Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine
COVID-19
A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia
1 other identifier
interventional
1,620
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2020
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2020
CompletedStudy Start
First participant enrolled
August 10, 2020
CompletedFirst Posted
Study publicly available on registry
August 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedJanuary 13, 2022
December 1, 2021
5 months
August 7, 2020
December 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of laboratory-confirmed COVID-19 after the second dose
Percentage of laboratory-confirmed COVID-19 cases
14 days to 6 months after the second dose
Secondary Outcomes (6)
Incidence of suspected COVID-19 cases
within 14 days to 6 months after the second dose.
Incidence of laboratory-confirmed cases (severe, critical and death)
within 14 days to 6 months after the second dose
Seroconversion rate anti-S antibody IgG titer (ELISA)
14 days after two doses of vaccination
Seroconversion rate anti-S antibody IgG titer (ELISA)
6 months after two doses of vaccination
Seropositive rate of neutralizing antibodies
14 days after two doses of vaccination
- +1 more secondary outcomes
Other Outcomes (3)
Local reaction and systemic events
30 minutes to 14 days after each vaccination
Local reaction and systemic events occurring after the last vaccination
14 days to 28 days following last vaccination
Serious adverse events during study
6 months after the last dose
Study Arms (2)
SARS-CoV-2 Vaccine
EXPERIMENTALParticipants receive 2 doses of SARS-CoV-2 Inactivated Vaccine with 14 days interval, intramuscularly
Placebo
PLACEBO COMPARATORParticipants receive 2 doses of placebo with 14 days interval, intramuscularly
Interventions
SARS-CoV-2 vaccine (inactivated) manufactured by Sinovac
Eligibility Criteria
You may qualify if:
- Clinically healthy adults aged 18 - 59 years.
- Subjects have been informed properly regarding the study and signed the informed consent form.
- Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.
You may not qualify if:
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- Contact with novel coronavirus infected persons (positive for nucleic acid detection) within 14 days prior to the trial.
- Contact to patients with fever or respiratory symptoms surrounding areas or from communities with reported cases within 14 days prior to the trial.
- 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.
- Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
- The result of RT-PCR of swab nasopharyngeal is positive
- Reactive IgG and IgM for SARS-CoV-2 (by standardize rapid test).
- 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).
- 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 within 1 month before and after IP immunization.
- Subjects plan to move from the study area before the end of study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hasan Sadikin Hospital/School of Medicine, Padjadjaran University
Bandung, West Java, Indonesia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Observer blind Investigational Product and Active Comparator was masking Number of lot was masking
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2020
First Posted
August 11, 2020
Study Start
August 10, 2020
Primary Completion
January 9, 2021
Study Completion
August 31, 2021
Last Updated
January 13, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share