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

NCT04917523 | Completed Phase 3 DMC

• 1 other identifier: CNBG2021001
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19 Pneumonia; COVID-19

Keywords

SARS-CoV-2; SARS-CoV-2 Vaccine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Safety index-Incidence of adverse reactions

  From the beginning of the vaccination to 28 days after the full course immunization

• Safety index-Incidence of serious adverse events

  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

  28 days after booster dose of immunization

• The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody

  28 days after booster dose of immunization

• The distribution of neutralizing antibody titer

  28 days after 2 dose of immunization and booster dose

Study Arms (4)

Aged 3-6 years old

EXPERIMENTAL

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

Aged 7-12 years old

EXPERIMENTAL

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

Aged 13-17 years old

EXPERIMENTAL

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

Aged ≥18 years old

ACTIVE COMPARATOR

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

Interventions

SARS-CoV-2 Vaccine (Vero Cell), Inactivated BIOLOGICAL

0.5 mL per dose, containing 6.5U inactivated SARS-CoV-2 antigen

Aged 13-17 years old; Aged 3-6 years old; Aged 7-12 years old; Aged ≥18 years old

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• China National Biotec Group Company Limited: lead
• Beijing Institute of Biological Products Co Ltd.: collaborator

Study Sites (1)

Sheikh Khalifa Medical City, SEHA

Abu Dhabi, 51900, United Arab Emirates

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Nawal Al Kaabi, MD

  Sheikh Khalifa Medical City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 8, 2021
• Study Start: July 2, 2021
• Primary Completion: March 31, 2022
• Study Completion: April 29, 2022
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

AE (1)