NCT06838195尚未招募3 期
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Protective Efficacy, Immunogenicity, and Safety of the S. Flexneri-S. Sonnei Bivalent Conjugate Vaccine in Infants and Children Aged 6 Months to 5 Years in Bangladesh
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- The protective efficacy of S. Flexneri-S. Sonnei bivalent conjugate vaccine
研究概览
简要总结
The goal of this clinical trial is to evaluate the protective efficacy of S. Flexneri-S. Sonnei bivalent conjugate vaccine against diarrhea caused by Shigella infection in infants and children aged 6 months to 5 years. Researchers will observe the incidence of diarrhea of any severity due to Shigella flexneri and Shigella sonnei infection 30 days after full immunization. The subjects will receive 2 doses of vaccination.
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 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants and children aged 6 months to 5 years.
- •Legal guardians voluntarily agree to participate in the study and sign an informed consent form.
- •Legal guardians agree to comply with the requirements of the clinical trial protocol and are willing and able to participate in all planned follow-ups.
- •The subject's guardian agrees that the subject should not abuse antibiotics. If needed，antibiotics should be used under the guidance of a doctor and avoid taking antibiotics on their own during the clinical trial.
- •Based on medical history, physical examination, and the investigator's judgment, the subject is determined to be in good health.
排除标准
- •History of confirmed bacterial dysentery in the past 6 months.
- •Serious allergy to tetanus toxoid, history of severe allergies, fever above 39.5°C following previous vaccination with a prophylactic biological product.
- •Currently suffering from serious intestinal diseases, symptoms of diarrhea, abdominal pain, or bloody purulent stools in the past 15 days.
- •Diagnosed pathological jaundice currently.
- •Confirmed diagnosis of thrombocytopenia or other coagulation disorders.
- •Known or suspected immunological deficiencies (e.g., perianal abscesses indicating potential immune deficiency in infants and young children), long-term treatment (≥14 days) with immunosuppressants within half a year before vaccination (radiotherapy, chemotherapy, systemic corticosteroids ≥2 mg/kg/day, antimetabolites, cytotoxic drugs), or parents confirmed to have HIV infection.
- •Receipt of immunoglobulins/blood products (except hepatitis B immunoglobulin) within 3 months before vaccination.
- •Severe congenital anomalies (important organ function impairment), severe malnutrition, developmental disorders, severe hereditary diseases.
- •Currently suffering from the following diseases:
- •Severe liver or kidney diseases, cardiovascular diseases, malignant tumors, and other severe chronic diseases.
- •Diagnosed serious infectious diseases, such as tuberculosis, viral hepatitis, etc.
- •Severe asthma.
- •Generalized rashes, dermatophytosis, skin suppuration, or blistering.
- •Convulsions, epilepsy, encephalopathy, psychiatric disorders or family history of psychiatric disorders.
- •Planning to participate or currently participating in other vaccine or drug clinical trials.
- •Any condition that the investigators believe may affect the evaluation of the study.
研究组 & 干预措施
Vaccine group
Experimental
4000 subjects aged 6 months to 5 years are enrolled in this group.
干预措施: S. Flexneri-S. Sonnei bivalent conjugate vaccine (Biological)
Placebo group
Placebo Comparator
4000 subjects aged 6 months to 5 years are enrolled in this group.
干预措施: Placebo (Biological)
结局指标
主要结局
The protective efficacy of S. Flexneri-S. Sonnei bivalent conjugate vaccine
时间窗: From day 30 post full immunization to the subsequent 24-month period.
The efficacy will be assessed by comparing the incidence rate of laboratory-confirmed S. flexneri-associated or S. sonnei-associated diarrhea between the vaccinated group and the placebo group. Statistical Analysis: Protective efficacy(%)=(control group incidence (person-year incidence)- vaccine group incidence (person -year incidence))/control group incidence (person-year incidence)x100%
次要结局
- The protective efficacy against diarrhea cases with positive bacterial culture for Shigella species(From he first dose of immunization to 24-month period post full immunization.)
- Positive PCR testing for Shigella species(From day 30 post full immunization to the subsequent 24-month period.)
- IgG antibody seroconversion (fourfold increase) rate on day 30 post full immunization for subgroup 1.(The 30th day after two doses of the vaccine.)
- IgG antibody concentration on day 30 post full immunization for subgroup 1.(The 30th day after two doses of the vaccine.)
- IgG antibody seroconversion (fourfold increase) rate on day 30 post full immunization for subgroup 2.(From 30 day to 1 year after the first immunization.)
- IgG antibody concentration on day 30 post full immunization for subgroup 2.(From 30 day to 1 year after the first immunization.)
- AEs within 0-30 minutes after vaccination(Within 30 minutes after each dose of vaccine)
- Solicited AEs within 0-7 days after vaccination(Within 0-7 days after each vaccine dose.)
- Unsolicited AEs within 0-30 days after vaccination(Within 0-30 days after each vaccination)
- SAE within 0-6 months after primary immunization(Within 0-6 months after primary immunization.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 811 in Subjects With PsoriasisPsoriasisNCT01510951Amgen9
Unknown
3 期
Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 YearsShigellosisDysenteryNCT05156528Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd21,000
已完成
2 期
Phase II Study of STA-2 in Patients With Chronic Stable AnginaChronic Stable AnginaNCT01484912Sinphar Pharmaceutical Co., Ltd79
已完成
2 期
A Study Evaluating the Safety and Efficacy of a Second Course of TPX-100 in Subjects Who Previously Received TPX-100 for Patellar Osteoarthritis Involving Both KneesKnee OsteoarthritisNCT02837900OrthoTrophix, Inc14
已完成
2 期
Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative IleusIleusNCT05056935Newsoara Biopharma Co., Ltd.131