Re-examination Study for General Vaccine Use to Assess the Safety Profile of Varivax in Usual Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 754
- 主要终点
- Percentage of Participants With One or More Adverse Drug Reactions (ADRs)
研究概览
简要总结
This survey is conducted for preparing application materials for re-examination under the Korean Pharmaceutical Affairs Laws and its Enforcement Regulation; its aim is to reconfirm the clinical usefulness of VARIVAX through collecting the safety information according to the Re-examination Regulation for New Drugs.
详细描述
This post-marketing survey was conducted in the usual routine practice and the investigator enrolled participants vaccinated with VARIVAX continuously after study start. The purpose of the study was to assess the occurrence of adverse events and to identify factors that may affect the safety of the vaccine under real-life, post-marketing conditions. No hypothesis testing was conducted in this survey.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be vaccinated with VARIVAX as a standard of care
排除标准
- •Participants who have been previously vaccinated with VARIVAX
- •Contraindication with VARIVAX
结局指标
主要结局
Percentage of Participants With One or More Adverse Drug Reactions (ADRs)
时间窗: Up to 42 days after vaccination
An ADR is an AE (defined above) for which relatedness to the use of the product cannot be ruled out
Percentage of Participants With One or More Unexpected AEs
时间窗: Up to 42 days after vaccination
Unexpected AEs differed from AEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome
Percentage of Participants With One or More AEs by Age
时间窗: Up to 42 days after vaccination
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event. Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time.
Percentage of Participants With One or More Serious Adverse Events (SAEs)
时间窗: Up to 42 days after vaccination
An SAE is any AE that results in death, is life-threatening, results in persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event based on appropriate medical judgment.
Percentage of Participants With One or More Serious ADRs
时间窗: Up to 42 days after vaccination
A serious ADR is an SAE (defined above) for which relatedness to the use of the product cannot be ruled out
Percentage of Participants With One or More Unexpected SAEs
时间窗: Up to 42 days after vaccination
Unexpected SAEs differed from SAEs reported in the VARIVAX product label with regard to their identity, severity, specificity, or outcome
Percentage of Participants With One or More Adverse Events (AEs)
时间窗: Up to 42 days after vaccination
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event. Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time.
Percentage of Participants With One or More AEs by Gender
时间窗: Up to 42 days after vaccination
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study vaccine, is also an adverse event. Changes resulting from normal growth and development which do not vary significantly in frequency or severity from expected levels are not to be considered adverse events. Examples of this may include, but are not limited to, teething, typical crying in infants and children, and onset of menses or menopause occurring at a physiologically appropriate time.
Percentage of Participants With One or More Unexpected ADRs
时间窗: Up to 42 days after vaccination
An unexpected ADR is an unexpected AE (defined above) for which relatedness to the use of the study vaccine cannot be ruled out
次要结局
未报告次要终点