Freeze-dried Live Attenuated Measles and Rubella Combined Vaccine "Takeda" Special Drug Use Surveillance of Vaccinees After the First Vaccination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,493
- 主要终点
- Number of Participants With Serious Adverse Drug Reactions
研究概览
简要总结
The purpose of this survey is to assess the safety freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live attenuated measles and rubella combined vaccine "Takeda") in terms of the occurrence of unknown/known adverse drug reactions and factors that may influence the safety of vaccinees after the first vaccination.
详细描述
This survey was designed to assess the safety of live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live attenuated measles and rubella combined vaccine "Takeda") in terms of the occurrence of unknown/known adverse drug reactions and factors that may influence the safety of vaccinees after the first vaccination.
Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 mL of accompanying reconstitution fluid (water for injection [Japanese Pharmacopoeia]), wherein a 0.5-mL portion is typically administered subcutaneously as a single dose.
In addition, freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) should be used in accordance with the "Regulations for Vaccination" and the "Guidelines for Routine Vaccination."
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vaccinees who meet both of the following conditions [1] and [2]:
- •Vaccinees who have no prior history of either measles or rubella vaccination and who received freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) as the initial vaccination.
- •Vaccinees whose guardians are able to participate in a questionnaire survey on the health status of vaccinees after vaccination with freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain).
排除标准
- 未提供
研究组 & 干预措施
Live attenuated measles/rubella combined vaccine
Live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 milliliter (mL) of accompanying reconstitution fluid (water for injection [Japanese Pharmacopoeia]), and a 0.5-mL portion is typically administered subcutaneously as a single dose.
干预措施: Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (Drug)
结局指标
主要结局
Number of Participants With Serious Adverse Drug Reactions
时间窗: Baseline up to Day 28
Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Frequency of adverse events and factors that may influence safety were not to be assessed as endpoints of this study and were registered as endpoints by mistake. Instead, adverse drug reactions were assessed as endpoint.
次要结局
- Number of Participants Reporting One or More Adverse Drug Reactions(Baseline up to Day 28)