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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Sinovac Research and Development Co., Ltd.
- Enrollment
- 1040
- Locations
- 1
- Primary Endpoint
- Immunogenicity index-geometric mean titer(GMT) of neutralizing antibody
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Detailed Description
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. The experimental vaccine was manufactured by Sinovac Research \& Development Co.,Ltd. Totally 1040 subjects，including: 130 subjects aged 18\~25 years; 520 subjects aged 26\~45 years, with 260 in each group; 130 subjects aged 46\~59 years; 260 subjects aged ≥60 years. Subjects will be assigned to receive two doses of medium-dosage vaccine on the schedule of 0,14.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy adults aged 18-59 or elderly aged ≥60 years;
- •Proven legal identity.
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Immunogenicity index-geometric mean titer(GMT) of neutralizing antibody
Time Frame: Day 14 after the full course vaccination
Neutralizing antibody assay will be performed using the micro-neutralization method
Secondary Outcomes
- 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)
- 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)