A Randomized, Double-blind, Controlled Combined With Open-label Phase Ia Clinical Trial to Evaluate the Safety and Immunogenicity of 24-valent Pneumococcal Conjugate Vaccine in Children Aged 2-17 Years.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Incidence of adverse reactions
研究概览
简要总结
A Phase Ia clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2-17 years. The objective of the study is to evaluate the safety and immunogenicity of Sinovac PCV24. The trial is a randomized, double-blind, controlled combined with open-label phase Ia clinical trial.
详细描述
A phase Ia clinical trial of the study of 24-valent Pneumococcal Conjugate Vaccine (PCV24) developed by Sinovac Life Science Co., Ltd (Sinovac) will be conducted in Chinese children aged 2-17 years. The trial is a randomized, double-blind, controlled combined with open-label study. The objective of this study is to evaluate the safety and immunogenicity of PCV24 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine for participants aged 2-5 years is the Prevenar13® manufactured by Pfizer.
A total of at least 114 participants will be enrolled, including 24 children aged 6-17 years and 90 children aged 2-5 years. Children aged 6-17 years will receive PCV24 formulation 1 and PCV24 formulation 2 in a 1:1 ratio. Children aged 2-5 years will receive PCV24 formulation 1, PCV24 formulation 2 and Prevenar13® in a 1:1:1 ratio.
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)
盲法说明
Quadruple for children aged 2-5 years; open-label for children aged 6-17 years
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers who are aged 2-17 years;
- •Participants and their guardians provide legal proof of identity, as well as vaccination record (for children aged 2-5 years);
- •Participants' guardians understand and voluntarily sign the informed consent form; participants aged 8-17 years sign the written assent;
- •Participants can follow all study procedures and stay in contact during the study.
排除标准
- •Received any pneumococcal vaccine prior to enrollment;
- •History of invasive pneumococcal diseases (IPDs) 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;
- •Congenital malformations or developmental disorders, genetic defects (such as Down syndrome, thalassemia, or G6PD deficiency), severe malnutrition;
- •Have uncontrolled chronic diseases or history of severe diseases, including but not limited to cardiovascular diseases, such as cardiovascular diseases (e.g. congenital heart disease), metabolic diseases (such as diabetes), hematological diseases (e.g. severe anemia),liver and kidney diseases, digestive diseases, respiratory diseases (such as active tuberculosis), malignant tumors and major functional organ transplantation history;
- •Autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection)
- •Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets level), history of obvious bleeding, hematoma or bruising after intramuscular injection or venipuncture.
- •Have/have suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases.
- •Long-term alcohol or drug abuse.
- •Have received > 14 days of immunosuppressive or other immunomodulatory therapy in the past 6 months, or cytotoxic therapy, or plan to receive such therapy during the study period.
- •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;
- •Women who are pregnant or breastfeeding (if applicable);
- •Abnormalities in clinical laboratory indicators that exceed reference range and are clinically significant.
- •Had fever (axillary temperature> 37.0℃) before vaccination;
- •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
Experimental group 1
12 participants aged 6-17 years and 30 participants aged 2-5 years will be randomized to receive Sinovac PCV24 formulation 1. Route of administration is intramuscular injection at deltoid muscle of upper arm.
Immunization schedule is 1 dose.
干预措施: Sinovac PCV24 formulation 1 (Biological)
Experimental group 2
12 participants aged 6-17 years and 30 participants aged 2-5 years will be randomized to receive Sinovac PCV24 formulation 2. Route of administration is intramuscular injection at deltoid muscle of upper arm.
Immunization schedule is 1 dose.
干预措施: Sinovac PCV24 formulation 2 (Biological)
Active control group
30 participants aged 2-5 years will be randomized to receive Prevenar13®. Route of administration is intramuscular injection at deltoid muscle of upper arm.
Immunization schedule is 1 dose.
干预措施: Prevenar13® (Biological)
结局指标
主要结局
Incidence of adverse reactions
时间窗: 0-30 days after vaccination
Incidence of adverse reactions within 30 days after vaccination
次要结局
- Incidence of adverse reactions(0-7 days after vaccination)
- Proportion of Pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)(30 days after vaccination)
- Proportion of Pneumococcal serotype-specific IgG antibody concentration ≥1.0 μg/ml(30 days after vaccination)
- Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)(30 days after vaccination)
- Pneumococcal serotype-specific opsonophagocytic assay (OPA) geometric mean titer (GMTs)(30 days after vaccination)
- Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)(30 days after vaccination)
- Incidence of serious adverse events (SAE)(0-6 months after vaccination)
- Incidence of clinically significant abnormality in laboratory examination tests(0-3 days after vaccination)
- Proportion of Pneumococcal serotype-specific OPA GMT≥1:8(30 days after vaccination)
- Proportion of pneumococcal serotype-specific OPA antibody titer increase≥4(30 days after vaccination)
- Proportion of pneumococcal serotype-specific IgG antibody concentration increase≥4(30 days after vaccination)
- Pneumococcal serotype-specific OPA GMI(30 days after vaccination)