Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1620 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-10

Study Completion Date

2021-08-31

Brief Summary

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This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation

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Detailed Description

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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.

Conditions

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SARS-CoV2 Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Observer blind Investigational Product and Active Comparator was masking Number of lot was masking

Study Groups

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SARS-CoV-2 Vaccine

Participants receive 2 doses of SARS-CoV-2 Inactivated Vaccine with 14 days interval, intramuscularly

Group Type EXPERIMENTAL

SARS-CoV-2 vaccine (inactivated)

Intervention Type BIOLOGICAL

SARS-CoV-2 vaccine (inactivated) manufactured by Sinovac

Placebo

Participants receive 2 doses of placebo with 14 days interval, intramuscularly

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo manufactured by PT. Bio Farma

Interventions

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SARS-CoV-2 vaccine (inactivated)

SARS-CoV-2 vaccine (inactivated) manufactured by Sinovac

Intervention Type BIOLOGICAL

Placebo

Placebo manufactured by PT. Bio Farma

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes