Immuno-bridging Study of Inactivated SARS-CoV-2 Vaccine in Healthy Population Aged 3-17 vs Aged 18 Years Old and Above (COVID-19)

Immunogenicity Non-inferiority Immuno-bridging Study of Inactivated SARS-CoV-2 Vaccine in Healthy Population Aged 3-17 Years Old vs Healthy Population Aged 18 Years Old and Above

This is a open label clinical trial to evaluate the efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines (Vero cell) in healthy people aged 3-17 years old in comparison with healthy population aged 18 years old and above

Study Overview

• Status: Completed
• Conditions: COVID-19; COVID-19 Pneumonia
• Intervention / Treatment: Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated

Detailed Description

This is a open label clinical trial to evaluate the efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines (Vero cell) developed by Beijing Institute of Biological Products Co., Ltd in healthy people aged 3-17 years old in comparison with healthy population aged 18 years old and above. Total of 1800 healthy volunteers aged 3 years old and above will be enrolled, of whom the subjects will be divided into two groups, 3-17 years old group and 18 years old and above group with each consisting of 900 volunteers. The 3-17 years old group was further divided into three subgroups: 3-6 years old, 7-12 years old and 13-17 years old, with 300 volunteers in each subgroup. 2 doses of vaccines will be injected into the deltoid muscle of either upper arm according to the immunization schedule of D0, D21 (+7 Days). Based on interim analysis'results of the booster dose administered to adults aged 18 years old and above, a booster dose might be introduced.

• Study Type: Interventional
• Enrollment (Actual): 1800
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhabi, United Arab Emirates, 51900
    • Sheikh Khalifa Medical City, SEHA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy subjects aged 3 years old and above
• Medical history and physical examination of the subject confirms the subject is in a healthy condition and is approved by the investigator
• Female subjects of childbearing age who 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.
• The subject must be able and willing to complete the whole immunization schedule of the study and be able to follow up study procedures for 6 months.
• With self-ability to understand the study procedures, the informed consent & voluntarily sign an informed consent/ assent form. Legal authority or parents/guardians of minors 3-17 years should sign an informed consent form and be able to comply with the requirements of the clinical study protocol.

Exclusion Criteria:

• Confirmed acute cases of SARS-CoV-2 infection.
• With a medical history of SARS, MERS virus infection (self-report, on-site inquiry);
• Fever (axillary temperature > 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea within 14 days before vaccination (Tympanic temperature / Temporal artery temperature >37.5 ℃);
• Positive urine pregnancy test result.
• Body temperature axillary ≥ 37.0 ℃ before vaccination（Tympanic temperature / Temporal artery temperature≥ 37.5 ℃);
• With previous severe allergic reactions (such as acute allergic reactions, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of the inactivated SARS-CoV-2 vaccine.
• With a medical history or a family history of convulsion, epilepsy, encephalopathy or mental illness.
• With congenital malformation or developmental disorder, genetic defects, severe malnutrition, etc.;
• With known or suspected diseases include acute respiratory diseases (e.g. influenza like illness, acute cough, sore throat), severe cardiovascular diseases, severe liver diseases, severe kidney diseases, 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.
• Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; With a history of coagulation dysfunction (such as coagulation factor deficiency, coagulation disease);
• With a history of coagulation dysfunction (such as coagulation factor deficiency coagulation disease);
• Receiving anti-TB therapy.
• Receiving immune enhancement or inhibitor therapy within 3 months (continuous oral or IV administration for more than 14 days);
• Vaccinated live attenuated vaccine within 1 month before vaccination and other vaccines within 14 days before vaccination;
• Received blood products within 3 months before vaccination;
• Received other investigational drugs within 6 months before vaccination;
• Other circumstances judged by investigators that were not suitable for participating in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aged 3-6 years old; 300 subjects receive 2 dose according to the immunization schedule of D0, D21 (+7 Days). A booster dose might be introduced.	Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated; 0.5 mL per dose, containing 6.5U inactivated SARS-CoV-2 antigen
Experimental: Aged 7-12 years old; 300 subjects receive 2 dose according to the immunization schedule of D0, D21 (+7 Days). A booster dose might be introduced.	Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated; 0.5 mL per dose, containing 6.5U inactivated SARS-CoV-2 antigen
Experimental: Aged 13-17 years old; 300 subjects receive 2 dose according to the immunization schedule of D0, D21 (+7 Days). A booster dose might be introduced.	Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated; 0.5 mL per dose, containing 6.5U inactivated SARS-CoV-2 antigen
Active Comparator: Aged ≥18 years old; 300 subjects receive 2 dose according to the immunization schedule of D0, D21 (+7 Days). A booster dose might be introduced.	Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated; 0.5 mL per dose, containing 6.5U inactivated SARS-CoV-2 antigen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody	≥4 fold increase from baseline	28 days after 2 dose of immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody	Neutralizing antibody assay will be performed using the Microcytopathic assay	28 days after 2 dose of immunization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety index-Incidence of adverse reactions	the adverse event at injection site and systemic adverse event and other adverse events of the subjects are actively followed up and recorded in the subject diary card or follow-up calls	From the beginning of the vaccination to 28 days after the full course immunization
Safety index-Incidence of serious adverse events	All SAEs will be collected	From the beginning of the vaccination to 6 months after the full course immunization
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody	≥4 fold increase from baseline	28 days after booster dose of immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody	Neutralizing antibody assay will be performed using the Microcytopathic assay	28 days after booster dose of immunization
The distribution of neutralizing antibody titer	The proportions of neutralizing antibody titer	28 days after 2 dose of immunization and booster dose

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Beijing Institute of Biological Products Co Ltd.
• Investigators: Principal Investigator: Nawal Al Kaabi, MD, Sheikh Khalifa Medical City

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): April 29, 2022

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; SARS-CoV-2 Vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CNBG2021001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No