SARS-CoV2 Infection
Conditions
Keywords
vaccine, SARS-CoV-2, infection
Brief summary
This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation
Detailed description
This trial is Randomized, observer-blind, placebo-controlled two arms parallel group, prospective intervention study Approximately 1620 subjects aged 18-59 years will be enrolled in this trial for efficacy evaluation. Subjects will be divided into 2 treatment arms that are the vaccinated group and placebo group with ratio 1:1. The vaccinated arms will be grouped into three different lot number (lot 1/lot 2/ lot 3) of SARS-CoV-2 vaccine.
Interventions
BIOLOGICALSARS-CoV-2 vaccine (inactivated)
SARS-CoV-2 vaccine (inactivated) manufactured by Sinovac
BIOLOGICALPlacebo
Placebo manufactured by PT. Bio Farma
Sponsors
Faculty of Medicine Universitas Padjadjaran
National Intitute of Health Research and Development, Ministry of Health Republic of Indonesia
Sinovac Life Sciences Co., Ltd.
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Observer blind Investigational Product and Active Comparator was masking Number of lot was masking
Intervention model description
Subjects 18-59 years of age: Randomized, observer blind, placebo-controlled two arms parallel group, prospective intervention study, to evaluate efficacy, safety, immunogenicity SARS-CoV-2 vaccine (inactivated)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
1. Clinically healthy adults aged 18 - 59 years. 2. Subjects have been informed properly regarding the study and signed the informed consent form. 3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.
Exclusion criteria
1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial. 2. Contact with novel coronavirus infected persons (positive for nucleic acid detection) within 14 days prior to the trial. 3. Contact to patients with fever or respiratory symptoms surrounding areas or from communities with reported cases within 14 days prior to the trial. 4. Two or more cases of fever and/or respiratory symptoms in a small area such as home, office, school and class within 14 days prior to the trial. 5. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). 6. The result of RT-PCR of swab nasopharyngeal is positive 7. Reactive IgG and IgM for SARS-CoV-2 (by standardize rapid test). 8. Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). 9. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. 10. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. 11. 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. 12. 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)). 13. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome 14. Subjects receive any vaccination within 1 month before and after IP immunization. 15. Subjects plan to move from the study area before the end of study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of laboratory-confirmed COVID-19 after the second dose | 14 days to 6 months after the second dose | Percentage of laboratory-confirmed COVID-19 cases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of laboratory-confirmed cases (severe, critical and death) | within 14 days to 6 months after the second dose | Percentage of laboratory-confirmed cases (severe, critical, death) |
| Incidence of suspected COVID-19 cases | within 14 days to 6 months after the second dose. | Percentage of suspected COVID-19 cases |
| Seroconversion rate anti-S antibody IgG titer (ELISA) | 14 days after two doses of vaccination | Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches |
| Seropositive rate of neutralizing antibodies | 14 days after two doses of vaccination | Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events during study | 6 months after the last dose | Number of any SAE occur |
| Local reaction and systemic events occurring after the last vaccination | 14 days to 28 days following last vaccination | Number of Local reactions and systemic events |
| Local reaction and systemic events | 30 minutes to 14 days after each vaccination | Number of Local reactions and systemic events |
Countries
Indonesia
Outcome results
None listed