Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Product characteristics: WIBP: The inactivated SARS CoV 2 Vaccine (Vero cell) is prepared by inoculating Verda Reno cells (Vero cell) with SARS CoV 2 WIV04 strain, culturing, harvesting, inactivating, clarifying, concentrating, second inactivating, purifying and adding aluminum hydroxide adjuvant BIBP: The inactivated SARS CoV 2 Vaccine (Vero cell) is prepared by inoculating Verda Reno cells (Vero cell) with SARS CoV 2 HB02 strain, culturing, harvesting, inactivating, clarifying, concentrating, purifying and adding aluminum hydroxide adjuvant. After vaccination, the body can produce immune response to prevent diseases caused by SARS CoV 2. Primary objective To evaluate the protective efficacy of inactivated SARS CoV 2 Vaccine (Vero Cell) after full course of immunization in preventing diseases caused by the SARS CoV 2 in healthy subjects aged 18 years old and above. Study design: This clinical trial is conducted in randomized, blind, placebo-controlled design. Total sample size is 12,000, which are randomly allocated into investigational vaccine 1, investigational vaccine 2 and placebo control group. Subjects with compatible symptoms, will be excluded. Immunization schedule: 2-doses of investigational vaccine or placebo are inoculated to the deltoid muscle of the upper arm according to the Day 0 and day 21 (window for both days + 7 days), immunization schedule. Safety observation After each dose of vaccination, the subject is observed for 30 minutes on site, and local and systemic adverse events are collected. Within 0-30 21/28 days, the local and systemic reactions of the subjects are actively followed up and recorded on the. telephone follow-up contact form. Serious adverse events (SAE) will be daily monitored within 12 months after vaccination, and followed up, recorded and reported as required. Observation of efficacy After the subjects are enrolled in the group, the monitoring of SARS-CoV-2 infection cases will begin Planned and active follow-up is carried out on the subjects, and a monitoring network is established in local medical and health institutions to monitor SARS-CoV-2 infection-like cases in the subjects. Those diagnosed as suspected cases by clinicians will be studied as epidemiological case, including nasopharyngeal swabs, sputum and/or other lower respiratory secretions, venous blood in acute and convalescent stages are collected. SARS-CoV-2 nucleic acid will be tested by RT-PCR method, and/or viral gene sequencing. Subjects with positive nucleic acid, or/and convalescent serum antibodies increased 4 fold or more than acute phase serum are confirmed cases of COVID-19. (refer to case monitoring operation manual). The incidence of confirmed SARS-CoV-2 disease in the three groups of study samples is calculated and the epidemiological protection rate and confidence interval of SARS-CoV-2 inactivated vaccines against SARS-CoV-2 disease are analyzed. Immunogenicity observation: Immunogenicity (antibody response to inactivated SARS-CoV-2 vaccine / placebo) will be evaluated in subjects V00001-V12000 on 14 days after 2nd dose (day 35) and 360 days after 2nd dose (day 381). Subgroups of 1200 participants will be registered on 28 days after 2nd dose (days 49), 180 days after 2nd dose ( day 201), to better precise the peak of neutralizing antibodies Case definition: Cases will be further classified as: Asymptomatic cases: No symptoms developed for 14 consecutive days after positive PCR testing. Confirmed cases: On the basis of the clarification of the suspected case, the COVID-19 PCR diagnosis is positive, or IgG antibodies in convalescent sera four times higher than baseline. Confirmed mild COVID-19 cases: The clinical symptoms were mild, and there was no sign of pneumonia on imaging. Confirmed moderate COVID-19 cases: Showing fever and respiratory symptoms with radiological findings of pneumonia. Confirmed severe COVID-19 cases: Confirmed COVID-19 case meeting any one of the following criteria: - Respiratory distress (RR≥30 breaths/min); - Oxygen saturation≤93% at rest; - Arterial partial pressure of oxygen (PaO2)/ fraction of inspired oxygen (FiO2)≦300mmHg (1mmHg=0.133kPa); - The clinical symptoms progressively worsened, and the chest imaging showed >50% obvious lesion progression within 24-48 hours. Confirmed Critical COVID-19 cases: Confirmed COVID-19 case meeting any one of the following criteria: - Respiratory failure and requiring mechanical ventilation; - Shock; - With other organ failure that requires ICU care; - Death ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04612972
Study type Interventional
Source Universidad Peruana Cayetano Heredia
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 9, 2020
Completion date December 19, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05047601 - A Post-Exposure Prophylaxis Study of PF-07321332/Ritonavir in Adult Household Contacts of an Individual With Symptomatic COVID-19 Phase 3
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Active, not recruiting NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Recruiting NCT05191394 - IMPACT OF THERAPEUTIC PLASMA EXCHANGE ON ACQUIRED VACCINAL ANTI-SARS-CoV-2 ANTIBODIES. N/A
Active, not recruiting NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Recruiting NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Enrolling by invitation NCT05089305 - Ozone Plasma on Lung Function and Inflammatory Parameters in Pulmonary Sequelae Associated With Coronavirus 19 Infection Phase 2
Recruiting NCT04357990 - Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19 N/A
Recruiting NCT04528901 - Study of seroPREvalence Vis-à-vis SARS-CoV2 and Correlation With Clinical Forms of COVID-19 in Patients Followed in Pneumology in the Cluster Area of the Grand-Est Region (Strasbourg University Hospital)
Active, not recruiting NCT04527471 - Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19 Phase 2
Recruiting NCT05022329 - COVID-19 Vaccine Boosters in Patients With CKD Phase 2/Phase 3
Recruiting NCT05047445 - A First Time in Human Phase 1 Open-Label Study of the COVIDITY Vaccine Administered by Needle-free Injection Phase 1
Recruiting NCT05041907 - Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) Phase 2
Not yet recruiting NCT04990466 - Phase 2b/3 Trial of VSV-ΔG SARS-CoV-2 Vaccine (BRILIFE) Against Approved Comparator Vaccine. Phase 2/Phase 3
Recruiting NCT04661462 - Health After Covid-19 in Tyrol
Not yet recruiting NCT04446065 - Previfenon® as Chemoprophylaxis of COVID-19 in Health Workers Phase 2/Phase 3
Recruiting NCT04526054 - Morphological Abnormalities of the Olfactory Bulb on MRI and Olfactometry in Anosmic Versus Normosmic COVID-19 Patients N/A