A Randomized, Double-Blind Phase Ⅲb Clinical Trial to Evaluate the Lot-to-Lot Consistency, Immunogenicity and Safety of 13-Valent Pneumococcal Conjugate Vaccine in Children Aged 2 to 5 Years
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,125
- 试验地点
- 1
- 主要终点
- Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) 30 days after vaccination
研究概览
简要总结
A Phase IIIb clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13)developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2 to 5 years.
The objective of the study is to evaluate the the Lot-to-Lot consistency, immunogenicity and safety of Sinovac PCV13. The trial is a randomized, double-blind phase IIIb clinical trial.
详细描述
A phase IIIb clinical trial of the study of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese children aged approximately 2 to 5 years.
The trial is a randomized, double-blind study. The objective of this study is to evaluate theLot-to-Lot consistency, immunogenicity and safety of PCV13 manufactured by Sinovac Life Science Co., Ltd.
A total of at least 1125 participants will be enrolled. Participants wiil be randomized in a 1:1:1 ratio into three groups to receive different lots of commercially manufactured PCV13.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 2 to 5 years with stable health status
- •Participants and their legal representative provide legal proof of identity, as well as vaccination record
- •Participants' legal representative understand and voluntarily sign the informed consent form
- •Willing and able to comply with all scheduled visits, sample collection, vaccination and other study procedures, and maintain accessible contact throughout the study period.
排除标准
- •Received any pneumococcal vaccine prior to enrollment
- •History of invasive pneumococcal diseases or other pneumococcal diseases caused by Streptococcus pneumoniae, as confirmed by laboratory tests
- •History of allergy or adverse reactions to the vaccine or vaccine components, or history of allergy, such as urticaria, dyspnea, angioedema and anaphylactic shock
- •History of severe diseases judged by the investigator to interfere with vaccination, including but not limited to cardiovascular and cerebrovascular diseases (e.g., complicated or complex congenital heart disease), hematological diseases (e.g., severe anemia), liver and renal diseases, digestive system diseases, respiratory diseases (e.g., active pulmonary tuberculosis), malignant tumors, history of major solid organ transplantation, etc.
- •Autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection)
- •Abnormal coagulation functions (e.g., coagulation factor deficiency, blood coagulation diseases, platelet disorders)
- •Have/have suffered from a serious neurological disorder (epilepsy , convulsions or seizures) or mental illness or have a family history of such diseases
- •Have received > 14 days of corticosteroids or other immunomodulatory therapy in the past 6 months(defined as ≥2 mg/kg per day with a maximum daily dose of no less than 20 mg prednisone equivalent, or equivalent dosage), or cytotoxic therapy, or plan to receive such therapy during the study period (inhaled, intranasal or topical corticosteroids are excluded)
- •Received immunoglobulin or other blood products within 3 months prior to enrollment, or plan to receive such treatment during the study period
- •.Received other investigational drugs or vaccines within 30 days prior to enrollment, or plan to receive such drugs or vaccines during the study
- •Received live attenuated vaccine within 14 days prior to enrollment
- •Received subunit or inactivated or other vaccine within 7 days prior to enrollment
- •Acute diseases or acute onset of chronic diseases within 7 days prior to enrollment, or known or suspected active infection
- •Had fever (axillary temperature> 37.0℃) prior to administration on the scheduled study vaccination day
- •In the investigator's judgment, the participant has any other factors that make him or her unfit to participate in the clinical trial
研究组 & 干预措施
PCV13 Lot 2
375 participants aged 2-5 years will be randomized to receive Sinovac PCV13 Lot 2. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose
干预措施: Sinovac PCV13 lot 2 (Biological)
PCV13 Lot 3
375 participants aged 2-5 years will be randomized to receive Sinovac PCV13 Lot 3. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose
干预措施: Sinovac PCV13 lot 3 (Biological)
PCV13 Lot 1
375 participants aged 2-5 years will be randomized to receive Sinovac PCV13 Lot
1. Route of administration is intramuscular injection at deltoid muscle of upper arm. Immunization schedule is 1 dose
干预措施: Sinovac PCV13 lot 1 (Biological)
结局指标
主要结局
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC) 30 days after vaccination
时间窗: 30 days after vaccination
Equivalence Criterion: The 95% confidence intervals (CIs) for the ratios of serotype-specific IgG geometric mean concentrations (GMCs) between any two lots shall lie entirely within the range of 0.5 to 2.0,as measured by enzyme-linked immunosorbent assay (ELISA) method
次要结局
- Percentage of Pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate) 30 days after vaccination(30 days after vaccination)
- Percentage of Pneumococcal serotype-specific IgG antibody concentration ≥1.0 μg/ml 30 days after vaccination(30 days after vaccination)
- Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI) from pre-vaccination up to 30 days post-vaccination(Pre-vaccination up to 30 days post-vaccination)
- Incidence of adverse reactions within 7 days after vaccination(0-7 days after vaccination)
- Incidence of adverse reactions within 30 days after vaccination(0-30 days after vaccination)
- Incidence of serious adverse events (SAE) within 6 months after vaccination(0-6 months after vaccination)