A Single-center, Randomized, Double-blind, Active-controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of 26-valent Pneumococcal Conjugate Vaccine in People Aged 2 Months and Older
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ）
研究概览
简要总结
The purpose of this experiment is to evaluate the safety and immunogenicity of the 26 valent pneumococcal conjugate vaccine in the population aged 2 months and above.
详细描述
A single-center, randomized, double-blind, active-controlled trial design (Phase I/II) was used. In addition, according to the requirements in the approval letter of this product (2024LP01053), serum standards need to be established for the newly added types (24F, 35B). Therefore, a calibration group is set and an open study design is adopted.
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 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is 2-3 months old (minimum 6 weeks old), 7 months old and above at the time of enrollment, and the legal guardian and/or the subject can provide legal identification certificate;
- •The subjects themselves and/or their legal guardians understand the vaccination and trial procedures, voluntarily participate in the trial and sign the informed consent form;
- •The subject and/or legal guardian can comply with the clinical trial protocol, have the ability to use thermometer, scale and fill in diary card and contact card as required;
- •Female subjects of childbearing potential agree to take effective contraceptive measures from enrollment to 6 months after vaccination.
- •For calibration group subjects: 18 to 55 years of age, ≥ 50 kg for males or ≥ 45 kg for females.
排除标准
- •Axillary body temperature ≥ 37.3 ℃ on the day of enrollment;
- •History of infectious diseases caused by Streptococcus pneumoniae confirmed by bacterial culture within 3 years;
- •Have received or plan to receive a Streptococcus pneumoniae vaccine outside the trial protocol, including marketed or other investigational Streptococcus pneumoniae vaccines;
- •Pregnant or lactating women; Previous history of severe allergy to any vaccine or drug, such as urticaria, dyspnea, angioneurotic edema, anaphylactic shock, Henoch-Schonlein purpura, thrombocytopenic purpura;
- •Allergic to any component of the investigational vaccine;
- •Suffering from severe respiratory diseases (such as severe asthma), heart diseases, liver diseases, kidney diseases, congenital malformations, developmental disorders and genetic defects (including but not limited to: down syndrome, thalassemia major, etc.) that may interfere with the conduct or completion of the trial;
- •Diagnosed with congenital or acquired immunodeficiency, or suspected to have serious chronic disease or systemic disease that may interfere with the conduct or completion of the trial, such as: active tuberculosis, human immunodeficiency virus (HIV) infection, etc.;
- •Encephalopathy, uncontrolled epilepsy, convulsion and other progressive neurological diseases, or a history or family history of mental illness;
- •Contraindications for intramuscular injection such as thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy;
- •Asplenia or splenectomy, functional asplenia due to any condition;
- •Immunosuppressant therapy, cytotoxic therapy or corticosteroid therapy within 3 months prior to vaccination, such as systemic glucocorticoid therapy for more than 2 consecutive weeks, such as prednisone or similar drugs > 5 mg/day (excluding corticosteroid spray therapy for allergic rhinitis, surface corticosteroid therapy for acute non-complicated dermatitis);
- •Received blood products or immunoglobulins within 3 months prior to enrollment (hepatitis B immunoglobulin is acceptable), or planned to be used during the trial (before the last immunogenicity blood sample collection);
- •Within 3 days before the first dose of vaccine, the patient has acute illness or is in acute attack of chronic disease, or has used antipyretic, analgesic or anti-allergic drugs (such as: acetaminophen, ibuprofen, aspirin, etc.);
- •Received non-live vaccine within 7 days (≤ 7 days) or live attenuated vaccine within 14 days (≤ 14 days) prior to enrollment;
- •Hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg, applicable to adults);
- •Abnormal and clinically significant laboratory test results, which are not suitable for enrollment as determined by the investigator (applicable to subjects aged 2 years and older in Phase I);
- •Birth weight < 2.5 kg, premature delivery (gestational age < 37 weeks), history of abnormal labor process, history of asphyxia rescue, history of nerve organ damage, history of pathological jaundice confirmed by diagnosis;
- •For Standardised Subjects:
- •① Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 50 U/L; Or hemoglobin ≤ 115 g/L (female)/120g/L (male); Any positive serology for hepatitis B, hepatitis C, HIV, or syphilis.
- •Plans to move before the end of the trial or leave the area for an extended period of time during scheduled trial visits;
- •Ongoing participation or planning to participate in other clinical trials (vaccines, drugs, medical devices, etc.) in the near future;
- •Subject has any condition that, in the opinion of the investigator, may interfere with the evaluation of the objectives of the trial.
研究组 & 干预措施
≥60 years old age group (for phase Ⅰ)
There are 30 subjects in ≥60 years old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.
干预措施: 26-Valent pneumococcal conjugate vaccine (Biological)
≥60 years old age group (for phase Ⅰ)
There are 30 subjects in ≥60 years old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.
干预措施: 23-Valent pneumococcal polysaccharide vaccine (Biological)
18-59 years old age group (for phase Ⅰ)
There are total 40 subjects in 18-59 age group. Among them, 30 subjects were randomly assigned to the experimental group and the control group in a 2:1 ratio. In addition, other 10 subjects aged 18-55 to receive the experimental vaccine as the serum calibration test population.
干预措施: 26-Valent pneumococcal conjugate vaccine (Biological)
18-59 years old age group (for phase Ⅰ)
There are total 40 subjects in 18-59 age group. Among them, 30 subjects were randomly assigned to the experimental group and the control group in a 2:1 ratio. In addition, other 10 subjects aged 18-55 to receive the experimental vaccine as the serum calibration test population.
干预措施: 23-Valent pneumococcal polysaccharide vaccine (Biological)
6-17 years old age group (for phase Ⅰ)
There are 30 subjects in 6-17 years old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.
干预措施: 26-Valent pneumococcal conjugate vaccine (Biological)
6-17 years old age group (for phase Ⅰ)
There are 30 subjects in 6-17 years old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.
干预措施: 23-Valent pneumococcal polysaccharide vaccine (Biological)
2-5 years old age group (for phase Ⅰ/Ⅱ)
There are total 230 people in 2-5 years old age group. Among them, there were 30 subjects included in the phase Ⅰ clinical trial and were randomly assigned to the experimental group and the control group in a 2:1 ratio. And the other 200 people were included for phase Ⅱ and were randomly assigned to the experimental group and the control group in a 1:1 ratio.
干预措施: 26-Valent pneumococcal conjugate vaccine (Biological)
2-5 years old age group (for phase Ⅰ/Ⅱ)
There are total 230 people in 2-5 years old age group. Among them, there were 30 subjects included in the phase Ⅰ clinical trial and were randomly assigned to the experimental group and the control group in a 2:1 ratio. And the other 200 people were included for phase Ⅱ and were randomly assigned to the experimental group and the control group in a 1:1 ratio.
干预措施: 13-Valent pneumococcal conjugate vaccine (Biological)
13-23 months old age group (for phase Ⅰ)
There are 30 subjects in 13-23 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.
干预措施: 26-Valent pneumococcal conjugate vaccine (Biological)
13-23 months old age group (for phase Ⅰ)
There are 30 subjects in 13-23 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.
干预措施: 13-Valent pneumococcal conjugate vaccine (Biological)
7-11 months old age group (for phase Ⅰ)
There are 30 subjects in 7-11 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.
干预措施: 26-Valent pneumococcal conjugate vaccine (Biological)
7-11 months old age group (for phase Ⅰ)
There are 30 subjects in 7-11 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.
干预措施: 13-Valent pneumococcal conjugate vaccine (Biological)
3 months old age group (for phase Ⅰ)
There are 30 subjects in 3 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.
干预措施: 26-Valent pneumococcal conjugate vaccine (Biological)
3 months old age group (for phase Ⅰ)
There are 30 subjects in 3 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.
干预措施: 13-Valent pneumococcal conjugate vaccine (Biological)
2 months old age group （for phase Ⅰ）
There are 30 subjects in 2 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.
干预措施: 26-Valent pneumococcal conjugate vaccine (Biological)
2 months old age group （for phase Ⅰ）
There are 30 subjects in 2 months old age group, randomly assigned to the experimental group and the control group in a 2:1 ratio.
干预措施: 13-Valent pneumococcal conjugate vaccine (Biological)
结局指标
主要结局
AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ）
时间窗: 30 day after each vaccination
All AE occurrences within 0-30 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination)
Solicited AE occurrences within 0-30 minutes after each dose of vaccination (for phase Ⅰ/Ⅱ）
时间窗: 30 minutes after each vaccination
The occurrence of Solicited adverse events (AE) within 0-30 minutes after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination)
Solicited AE occurrences within 0-7 days after each dose of vaccination (for phase Ⅰ/Ⅱ）
时间窗: 0-7 days after each vaccination
The occurrence of solicited adverse events (AE) within 0-7 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination);
Unsolicited AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ）
时间窗: 0-30 days after each vaccination
The occurrence of unsolicited adverse events (AE) within 0-30 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination);
Grade 3 and above AE occurrences within 0-30 days after each dose of vaccination (for phase Ⅰ/Ⅱ）
时间窗: 0-30 days after each vaccination
The occurrence of grade 3 and above adverse events within 0-30 days after each dose of vaccination (number of cases, incidence rate, and relationship with vaccination).
All SAE occurrences within 0-6 months after vaccination (for Phase Ⅱ)
时间窗: 0-6 months after each vaccination
The occurrence of all serious adverse reactions within 6 months after vaccination (number of cases, incidence rate, and relationship with vaccination)
Positive rate of serotype-specific pneumococcal IgG antibody on the 30th day after immunization in subjects aged 2-5 years （for phase Ⅱ）
时间窗: 30 day after vaccination
Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 μg/ml on Day 30 after vaccination in subjects aged 2-5 years
次要结局
- All SAE in the population aged ≥12 months during 0-6 months after vaccination （for phase Ⅰ）(0-6 months after vaccination)
- All SAE in the population aged <12 months from the first dose to 6 months after the primary immunization and from the booster to 6 months after the booster（for phase Ⅰ）(From the first dose to 6 months after the primary immunization and from the booster to 6 months after the booster)
- Proportion of IgG antibodies ≥ 1.0 µg/mL and GMC results on Day 30 post-immunization（for phase Ⅱ）(30 day after vaccination)