Study of the Commercial Scale SARS-CoV-2 Vaccine Against the Pilot Scale Among Adults, and Bridging Study of the Immunogenicity in Elderly Against That in Adults

NCT04617483 | Completed Phase 3 DMC

• 1 other identifier: PRO-nCOV-3001
• Study Type: interventional
• Target: 1,040
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blinded clinical Trial, to evaluate the non-inferiority of the commercial scale Inactivated SARS-CoV-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Immunogenicity index-geometric mean titer(GMT) of neutralizing antibody

  Neutralizing antibody assay will be performed using the micro-neutralization method

  Day 14 after the full course vaccination

Secondary Outcomes (4)

• Immunogenicity index-Seroconversion rate of the neutralizing antibody

  Day 14 after the full course vaccination

• Immunogenicity index-Seropositive rate of the neutralizing antibody

  Day 14 after the full course vaccination

• Safety index-Incidence of adverse reactions

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

• Safety index-Incidence of serious adverse events

  From the beginning of the vaccination to 6 months after the full course vaccination

Study Arms (3)

Aged 26-45, Commercial Scale

EXPERIMENTAL

Commercial scale inactivated SARS-CoV-2 vaccine in adults aged 26-45 years.

Biological: Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14

Aged 18-59, Pilot Scale

EXPERIMENTAL

Pilot scale inactivated SARS-CoV-2 vaccine in adults aged 18-59 years.

Biological: Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14

Aged ≥60, Pilot Scale

EXPERIMENTAL

Pilot scale inactivated SARS-CoV-2 vaccine in elderly aged above 60 years.

Biological: Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly

Interventions

Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 BIOLOGICAL

The antigen content of the commercial scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 26-45.

Aged 26-45, Commercial Scale

Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 BIOLOGICAL

The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 18-59.

Aged 18-59, Pilot Scale

Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly BIOLOGICAL

The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group above 60.

Aged ≥60, Pilot Scale

Eligibility Criteria

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

You may qualify if:

• Healthy adults aged 18-59 or elderly aged ≥60 years;
• Proven legal identity.

You may not qualify if:

• Travel/residence history of communities with reported cases within 14 days before trial;
• History of exposure to Novel Coronavirus infection (nucleic acid positive) within 14 days prior to the trial;
• Exposed to patients with fever or respiratory symptoms from communities with reported cases within 14 days prior to the trial;
• 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;
• History of SARS-CoV-2 infection;
• History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema;
• Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
• Autoimmune disease or immunodeficiency/immunosuppression;
• Patients with serious chronic diseases, serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc.;
• Serious neurological disorder (epilepsy, convulsions or convulsions) or psychosis;
• History of thyroid disease or thyroidectomy, absence of spleen, functional absence of spleen, and absence of spleen or splenectomy caused by any circumstance;
• Coagulation dysfunction (such as coagulation factor deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder diagnosed by doctors;
• Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis) in the past 6 months;
• Long history of alcohol or drug abuse;
• Received blood products within 3 months prior to receiving the vaccine;

Sponsors & Collaborators

• Sinovac Research and Development Co., Ltd.: lead

Study Sites (1)

Dafeng District Center for Disease Prevention and Control

Yancheng, Jiangsu, 224100, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

Aging

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)

Growth and Development; Physiological Phenomena

Study Officials

• Hongxing Pan, Master

  Jiangsu Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The first part of the study is a double-blinded trial, the second part is a open-label research.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 5, 2020
• Study Start: October 31, 2020
• Primary Completion: November 28, 2020
• Study Completion: May 31, 2021
• Last Updated: July 27, 2021

Record last verified: 2020-11

Locations

CN (1)