A Multicenter Post Marketing Surveillance Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ACWY Conjugate Vaccine(MenACWY-CRM) Administered According to the Prescribing Information to Healthy Subjects From 2 Months to 55 Years of Age in the Republic of South Korea.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,948
- 试验地点
- 55
- 主要终点
- Number of Subjects Reporting Medically Attended AEs (MAAEs)
研究概览
简要总结
A multicenter, single arm, post-marketing surveillance study. This study is a postlicensure requirement of the Korea Food and Drug Administration (KFDA) to provide continued safety evaluation of MenACWY in the Korean population from 2 months to 55 years of age, receiving MenACWY-CRM vaccination according to routine clinical practice and prescribing information.
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
- 2 Months 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals eligible for enrolment in this study are those:
- •male and female subjects from 2 months to 55 years of the age at the time of Visit 1 (including all 55 years old subjects, up to one day before their 56th year birthday), who are scheduled to receive vaccination with MenACWY-CRM conjugate vaccine, according to the local prescribing information and routine clinical practice;
- •to whom the nature of the study has been described and the subject or subject's parent/legal representative has provided written informed consent;
- •whom the investigator believes that the subject can and will comply with the requirements of the protocol (e.g., completion of the Diary Card);
- •who are in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator.
排除标准
- •Contraindication, special warnings and/or precautions, as evaluated by the investigators, reported in the MenACWY-CRM conjugate vaccine Korean prescribing information. In particular, should not be included in the study a subject who has ever had:
- •an allergic reaction to the active substances or any of the other ingredients of the study vaccine; an allergic reaction to diphtheria toxoid;
- •an illness with high fever; however, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination. Special care should be taken for subjects having haemophilia or any other problem that may stop your blood from clotting properly, such as persons receiving blood thinners (anticoagulants).
研究组 & 干预措施
MenACWY-CRM Group
Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.
干预措施: MenACWY-CRM (Menveo) (Biological)
结局指标
主要结局
Number of Subjects Reporting Medically Attended AEs (MAAEs)
时间窗: From Day 1 of vaccination to study termination (Day 29/early termination)
MAAEs are defined as events that require a physician's visit or an emergency room visit. All reported MAAEs from day 1 to day 29 were assessed. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
时间窗: From Day 1 of vaccination to Day 7 post vaccination
Assessed solicited local AEs include: injection site erythema, injection site induration, injection site tenderness, injection site pain. Assessed solicited systemic AEs include: change in eating habits, sleepiness, irritability, rash, vomiting, diarrhea, fever, chills, nausea, malaise, generalized myalgia, generalized arthralgia, headache. "Any" is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
时间窗: From Day 1 of vaccination to Day 7 post vaccination
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. All unsolicited AEs reported from day 1 to day 7 post vaccination were assessed. "Any" is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Number of Subjects Reporting Serious AEs (SAEs)
时间窗: From Day 1 of vaccination to study termination (Day 29/early termination)
An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); it does not refer to an event which hypothetically might have caused death if it were more severe, requires or prolongs subject's hospitalization, results in persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions), results in a congenital anomaly/birth defect, is an important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
次要结局
未报告次要终点