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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. )

Tracking Information
First Submitted Date  ICMJE November 4, 2020
First Posted Date  ICMJE November 5, 2020
Last Update Posted Date July 27, 2021
Actual Study Start Date  ICMJE October 31, 2020
Actual Primary Completion Date November 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2020)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Covid19
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Aged 26-45, Commercial Scale
    Commercial scale inactivated SARS-CoV-2 vaccine in adults aged 26-45 years.
    Intervention: Biological: Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14
  • Experimental: Aged 18-59, Pilot Scale
    Pilot scale inactivated SARS-CoV-2 vaccine in adults aged 18-59 years.
    Intervention: Biological: Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14
  • Experimental: Aged ≥60, Pilot Scale
    Pilot scale inactivated SARS-CoV-2 vaccine in elderly aged above 60 years.
    Intervention: Biological: Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2020)
1040
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 31, 2021
Actual Primary Completion Date November 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04617483
Other Study ID Numbers  ICMJE PRO-nCOV-3001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sinovac Biotech Co., Ltd ( Sinovac Research and Development Co., Ltd. )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sinovac Research and Development Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hongxing Pan, Master Jiangsu Provincial Center for Disease Prevention and Control
PRS Account Sinovac Biotech Co., Ltd
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP