Name (Synonyms) | Correlation | |
---|---|---|
drug2578 | Two doses of placebo at the schedule of day 0,28 Wiki | 1.00 |
drug2572 | Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Wiki | 1.00 |
drug2575 | Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Wiki | 1.00 |
Name (Synonyms) | Correlation | |
---|---|---|
D007410 | Intestinal Diseases NIH | 1.00 |
D015212 | Inflammatory Bowel Diseases NIH | 0.50 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
D018352 | Coronavirus Infections NIH | 0.04 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002242 | Abnormal intestine morphology HPO | 1.00 |
HP:0002037 | Inflammation of the large intestine HPO | 0.50 |
There is one clinical trial.
This study is a randomized, double-blinded, and placebo controlled phase 1&2 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults aged≥60 years.
Description: Incidence of adverse reactions after each dose vaccination
Measure: Safety index-incidence of adverse reactions Time: Day 0-28 after each dose vaccinationDescription: Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or ≥4 fold increase from baseline.
Measure: Immunogenicity index-seroconversion rates of neutralizing antibody Time: The 30th day after the second dose vaccinationDescription: SAE will be collected throughout the clinical trial
Measure: Safety index-incidence of serious adverse events Time: From the beginning of the vaccination to 12 months after the second dose vaccinationDescription: Neutralizing antibody assay will be performed using the micro-neutralization method, and subjects with a antibody titer ≥1:8 will defined as seropositive.
Measure: Immunogenicity index-seropositive rates of neutralizing antibody Time: The 30th day and the 12 month after the second dose vaccinationDescription: Neutralizing antibody assay will be performed using the micro-neutralization method
Measure: Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody Time: The 30th day and the 12 month after the second dose vaccinationDescription: Neutralizing antibody assay will be performed using the micro-neutralization method. Ratio of post-vaccination titer divided by baseline titer will be calculated.
Measure: Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody Time: The 30th day after the second dose vaccination