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A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above (COVID-19)

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ClinicalTrials.gov Identifier: NCT04510207
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : October 30, 2020
Sponsor:
Collaborators:
G42 Healthcare company
Abu Dhabi Health Services Company
Wuhan Institute of Biological Products Co., Ltd
Beijing Institute of Biological Products Co., Ltd
Information provided by (Responsible Party):
China National Biotec Group Company Limited

Tracking Information
First Submitted Date  ICMJE August 3, 2020
First Posted Date  ICMJE August 12, 2020
Last Update Posted Date October 30, 2020
Actual Study Start Date  ICMJE July 16, 2020
Estimated Primary Completion Date March 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
The incidence of COVID-19 cases after two-doses of vaccination [ Time Frame: From14 days after the second dose to 6 month after the second dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
  • The incidence of severe cases of SARS-CoV-2 pneumonia and deaths accompanied by COVID-19 after two-doses of vaccination [ Time Frame: From14 day after the second dose to 6 month after the second dose ]
  • The incidence of any adverse reactions/events [ Time Frame: 28 days after each immunization ]
  • The incidence of serious adverse events (SAE) [ Time Frame: From the beginning of the first dose to 12 months after the second immunization ]
  • The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days after full course of immunization ]
  • The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days after full course of immunization ]
  • The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 14 days after full course of immunization ]
  • The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization ]
  • The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization ]
  • The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody [ Time Frame: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 10, 2020)
  • the anti-SARS-CoV-2 neutralizing antibody protective level against COVID-19 [ Time Frame: 14 days after 2 doses of vaccination ]
  • The occurrence of ADE [ Time Frame: From the beginning of the first dose to 12 months after the second immunization ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate The Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above
Official Title  ICMJE Multicenter, Randomized, Double Blind, Parallel Placebo Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above
Brief Summary This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
    The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
  • Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
    The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP
  • Biological: Placebo
    The placebo of inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
Study Arms  ICMJE
  • Experimental: Investigational Vaccine1
    Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by WIBP according to the immunization schedule of D0 & D21.
    Intervention: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
  • Experimental: Investigational Vaccine 2
    Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by BIBP according to the immunization schedule of D0 & D21.
    Intervention: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
  • Placebo Comparator: Placebo
    Participants will receive 2 doses of Placebo according to the immunization schedule of D0 & D21.
    Intervention: Biological: Placebo
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2020)
45000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 16, 2021
Estimated Primary Completion Date March 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy subjects aged 18 years old and above.
  2. By asking for medical history and physical examination, the investigator judged that the health condition is well.
  3. Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
  4. During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan.
  5. With self-ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and be able to comply with the requirements of the clinical study protocol.

Exclusion Criteria:

  1. Confirmed acute cases of SARS-CoV-2 Infection.
  2. Have a history of SARS, MERS infection (self-report, on-site inquiry).
  3. Positive urine pregnancy test result.
  4. Fever (body temperature > 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination.
  5. Axillary body temperature > 37.0 ℃ before vaccination.
  6. Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred.
  7. Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history.
  8. With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
  9. With severe liver diseases, severe kidney diseases defined as eGFR less than 60, uncontrollable hypertension (systolic blood pressure >150 mmHg, diastolic blood pressure > 90 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases.
  10. Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases.
  11. With known or suspected diseases include acute respiratory diseases (e.g. influenza like illness, acute cough, sore throat), severe cardiovascular diseases, liver and kidney diseases, and malignant tumors.
  12. Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease).
  13. Receiving anti-TB therapy.
  14. Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days).
  15. Live attenuated vaccine is inoculated within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination.
  16. Received blood products within 3 months before this vaccination
  17. Received other research drugs within 6 months before this vaccination.
  18. Other circumstances judged by investigators that are not suitable for this 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: Yunkai Yang, Prof. +8613601126881 yangyunkai@sinopharm.com
Listed Location Countries  ICMJE Bahrain,   Egypt,   Jordan,   United Arab Emirates
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04510207
Other Study ID Numbers  ICMJE CNBG2020003SQ
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
Plan to Share IPD: No
Responsible Party China National Biotec Group Company Limited
Study Sponsor  ICMJE China National Biotec Group Company Limited
Collaborators  ICMJE
  • G42 Healthcare company
  • Abu Dhabi Health Services Company
  • Wuhan Institute of Biological Products Co., Ltd
  • Beijing Institute of Biological Products Co., Ltd
Investigators  ICMJE
Study Director: Walid A Zaher, MD, MSc,PhD G42 Healthcare company
PRS Account China National Biotec Group Company Limited
Verification Date October 2020

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