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क्लिनिकल ट्रायल NCT06314880 के लिए स्वस्थ स्वयंसेवक वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Safety, Tolerability, and Immunogenicity of Recombinant Meningococcal Group B Vaccine (E.Coli)
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'परीक्षण समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल परीक्षण NCT06314880 का मुख्य उद्देश्य रोकथाम का अध्ययन करना है। यह चिकित्सकीय अध्ययन स्वस्थ स्वयंसेवक से जुड़ा हुआ है और यह एक चरण I हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 22 जुलाई 2023 को हुई थी, और इसमें कुल 300 प्रतिभागियों के नामांकन की योजना है। Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd इस परीक्षण का नेतृत्व कर रहे हैं और इसके 30 दिसंबर 2024 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 3 अप्रैल 2024 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
The research objective is to evaluate the safety and tolerability of the recombinant Group B meningococcal vaccine (E. coli) and explore its preliminary immunogenicity.
विस्तृत विवरण
This is a Phase I, single center, randomized, double-blind, placebo-controlled clinical trial conducted in Guangxi Province, China. The purpose of this study is to evaluate the safety and tolerability of the recombinant Group B meningococcal vaccine (E. coli) and explore its preliminary immunogenicity. Expected to include 300 subjects, divide them into 5 age groups of 18-50 years old, 6-17 years old, 2-5 years old, 6-23 months old, and 3-5 months old, and 2 dose groups, a total of 10 groups, with 30 people in each group. The experimental group and placebo control group are 20 people and 10 people, respectively.
आधिकारिक शीर्षक
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluation the Safety, Tolerability, and Immunogenicity of Recombinant Meningococcal Group B Vaccine (E.Coli) in a Population Aged 3 Months-50 Years Old
चिकित्सीय स्थितियाँ
स्वस्थ स्वयंसेवकअन्य अध्ययन आईडी
- 2022112701
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2023-07-22
अंतिम अद्यतन प्रकाशित
2024-04-03
अध्ययन की समाप्ति तिथि (अनुमानित)
2024-12-30
नामांकन (अनुमानित)
300
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण I
स्थिति
भर्ती जारी
प्रमुख शब्द
Recombinant Meningococcal Group B Vaccine (E. Coli)
प्राथमिक उद्देश्य
निवारण (रोकथाम)
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
चौहरा अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/हाथ | हस्तक्षेप/इलाज |
|---|---|
प्रयोगात्मक18-50 years old 60 people per age group. The first 15 subjects in the 18-50 age group will serve as sentinels, with 10 in the experimental group and 5 in the control group. | Recombinant Meningococcal Group B Vaccine (E. Coli) (Low-dose) Each dose contains 60μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group. Recombinant Meningococcal Group B Vaccine (E. Coli) (Hign-dose) Each dose contains 100μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group. प्लेसबो नियंत्रण Placebo control. 20 people/group. |
प्रयोगात्मक6-17 years old 60 people per age group. Divided into high-dose group, low-dose group, and placebo group. | Recombinant Meningococcal Group B Vaccine (E. Coli) (Low-dose) Each dose contains 60μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group. Recombinant Meningococcal Group B Vaccine (E. Coli) (Hign-dose) Each dose contains 100μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group. प्लेसबो नियंत्रण Placebo control. 20 people/group. |
प्रयोगात्मक2-5 years old 60 people per age group. Divided into high-dose group, low-dose group, and placebo group. | Recombinant Meningococcal Group B Vaccine (E. Coli) (Low-dose) Each dose contains 60μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group. Recombinant Meningococcal Group B Vaccine (E. Coli) (Hign-dose) Each dose contains 100μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group. प्लेसबो नियंत्रण Placebo control. 20 people/group. |
प्रयोगात्मक6-23 months old 60 people per age group. Divided into high-dose group, low-dose group, and placebo group. | Recombinant Meningococcal Group B Vaccine (E. Coli) (Low-dose) Each dose contains 60μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group. Recombinant Meningococcal Group B Vaccine (E. Coli) (Hign-dose) Each dose contains 100μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group. प्लेसबो नियंत्रण Placebo control. 20 people/group. |
प्रयोगात्मक3-5 months old 60 people per age group. Divided into high-dose group, low-dose group, and placebo group. | Recombinant Meningococcal Group B Vaccine (E. Coli) (Low-dose) Each dose contains 60μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group. Recombinant Meningococcal Group B Vaccine (E. Coli) (Hign-dose) Each dose contains 100μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group. प्लेसबो नियंत्रण Placebo control. 20 people/group. |
प्राथमिक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
The incidence rate of all AEs within 0-30 days after each dose of vaccination | All AEs occurrence within 0-30 days after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination) | within 0-30 days after vaccination |
The incidence rate of solicited AEs within 30 minutes after each dose of vaccination | All solicited AEs occurrence within 30 minutes after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination) | within 30 minutes after vaccination |
The incidence rate of solicited AEs within 0-14 days after each dose of vaccination | All solicited AEs occurrence within 0-14 days after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination) | within 0-14 days vaccination |
The incidence rate of unsolicited AEs within 0-30 days after each dose of vaccination | All unsolicited AEs occurrence within 0-30 days after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination) | within 0-30 days vaccination |
The incidence rate of grade 3 and higher AEs within 0-30 days after each dose of vaccination | All grade 3 and higher AEs occurrence within 0-30 days after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination) | within 0-30 days vaccination |
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
बच्चा, वयस्क
अध्ययन के लिए न्यूनतम आयु
3 Months
अध्ययन के लिए पात्र लिंग
सभी
स्वस्थ स्वयंसेवकों को स्वीकार करता है
हाँ
- Age range from 3 months to 50 years old, legal guardian and/or individual can provide legal identification;
- The subjects and/or their legal guardians have the ability to understand the research procedures, agree to participate in the study (and/or their legal guardians agree to the child's participation in the study), and sign an informed consent form;
- The subjects and/or their legal guardians are able to participate in all planned follow-up visits;
- On the day of enrollment, the axillary temperature was less than 37.3 ℃;
- Standards for certain groups of people:
- Subjects ≥ 2 years old: laboratory test indicators (as specified in the protocol) within the normal range, or those with abnormalities but no clinical significance (evaluated by clinical doctors);
- Female participants of childbearing age: Agree to take effective contraceptive measures within 6 months from enrollment to full vaccination.
- Have received any Group B meningococcal vaccine in the past;
- A history of invasive diseases caused by meningococcus or gonococci;
- Pregnant or lactating women;
- Have any history of severe allergies to vaccines or drugs in the past, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura;
- Suffering from serious heart disease, liver disease, kidney disease, congenital malformations, developmental disorders, and genetic defects (including but not limited to Down syndrome, moderate to severe thalassemia, etc.) that may interfere with the progress or completion of the study;
- Diagnosed as having congenital or acquired immunodeficiency, or suspected of having serious chronic or systemic diseases that may interfere with the conduct or completion of the study, such as active tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV), syphilis infection, etc;
- Individuals with encephalopathy, uncontrolled epilepsy, seizures, and other progressive neurological disorders, or a history or family history of mental illness;
- Suffering from contraindications for intramuscular injection such as thrombocytopenia, any coagulation disorders, or receiving anticoagulant therapy;
- Received immunosuppressive therapy within 3 months prior to vaccination, such as continuous use of systemic glucocorticoid therapy for more than 2 weeks, such as prednisone or similar drugs>5mg/day (note: local and inhaled/nebulized steroids can be used);
- Asplenia or splenectomy, functional asplenia caused by any circumstances;
- Subjects with hypertension (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg, suitable for adults);
- Suffering from acute illness or in the acute phase of chronic illness, or using antipyretic, analgesic, and antiallergic drugs (such as acetaminophen, ibuprofen, aspirin, etc.) three days before the first dose of vaccination;
- Within 7 days (≤ 7 days) prior to enrollment, received inactivated vaccines, and within 14 days (≤ 14 days) received live attenuated vaccines;
- Has received blood or blood related products or immunoglobulin (hepatitis B immunoglobulin is acceptable) within 3 months prior to enrollment;
- Premature infants (gestational age<37 weeks), low birth weight infants (birth weight<2500g), and infants with a history of abnormal labor (only applicable to the 3-5 month and 6-23 month age groups);
- Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit;
- Participating in or planning to participate in clinical trials of other drugs in the near future;
- The researchers believe that there are any conditions in the subjects that may interfere with the evaluation of the research objectives.
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltdअध्ययन केंद्रीय संपर्क
संपर्क: Wenjian Fang, +86-18611630252, [email protected]
1 1 देशों में अध्ययन स्थल
Guangxi
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning, Guangxi, 530028, China
Lirong Huang, संपर्क, +86-13978620932
भर्ती जारी