Study of the Commercial Scale SARS-CoV-2 Vaccine Against the Pilot Scale Among Adults, and Bridging Study of the Immunogenicity in Elderly Against That in Adults

NCT ID: NCT04617483

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1040 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2021-05-31

Brief Summary

This study is a randomized, double-blinded clinical Trial, to evaluate the non-inferiority of the commercial scale Inactivated SARS-CoV-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults.

Detailed Description

This study is a randomized, double-blinded clinical Trial, to evaluate the non-inferiority of the commercial scale Inactivated SARS-CoV-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults. The experimental vaccine was manufactured by Sinovac Research & Development Co.,Ltd. Totally 1040 subjects，including: 130 subjects aged 18~25 years; 520 subjects aged 26~45 years, with 260 in each group; 130 subjects aged 46~59 years; 260 subjects aged ≥60 years.

Subjects will be assigned to receive two doses of medium-dosage vaccine on the schedule of 0,14.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Aged 26-45, Commercial Scale

Commercial scale inactivated SARS-CoV-2 vaccine in adults aged 26-45 years.

Group Type: EXPERIMENTAL

Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14

Intervention Type: BIOLOGICAL

The antigen content of the commercial scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 26-45.

Aged 18-59, Pilot Scale

Pilot scale inactivated SARS-CoV-2 vaccine in adults aged 18-59 years.

Group Type: EXPERIMENTAL

Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14

Intervention Type: BIOLOGICAL

The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 18-59.

Aged ≥60, Pilot Scale

Pilot scale inactivated SARS-CoV-2 vaccine in elderly aged above 60 years.

Group Type: EXPERIMENTAL

Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly

Intervention Type: BIOLOGICAL

The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group above 60.

Interventions

Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14

The antigen content of the commercial scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 26-45.

Intervention Type: BIOLOGICAL

Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14

The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 18-59.

Intervention Type: BIOLOGICAL

Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly

The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group above 60.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Healthy adults aged 18-59 or elderly aged ≥60 years;

2. Proven legal identity.

Exclusion Criteria

1. Travel/residence history of communities with reported cases within 14 days before trial;

2. History of exposure to Novel Coronavirus infection (nucleic acid positive) within 14 days prior to the trial;

3. Exposed to patients with fever or respiratory symptoms 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. History of SARS-CoV-2 infection;

6. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;

7. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;

8. Autoimmune disease or immunodeficiency/immunosuppression;

9. Patients with serious chronic diseases, serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc.;

10. Serious neurological disorder (epilepsy, convulsions or convulsions) or psychosis;

11. History of thyroid disease or thyroidectomy, absence of spleen, functional absence of spleen, and absence of spleen or splenectomy caused by any circumstance;

12. Coagulation dysfunction (such as coagulation factor deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder diagnosed by doctors;

13. Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis) in the past 6 months;

14. Long history of alcohol or drug abuse;

15. Received blood products within 3 months prior to receiving the vaccine;

16. Received other research drugs within 30 days prior to receiving the vaccine;

17. Received live attenuated vaccine within 14 days prior to receiving the vaccine;

18. Received subunit or inactivated vaccine within 7 days prior to receiving the vaccine;

19. Onset of various acute or chronic diseases within 7 days prior to the study;

20. Axillary temperature of >37.0℃ before inoculation of the vaccine;

21. Those who are already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to become pregnant within 2 months;

22. In the opinion of the investigator, the participants had any other factors that made them unsuitable to participate in the clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinovac Research and Development Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongxing Pan, Master

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Center for Disease Prevention and Control

Locations

Dafeng District Center for Disease Prevention and Control

Yancheng, Jiangsu, China

Countries

China

Other Identifiers

PRO-nCOV-3001

Identifier Type: -

Identifier Source: org_study_id