A Phase Ⅲ Clinical Study to Evaluate the Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Healthy Infants
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 3,080
- 试验地点
- 1
- 主要终点
- Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)
研究概览
简要总结
A Phase Ⅲ clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 6 weeks)-5 years (before 6th birthday). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13.
详细描述
A phase Ⅲ 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 pediatric population aged 2 months (minimum 6 weeks)-5 years (before the 6th birthday). The trial is a randomized, double-blind, active controlled study. The objective of this study is to evaluate the immunogenicity and safety of PCV13 manufactured by Sinovac Life Science Co., Ltd. The active control vaccine is Prevenar13®. A total of at least 3080 participants aged 6 weeks to 5 years will be enrolled. Participants will be randomized in 1:1 ratio to the test group or control group.
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
- 6 Weeks 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants or children who are aged 2 months (at least 6 weeks), 7-11 months, 12-23 months and 2-5 years (before the 6th birthday);
- •Participants' guardians provide legal identity document and participants' vaccination record;
- •Participants' guardians understand and voluntarily sign the informed consent form;
- •Participants' guardians 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 bacterial pneumonia or invasive pneumococcal diseases (IPDs) 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 abdominal pain;
- •History of dystocia, asphyxia rescue and nervous system damage at birth for infants under 2 years of age;
- •Congenital malformations or developmental disorders, genetic defects, severe malnutrition, history of asthma;
- •Autoimmune diseases (such as systemic lupus erythematosus), immunodeficiency diseases or immunosuppressive diseases (such as AIDS, organ transplantation);
- •Severe cardiovascular diseases, diabetes, liver diseases, kidney diseases, malignant tumours.
- •Have/have suffered from a serious neurological disorder (epilepsy or convulsions) or mental illness or have a family history of such diseases.
- •History of thyroidectomy, asplenia, functional asplenia; asplenia or splenectomy caused by any reasons;
- •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.
- •Consecutively received ≥14 days of corticosteroid, any other immunosuppressive therapy (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-concurrent dermatitis), or cytotoxic therapy prior to enrollment for infants aged 6 weeks to 2 months or within 6 months prior to enrollment for children aged 7 months to 5 years.
- •Received blood products prior to enrollment for children aged 2 months or within 3 months prior to enrollment for children aged 7 months to 5 years. Receipt of Hepatitis B immunoglobulin one month prior to enrollment is an exception.
- •Received other investigational drugs within 60 days prior to enrollment, or plan to receive such drugs 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;
- •Had fever (axillary temperature≥ 37.3 Degree Celsius) 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: Sinovac PCV13
Participants aged 6 weeks-5 years will receive 4 doses of Sinovac PCV13 according to different immunization schedules.
干预措施: Sinovac PCV13 (Biological)
Active Comparator: Prevnar®
Participants aged 6 weeks-5 years will receive 4 doses of Prevnar 13® according to different immunization schedules.
干预措施: Prevnar® (Biological)
结局指标
主要结局
Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)
时间窗: 30 days after primary vaccination
Proportion of serotype-specific IgG concentration ≥0.35 μg/ml
Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)
时间窗: 30 days after primary vaccination
IgG GMC
次要结局
- Proportion of pneumococcal serotype-specific IgG antibody concentration ≥0.35 μg/ml (seropositive rate)(30 days after booster vaccination)
- Pneumococcal serotype-specific IgG antibody geometric mean concentration (GMC)(30 days after booster vaccination)
- Proportion of pneumococcal serotype-specific OPA antibody GMT≥1:8(30 days after primary vaccination)
- Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)(30 days after booster vaccination)
- Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL(30 days after booster vaccination)
- Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)(30 days after booster vaccination)
- Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI)(30 days after booster vaccination)
- Proportion of participants with pneumococcal serotype-specific OPA titers ≥ 1:8 (seropositive rate)(30 days after booster vaccination)
- Safety of Sinovac PCV13(6 months within final dose)
- Pneumococcal serotype-specific OPA antibody geometric mean titer (GMT)(30 days after primary vaccination)
- Proportion of participants with a pneumococcal serotype-specific IgG concentration ≥ 1.0 μg/mL(30 days after primary vaccination)
- Pneumococcal serotype-specific IgG antibody geometric mean increase (GMI)(30 days after primary vaccination)
- Pneumococcal serotype-specific OPA antibody geometric mean increase(GMI)(30 days after primary vaccination)
- Safety of Sinovac PCV13(0-30 days within each dose)