunteer ≥ 2 years old; - Proven legal identity; - Written consent of the guardian of participants < 18 years old, and written consent of the participant ≥ 12 years old; - Complying with the requirement of the study protocol; Exclusion Criteria: - Prior vaccination with pneumococcal vaccine; - History of bacterial pneumonia within 3 years prior to this study; - Pregnant, breast feeding, or women expected to conceive within 60 days after vaccination; - History of allergy to any vaccine or vaccine ingredient; - Receipt of any of the following products: 1. Blood product within 3 months prior to study entry; 2. Any live attenuated vaccine within 28 days prior to study entry; 3. Any subunit vaccine or inactivated vaccine within 14 days prior to study entry; 4. Any immunosuppressant within 6 month prior to study entry; - Congenital malformation, developmental disorders, serious chronic diseases, autoimmune disease, immunodeficiency, serious cardiovascular disease, diabetes, hypertension that cannot be stabilized by medication, liver or kidney disease, or malignant tumor; - History of asthma, thyroidectomy, angioneurotic edema, severe nervous system disease or mental illness; without spleen or splenectomy; diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities), or obvious bruising or coagulation disorders; - Acute disease or acute stage of chronic disease within 7 days prior to study entry; - Axillaty temperature > 37.0 °C; - Any other factor that in the opinion of the investigator suggesting the volunteer is unsuitable for this study; - Participants with the following conditions from day 0 - 28 would be included in the full analysis set (FAS), but would be excluded from the per protocol set (PPS): 1. Receipt of any other investigational or unregistered product (drug or vaccine); 2. Receipt of immunosuppressant (corticosteroid dosage that equivalent to or above 0.5 mg prednisone/kg weight/day) for > 14 days, except for inhalant or locally administrated corticosteroid; 3. Receipt of immunoglobulin and/or blood product; 4. Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection);
|Official title||Phase III Safety and Immunogenicity Study of 23-valent Pneumococcal Polysaccharide Vaccine: A Double-blind, Randomized and Controlled Clinical Trial With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Children, Adults, and Elderly|
|Principal investigator||Weiping Ru, BS|
|Description||This study is a randomized, double-blind, single-center, controlled phase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of an investigational 23-valent pneumococcal polysaccharide vaccine (PPV) manufactured by Sinovac Biotech Co., Ltd. The primary objective of this study is to demonstrate that the immunogenicity of the investigational vaccine is non-inferior to that of a commercialized 23-valent PPV manufactured by Chengdu Institute of Biological products Co., Ltd.; the secondary objective is to assess the safety of the investigational and control vaccines. Participants will be grouped into three cohorts by age: child cohort (2 - 17 years old), adult cohort (18 - 60 years old) and elderly cohort (≥ 61 years old). In each cohort, the participants will be randomly assigned into experimental group or control group in the ratio 1:1.|
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