NCT06314867进行中（未招募）3 期
A Single Center, Randomized, Double-blind, and Intergroup Control Clinical Study to Evaluation on Lot-to-lot Consistency and Immune Persistence of Three Commercial Batches of 23 Valent Pneumococcal Polysaccharide Vaccine
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 990
- 试验地点
- 1
- 主要终点
- Geometric mean concentration (GMC) levels
研究概览
简要总结
The research objective is to evaluate lot-to-lot consistency and immune persistence of three commercial batches of 23 valent pneumococcal polysaccharide vaccine.
详细描述
This study adopted a randomized, double-blind, equivalency design with different batches of experimental vaccine. 990 individuals aged 18-59 were included and divided into three groups at a ratio of 1:1:1, with 330 individuals in each group receiving three batches of experimental vaccines, respectively. All subjects were vaccinated with 1 dose of 0.5ml, intramuscularly injected into the lateral deltoid muscle of the upper arm.
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
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged 18-59;
- •Voluntarily participate and sign an informed consent form;
- •Subjects are able to comply with the requirements of the clinical study protocol and complete the prescribed follow-up;
- •Has not received pneumococcal vaccine or any other preventive products recently (has not received attenuated live vaccine within 14 days, has not received inactivated vaccine within 7 days);
- •Underarm temperature ≤ 37.0 ℃;
- •Female participants of childbearing age agree to take effective contraceptive measures within 3 months from the start of the study until the full vaccination period.
排除标准
- •Subjects with a history or family history of progressive neurological disorders such as epilepsy, encephalopathy, and mental illness;
- •Has a history of severe allergies to any drugs or vaccines in the past;
- •Has a allergy history to any component of the experimental vaccine (the main components of the vaccine include type 23 pneumococcal polysaccharides, sodium chloride, sodium dihydrogen phosphate, and sodium dihydrogen phosphate);
- •Suffering from severe cardiovascular diseases (heart disease, pulmonary heart disease, pulmonary edema, drug-resistant hypertension (systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg)); drug-resistant diabetes;
- •Subjects with a history of thrombocytopenia or other coagulation disorders that may cause contraindications for subcutaneous injection;
- •Subjects with known immunological dysfunction or low levels, or HIV infection;
- •Any situation leading to splenomegaly, splenectomy, or functional splenomegaly;
- •Malignant tumors, active or treated tumors that have not been clearly cured, or are likely to recur during the study period;
- •Anti tuberculosis prevention or treatment is under way;
- •Subjects who are participating in or planning to participate in clinical trials of other drugs or vaccine clinical trials throughout the entire observation period;
- •Women of childbearing age are in pregnancy (positive urine pregnancy test) or lactation period;
- •Any situation that the researcher believes may affect the evaluation of the study.
结局指标
主要结局
Geometric mean concentration (GMC) levels
时间窗: 30 days after immunization
Geometric mean concentration (GMC) levels of 23 serotype specific IgG antibodies
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and AboveRespiratory Syncytial Virus InfectionsNCT05059301GlaxoSmithKline770
已完成
3 期
Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio VaccinePoliomyelitisNCT04386707Sinovac Biotech Co., Ltd1,300
已完成
3 期
Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in AdultsOrthomyxoviridae InfectionMyxovirus InfectionInfluenzaNCT00772109Sanofi Pasteur, a Sanofi Company4,292
进行中（未招募）
3 期
A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, AdsorbedDiphtheriaWhooping CoughTetanusNCT05091619China National Biotec Group Company Limited2,898
已完成
3 期
Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in AdultsOrthomyxoviridae InfectionMyxovirus InfectionInfluenzaNCT00383539Sanofi Pasteur, a Sanofi Company2,256