Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (Multivalent Conjugate) in Infants Aged 2 Months (at Least 6 Weeks) and 3 Months
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,800
- 试验地点
- 5
- 主要终点
- 13 vaccine serotype-specific pneumococcal IgG antibodies GMC
研究概览
简要总结
This study is a phase III clinical trial to evaluate the immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (multivalent conjugate) in infants aged 2 months (at least 6 weeks) and 3 months. The main objectives of the study include: 1. To evaluate the immunogenicity of the trial vaccine in infants aged 2 months (at least 6 weeks) following the corresponding immunization schedule compared to the control vaccine; 2. To evaluate the immunogenicity of the trial vaccine in infants aged 3 months following the corresponding immunization schedule compared to the 2-month group; 3. To evaluate the safety of the trial vaccine in infants aged 2 months (at least 6 weeks) and 3 months following the corresponding immunization schedule.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Weeks 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary immunization phase:
- •The subject's legal guardian voluntarily agreed to allow his child to participate in the study and signed an informed consent form.
- •The subject's legal guardian has the ability to understand the study procedures and to participate in all planned follow-up visits.
- •Full-term pregnancy (37 weeks to 42 weeks gestation) and the birth weight was 2500g~4000g.
- •On the day of the first dose of vaccination, it meets the observation age of this clinical trial (2~3 months of age, with a minimum of 6 weeks) and be able to provide legal identification;
- •Not having received a non-live vaccine within 7 days prior to enrollment and not having received a live vaccine within 14 days;
- •The body temperature <37.5°C (axillary body temperature) on the day of enrollment.
- •Booster immunization phase:
- •Infants and children who have completed the full process of basic immunization in this clinical trial and are 12 to 15 months of age;
- •According to the opinion of the investigator, the subject's legal guardians and their families can comply with the requirements of the clinical trial protocol.
排除标准
- •Primary immunization phase:
- •The baby is born in abnormal labor (dystocia, instrumental delivery) or has a history of asphyxia and nervous system damage, and is now suffering from pathologic jaundice, perianal abscess and severe eczema;
- •Have been vaccinated against pneumococcus in the past or have a history of invasive diseases caused by pneumococcus in the past (confirmed by either clinical, serological or microbiological methods);
- •Previous history of severe allergy to any vaccine or drug, such as anaphylactic shock, allergic laryngeal edema, allergic purpura and local allergic necrosis reaction (Arthus reaction);
- •Suffering from congenital or acquired immunodeficiency, or receiving immunosuppressant treatment, such as systemic glucocorticoid treatment for more than 2 weeks one month before vaccination, such as prednisone or similar drugs > 5mg/day (use of local and inhaled/atomized steroids is eligible for enrollment);
- •Have received blood or blood-related products or immunoglobulin treatment before joining the group (hepatitis B immunoglobulin is acceptable);
- •Suffering from severe congenital malformation, severe developmental disorders, serious genetic diseases (such as severe thalassemia), severe malnutrition, etc.;
- •Suffering from infectious diseases such as tuberculosis and viral hepatitis, or parents infected with human immunodeficiency virus;
- •Having contraindications to intramuscular injections such as thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy;
- •Those with a history or family history of convulsions, epilepsy, encephalopathy and psychosis;
- •Asplenia, functional asplenia, and asplenia or splenectomy for any reason;
- •Subjects with other safety risks or conditions that, in the opinion of the investigator, may interfere with the assessment of the purpose of the study.
- •Booster immunization phase:
- •Subject received any other pneumonia vaccine after primary immunization and before booster immunization;
- •Subject has received blood or blood-related products or immunoglobulin treatment within 3 months before booster immunization;
- •The subjects have known or suspected immunological functional defects since they participated in this clinical trial, including receiving immunosuppressant treatment (such as systemic glucocorticoid treatment for more than 2 weeks in one month before vaccination, such as prednisone or similar drugs > 5mg/day) and their parents are HIV-infected;
- •According to the researcher's judgment, the subjects have any other factors that are not suitable for clinical trials.
研究组 & 干预措施
2-month-old experimental group
Vaccination of 4 doses of experimental vaccine(0,2,4,1 booster dose)
干预措施: 13-valent pneumococcal conjugate vaccine (multivalent conjugate) (Biological)
2-month-old control group
Vaccination of 4 doses of control vaccine(0,2,4,1 booster dose)
干预措施: Prevenar 13 (Biological)
3-month-old group
Vaccination of 4 doses of experimental vaccine(0,1,2,1 booster dose)
干预措施: 13-valent pneumococcal conjugate vaccine (multivalent conjugate) (Biological)
结局指标
主要结局
13 vaccine serotype-specific pneumococcal IgG antibodies GMC
时间窗: 30 days after primary immunization
Immunogenicity
incidence of adverse events (AE)
时间窗: 30 minutes/0~7 days/0~30 days after each dose of vaccination
Safety
incidence of all serious adverse events (SAEs)
时间窗: from the first dose of vaccination to 12 months after the booster immunization
Safety
seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies
时间窗: 30 days after primary immunization
Immunogenicity
次要结局
- the positivity rate of pneumococcal OPA antibodies for 13 vaccine serotypes(30 days after booster immunization)
- percentage of subjects with 13 vaccine serotype-specific pneumococcal IgG antibody concentrations ≥1.0 μg/ml(30 days after primary immunization)
- GMC of 13 vaccine serotype-specific pneumococcal IgG antibodies(30 days after booster immunization)
- the GMT of pneumococcal OPA antibodies for 13 vaccine serotypes(30 days after booster immunization)
- the seroconversion rate of pneumococcal OPA antibodies for 13 vaccine serotypes(30 days after primary immunization)
- seroprotection rate of 13 vaccine serotype-specific pneumococcal IgG antibodies(30 days after booster immunization)
- percentage of subjects with 13 vaccine serotype-specific pneumococcal IgG antibody concentrations ≥ 1.0 μg/mL(30 days after booster immunization)