NCT06389513已完成4 期
Phase IV Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,011
- 试验地点
- 1
- 主要终点
- Incidence of localized adverse reactions in subjects
研究概览
简要总结
This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine, and to administer a total of 3 doses of Menhycia®, with a minimum of 1 month between doses, and a booster dose of 1 dose of immunization is allowed at 12 months of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants 3 months of age who had not received any epidemic encephalitis vaccine at the time of screening
- •The legal guardian or delegate has given informed consent, has voluntarily signed an informed consent form, and is able to comply with the requirements of the clinical study protocol
排除标准
- •First dose exclusion criteria
- •Fever before vaccination, axillary temperature >37.0°C
- •Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- •History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders
- •Acute infections or active chronic diseases, severe infectious or allergic skin diseases
- •Known allergy to a component of the vaccine, especially to diphtheria toxoid, or to previous administration of the product
- •Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate
- •Subsequent dose exclusion criteria
- •Severe allergic reactions after a previous dose of vaccine
- •Those with serious adverse reactions causally related to the previous dose of vaccination
- •Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate
研究组 & 干预措施
ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4)
Experimental
Intramuscular injection, 0.5ml
干预措施: MCV4 (Biological)
结局指标
主要结局
Incidence of localized adverse reactions in subjects
时间窗: Within 7 days after each dose of vaccination
Incidence of systemic adverse reactions in subjects
时间窗: Within 7 days after each dose of vaccination
次要结局
- Incidence of adverse events in subjects(Within 30 days after each dose of vaccination)
- Incidence of adverse reactions in subjects(Within 30 days after each dose of vaccination)
- Incidence of severe adverse events(Through study completion, an average of 10 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Safety and Immunogenicity of 1 or 2 Doses of IPV in Latin American Infants Primed With Bivalent OPV VaccinePoliomyelitisNCT01831050Fidec Corporation1,420
尚未招募
4 期
Study to evaluate the effects of the COVID-19 (inactivated) vaccine of the Instituto Butantan in immucompromised personsChronic kidney diseaseRespiratory diseasesCOVID-19Immunocompromised hostsTransplant recipientsLiver cirrhosisNeoplasmsPrimary immunodeficiency diseasesC01.918RBR-9ksh5f4Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
已完成
1 期
Study To Evaluate The Safety, Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma (MCC)Merkel Cell CarcinomaNCT05422781Immunomic Therapeutics, Inc.6
已完成
4 期
Safety, Tolerability, and Immunogenicity of Vaxelis™ in Children Previously Vaccinated With Vaxelis™ or Hexyon™ (V419-016)Vaccines, CombinedHexavalent VaccineNCT05289271Merck Sharp & Dohme LLC168
进行中（未招募）
1 期
A clincal study to evaluate the safety of a polio vaccine type 2 given orally in healthy children aged 1 to 5 years previously treated with inactivated polio vaccine in Lithuaniaevaluation of safety of SABIN mOPV2 in healthy IPV-vaccinated children of 1 – 5 years of age (Polio disease)MedDRA version: 18.0Level: LLTClassification code 10036016Term: Poliomyelitis NOSSystem Organ Class: 100000004862EUCTR2015-003544-39-LTFIDEC - Fighting Infectious Diseases in Emerging Countries