NCT06044077招募中3 期
A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People Aged 2 Years and Above
Aimei Vacin BioPharm (Zhejiang) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 1,920 人开始时间: 2023年9月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,920
- 试验地点
- 1
- 主要终点
- 2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,
研究概览
简要总结
This study is a randomized, blinded, parallel controlled phase 3 clinical trial to evaluate the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in healthy people aged 2 years and above.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects who meet the observation age of this clinical trial (2 years old and above) and are determined based on medical history, physical examination and the researcher's judgment;
- •Subjects who voluntarily participate and/or the subjects' legal guardians Or the entrusted person voluntarily agrees for his or her child to participate and signs an informed consent form (subjects aged 8-17 years old must also sign an informed notification form);
- •The subject and/or the subject's legal guardian or principal can abide by the clinical Relevant requirements of the research protocol;
- •*Axillary body temperature <37.3°C on the day of enrollment. For criteria marked with an asterisk (*), if the subject has the conditions specified in the criterion, the visit can be rescheduled when they no longer have those conditions.
排除标准
- •Previous vaccination with marketed or experimental pneumococcal vaccines;
- •Previous culture-confirmed history of invasive diseases caused by pneumococcal bacteria;
- •History or family history of convulsions, epilepsy, encephalopathy, and mental illness;
- •Have a history of severe allergy to any vaccination or drug in the past, be allergic to the ingredients of the experimental vaccine (mainly including pneumococcal polysaccharide, sodium dihydrogen phosphate, disodium hydrogen phosphate, and sodium chloride), and have a history of vaccination-related fever (39℃ or above );
- •Known severe congenital malformations, developmental disabilities or clinically diagnosed serious chronic diseases (such as Down syndrome, diabetes that cannot be controlled by drugs, sickle cell anemia, Guillain-Barré syndrome);
- •Known or suspected to have serious diseases including: severe respiratory diseases, severe digestive system diseases, severe endocrine system diseases, severe cardiovascular diseases, severe liver and kidney diseases, malignant tumors, severe skin diseases, etc.;
- •Known or suspected to be immune Academic functional defects include: immunosuppressant treatment (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc. within 6 months;
- •Have received any treatment within 3 months before enrollment Blood products or globulin treatment, those who have used hepatitis B immune globulin are acceptable;
- •Asplenia, functional asplenia or splenectomy;
- •* In the acute infectious period (including recovery period) or acute exacerbation of chronic disease within 3 days before enrollment, or need or plan to use intravenous or oral steroids within 1 month after vaccination;
- •* Antipyretic analgesics or anti-allergic drugs have been used within 3 days before enrollment;
- •Women of childbearing age are pregnant ( Positive urine pregnancy test), breastfeeding or planning to prepare for pregnancy within six months;
- •*Hypertension that cannot be controlled by medication, such as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg in adults aged 18 years and above before enrollment;
- •* Have received attenuated live vaccines within 14 days before vaccination, and received inactivated vaccines within 7 days;
- •Are participating in or plan to participate in clinical studies of other drugs or vaccines within 6 months after vaccination (immune persistence observation subjects in the vaccine who plan to vaccinate any marketed or unmarketed pneumococcal vaccine within 6 years after vaccination need to be excluded);
- •The investigators evaluate that they are not suitable for participating in the study.
- •For criteria marked with an asterisk (*), if the subject has the conditions specified in the criterion, the visit can be rescheduled when they no longer have those conditions.
结局指标
主要结局
2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,
时间窗: 30 days
2-fold growth rate of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination,
Incidence of adverse reactions/events on days 0 to 7 after vaccination
时间窗: 7 days
Incidence of adverse reactions/events on days 0 to 7 after vaccination
Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination
时间窗: 30 days
Geometric mean concentration (GMC) of IgG antibodies to 23 pneumococcal serotypes on 30 days after vaccination
Incidence of adverse reactions/events within 30 minutes of vaccination
时间窗: 30 min after vaccination
Incidence of adverse reactions/events within 30 minutes of vaccination
Incidence of adverse reaction/event on days 0 to 30 after vaccination
时间窗: 30 days
Incidence of adverse reaction/event on days 0 to 30 after vaccination
Incidence of serious adverse events (SAE) within 6 months after vaccination
时间窗: 6 months
Incidence of serious adverse events (SAE) within 6 months after vaccination
次要结局
- GMC of 23 pneumococcal serotype IgG antibodies in the 3rd and 6th year after vaccination(3, 6 years after vaccination)
- Geometric mean fold increase (GMFI) of IgG antibodies against 23 pneumococcal serotypes 30 days after vaccination(30 days)
研究者
研究点 (1)
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