A Phase III, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Aged 12-17 Years in Indonesia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- PT Bio Farma
- 入组人数
- 1,050
- 试验地点
- 10
- 主要终点
- To evaluate immunogenic non-inferiority immune response of SARS-CoV-2 neutralizing antibody of Bio Farma vaccine compared to vaccine control at 14 days after primary series
研究概览
简要总结
A Phase III, Observer-blind, randomized, active-controlled prospective intervention study
详细描述
This trial is randomized, prospective intervention study. A total of 1,050 subjects aged 12-17 years (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial.
The subjects will be divided into twostudy subsets, namely Main Study and Exploratory Study.
Main Study for immunogenicity and safety evaluation.
Exploratory Study for cellular immunity evaluation,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Vaccine candidate and active comparator are masking
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 aged 12-17 years.
- •Parent and/or legal guardian has been informed properly regarding the study and signed the informed consent form (and assent for subjects aged 12-17 years).
- •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
- •Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- •History of vaccination with any COVID-19 vaccine (based on anamnesis).
- •Subjects who have history of COVID-19 in the last 3 months (based on anamnesis).
- •Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
- •History of 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
COVID-19 Protein Subunit Recombinant Vaccine
2 doses of COVID-19 Protein Subunit Recombinant Vaccine administered with 28 days interval (0.5 mL per dose)
干预措施: SARS-CoV-2 Protein Subunit Recombinant Vaccine (Biological)
Active Comparator
2 doses of Covovax® - administered with 28 days interval (0.5 mL per dose)
干预措施: Active Comparator (Biological)
结局指标
主要结局
To evaluate immunogenic non-inferiority immune response of SARS-CoV-2 neutralizing antibody of Bio Farma vaccine compared to vaccine control at 14 days after primary series
时间窗: 14 days after primary series
Geometric Mean Titer (GMT) and GMT ratio of neutralizing antibody to the SARS-CoV-2, measured by neutralization assay (against omicron variant) at 14 days after primary series
次要结局
- To compare safety between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.(28 days after each dose)
- To evaluate SARS-CoV-2 (RBD)-binding IgG antibody titer before and 14 days after primary series of Bio Farma vaccine.(14 days after primary series)
- To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma).(12 months after primary series)
- To compare immunogenicity between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group.(28 days after each dose)
- To evaluate antibody persistence 3, 6 and 12 months after primary series(3, 6 and 12 months after primary series)