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Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine (COVID-19)

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ClinicalTrials.gov Identifier: NCT04508075
Recruitment Status : Completed
First Posted : August 11, 2020
Last Update Posted : September 8, 2021
Sponsor:
Collaborators:
Faculty of Medicine Universitas Padjadjaran
National Intitute of Health Research and Development, Ministry of Health Republic of Indonesia
Sinovac Life Sciences Co., Ltd.
Information provided by (Responsible Party):
PT Bio Farma

Tracking Information
First Submitted Date  ICMJE August 7, 2020
First Posted Date  ICMJE August 11, 2020
Last Update Posted Date September 8, 2021
Actual Study Start Date  ICMJE August 10, 2020
Actual Primary Completion Date January 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2020)
Incidence of laboratory-confirmed COVID-19 after the second dose [ Time Frame: 14 days to 6 months after the second dose ]
Percentage of laboratory-confirmed COVID-19 cases
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2020)
  • Incidence of suspected COVID-19 cases [ Time Frame: within 14 days to 6 months after the second dose. ]
    Percentage of suspected COVID-19 cases
  • Incidence of laboratory-confirmed cases (severe, critical and death) [ Time Frame: within 14 days to 6 months after the second dose ]
    Percentage of laboratory-confirmed cases (severe, critical, death)
  • Seroconversion rate anti-S antibody IgG titer (ELISA) [ Time Frame: 14 days after two doses of vaccination ]
    Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches
  • Seroconversion rate anti-S antibody IgG titer (ELISA) [ Time Frame: 6 months after two doses of vaccination ]
    Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches
  • Seropositive rate of neutralizing antibodies [ Time Frame: 14 days after two doses of vaccination ]
    Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches
  • Seropositive rate of neutralizing antibodies [ Time Frame: 6 months after two doses of vaccination ]
    Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 8, 2020)
  • Local reaction and systemic events [ Time Frame: 30 minutes to 14 days after each vaccination ]
    Number of Local reactions and systemic events
  • Local reaction and systemic events occurring after the last vaccination [ Time Frame: 14 days to 28 days following last vaccination ]
    Number of Local reactions and systemic events
  • Serious adverse events during study [ Time Frame: 6 months after the last dose ]
    Number of any SAE occur
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine
Official Title  ICMJE A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia
Brief Summary This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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)
Masking: Double (Participant, Investigator)
Masking Description:
Observer blind Investigational Product and Active Comparator was masking Number of lot was masking
Primary Purpose: Prevention
Condition  ICMJE SARS-CoV2 Infection
Intervention  ICMJE
  • Biological: SARS-CoV-2 vaccine (inactivated)
    SARS-CoV-2 vaccine (inactivated) manufactured by Sinovac
  • Biological: Placebo
    Placebo manufactured by PT. Bio Farma
Study Arms  ICMJE
  • Experimental: SARS-CoV-2 Vaccine
    Participants receive 2 doses of SARS-CoV-2 Inactivated Vaccine with 14 days interval, intramuscularly
    Intervention: Biological: SARS-CoV-2 vaccine (inactivated)
  • Placebo Comparator: Placebo
    Participants receive 2 doses of placebo with 14 days interval, intramuscularly
    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 Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2020)
1620
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 31, 2021
Actual Primary Completion Date January 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04508075
Other Study ID Numbers  ICMJE CoV2-0320
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party PT Bio Farma
Study Sponsor  ICMJE PT Bio Farma
Collaborators  ICMJE
  • Faculty of Medicine Universitas Padjadjaran
  • National Intitute of Health Research and Development, Ministry of Health Republic of Indonesia
  • Sinovac Life Sciences Co., Ltd.
Investigators  ICMJE Not Provided
PRS Account PT Bio Farma
Verification Date September 2021

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