NCT04845048已完成不适用
Active Pharmacovigilance Study of Post-vaccine Adverse Events of Sinovac's/ Butantan Institute Adsorbed COVID-19 (Inactivated) Vaccine
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,549
- 试验地点
- 3
- 主要终点
- Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of participants who presented adverse reactions according to the age group
研究概览
简要总结
This is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the Adsorbed COVID-19 (Inactivated) Vaccine Sinovac / Institute Butantan.
详细描述
. This is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the Adsorbed COVID-19 (Inactivated) Vaccine Sinovac / Institute Butantan.
- The immunization schedule is two doses intramuscular injections (deltoid) with a 14-28 days interval.
- There will be 900 participants (300 health care professionals between 18 and 59 years old); 300 participants 75 years old or more; 300 participants between 60 and 74 years old. All participants must be allowed to receive the Adsorbed COVID-19 (inactivated) Vaccine according to the Brazilian Immunization National Plan.
- For safety analysis , the incidence of adverse events after receiving the Adsorbed COVID-19 (inactivated) Vaccine that needed health assistance until 42 days after two-doses immunization schedule.
- The total period of participation in the study will be approximately 60 days after completing the two-dose schedule of the vaccine.
- Active pharmacovigilance studies are essential to assess the safety profile of the vaccine in subgroups that will be included as target populations in the Immunization Program.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult allowed to receive the Adsorbed COVID-19 (inactivated) Vaccine according to the Immunization National Plan.
- •Informed consent form signed by participant.
- •Show voluntary intention to participate in the study and availability throughout the study.
排除标准
- •History of severe allergic reactions or anaphylaxis to previous vaccines or allergy to any components of the study vaccine.
- •History of fever (axillar temperature ≥ 37,8º C) 72 hours before the vaccine
- •Be unavailable during the study period.
- •Any other condition that, in the opinion of the principal investigator or his/her representative physician, could put the safety/rights of potential participants at risk or prevent them from complying with this protocol.
结局指标
主要结局
Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of participants who presented adverse reactions according to the age group
时间窗: 7 days after each dose of the vaccine
Frequency of participants who presented any solicited and non-solicited local and systemic adverse reactions according to age group and severity.
Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions.
时间窗: 7 days after each dose of the vaccine
Frequency of solicited and non-solicited local and systemic adverse reactions according to age group and severity.
次要结局
- Description of medications used after adverse event (AE)(The whole period of study (365 days after the second dose))
- Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions which needed medical care in participants >= 18 years.(42 days after any dose of the vaccine)
- Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions which required medical care in participants < 18 years.(365 days after the second dose of the vaccine.)
- Safety of the Adsorbed COVID-19 (inactivated) Vaccine through the incidence of adverse reactions.(First 30 minutes after each dose of the vaccine.)
- Incidence of serious adverse event (AE)(The whole period of study (365 days after the second dose))
- Incidence of adverse event of special interest (AESI)(The whole period of study (365 days after the second dose))
- Incidence of serious adverse event if a subject get pregnant (SAE)(From the recrod of pregnancy until the end of the study or upto the birth.)
研究者
研究点 (3)
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