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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

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ClinicalTrials.gov Identifier: NCT04617483
Recruitment Status : Completed
First Posted : November 5, 2020
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd ( Sinovac Research and Development Co., Ltd. )

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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 Biological: Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 Biological: Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1040 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: The first part of the study is a double-blinded trial, the second part is a open-label research.
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : October 31, 2020
Actual Primary Completion Date : November 28, 2020
Actual Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aged 26-45, Commercial Scale
Commercial scale inactivated SARS-CoV-2 vaccine in adults aged 26-45 years.
Biological: 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.

Experimental: Aged 18-59, Pilot Scale
Pilot scale inactivated SARS-CoV-2 vaccine in adults aged 18-59 years.
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.

Experimental: Aged ≥60, Pilot Scale
Pilot scale inactivated SARS-CoV-2 vaccine in elderly aged above 60 years.
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.




Primary Outcome Measures :
  1. Immunogenicity index-geometric mean titer(GMT) of neutralizing antibody [ Time Frame: Day 14 after the full course vaccination ]
    Neutralizing antibody assay will be performed using the micro-neutralization method


Secondary Outcome Measures :
  1. Immunogenicity index-Seroconversion rate of the neutralizing antibody [ Time Frame: Day 14 after the full course vaccination ]
    Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative(<1:8) to seropositive(≥1:8), or ≥4 fold increase from baseline

  2. Immunogenicity index-Seropositive rate of the neutralizing antibody [ Time Frame: Day 14 after the full course vaccination ]
    Neutralizing antibody assay will be performed using the micro-neutralization method. Subjects with a antibody titer ≥1:8 will defined as seropositive

  3. Safety index-Incidence of adverse reactions [ Time Frame: From the beginning of the vaccination to 28 days after the full course vaccination ]
    Incidence of adverse reactions from the beginning of the vaccination to 28 days after the full course vaccination

  4. Safety index-Incidence of serious adverse events [ Time Frame: From the beginning of the vaccination to 6 months after the full course vaccination ]
    SAE will be collected throughout the clinical trial



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04617483


Locations
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China, Jiangsu
Dafeng District Center for Disease Prevention and Control
Yancheng, Jiangsu, China, 224100
Sponsors and Collaborators
Sinovac Research and Development Co., Ltd.
Investigators
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Principal Investigator: Hongxing Pan, Master Jiangsu Provincial Center for Disease Prevention and Control
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Responsible Party: Sinovac Research and Development Co., Ltd.
ClinicalTrials.gov Identifier: NCT04617483    
Other Study ID Numbers: PRO-nCOV-3001
First Posted: November 5, 2020    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs