NCT05727215已完成2 期
Immunogenicity and Safety of IndoVac® as a Heterologous Booster Dose Against COVID-19 in Children 12-17 Years of Age
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Immunogenicity of the candidate vaccine
研究概览
简要总结
The goal of this clinical trial is to evaluate immune response and safety of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac) as a heterologous booster dose in healthy children 12-17 years of age.
Participants who had received complete primary doses of inactivated (Sinovac®) COVID-19 Vaccine will be given IndoVac as a booster dose.
详细描述
This trial is open label prospective intervention study. In this study 150 subjects who had received complete primary doses of inactivated (Sinovac®) COVID-19 Vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial.
Subject will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac).
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically healthy children 12-17 years of age.
- •Subjects who have previously received complete primary series of inactivated (Sinovac®) COVID-19 vaccine with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion.
- •Parent/legal guardian and subject has been informed properly regarding the study, and signed the informed consent form (parent/legal guardian) and assent form (subject).
- •Parent and/or legal guardian will commit to comply with the instructions of the investigator and the schedule of the trial.
排除标准
- •Subject concomitantly enrolled or scheduled to be enrolled in another trial.
- •Subject who has received booster dose of COVID-19 vaccine.
- •Subject who has history of COVID-19 in the last 3 months (based on anamnesis or other examinations).
- •Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
- •History of uncontrolled asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
- •History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- •Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.
- •Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)).
- •Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
- •Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
- •Female who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
- •Subjects plan to move from the study area before the end of study period.
研究组 & 干预措施
Primary dose of inactivated (Sinovac®) vaccine
Experimental
Subject who had received a complete primary dose of inactivated (Sinovac®) vaccine
干预措施: SARS-CoV-2 subunit protein recombinant vaccine (Biological)
结局指标
主要结局
Immunogenicity of the candidate vaccine
时间窗: 14 days after booster vaccination
Geometric Mean Titer (GMT) and GMFR of neutralizing antibody to the SARS-CoV-2
次要结局
- Seropositive rate and GMT of candidate vaccine(baseline, 14 days, 3 months, 6 months, and 12 months after booster vaccination)
- Seroconversion rate of candidate vaccine(baseline and 14 days after booster vaccination)
- Seropositive rate of the candidate vaccine(baseline, 14 days, 3 months, 6 months, and 12 months after booster vaccination)
- Seroconversion rate of the candidate vaccine(baseline and 14 days after booster vaccination)
- Safety of the candidate vaccine(30 minutes, 7 days, 28 days, and until 12 months after booster vaccination)
- Serious Adverse Event (SAE) of the vaccine(until 12 months after booster vaccination)
研究者
研究点 (1)
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