CovidResearchTrials by Shray Alag


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Two doses of placebo at the emergency vaccination scheduleWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (6)


Name (Synonyms) Correlation
drug866 Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Wiki 1.00
drug867 Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule Wiki 1.00
drug868 Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Wiki 1.00
drug353 Human Biological samples Wiki 1.00
drug869 Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule Wiki 1.00
drug871 Two doses of placebo at the routine vaccination schedule Wiki 1.00

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D045169 Severe Acute Respiratory Syndrome NIH 0.07
D018352 Coronavirus Infections NIH 0.06

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅰ/Ⅱ Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18~59 Years

This study is a randomized, double-blinded, and placebo controlled phase Ⅰ/Ⅱ 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 18~59 Years.

NCT04352608 COVID-19 Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule Biological: Two doses of placebo at the emergency vaccination schedule Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule Biological: Two doses of placebo at the routine vaccination schedule

Primary Outcomes

Description: Occurence of adverse reactions post vaccination

Measure: Safety indexes of adverse reactions

Time: From the beginning of the vaccination to 28 days after the whole schedule vaccination

Description: The seroconversion rates of neutralizing antibodies against 2019 novel coronavirus tested by micro-neutralization assay in serum

Measure: Immunogenicity indexes of neutralizing-antibody seroconversion rates for the emergency vaccination schedule (day 0,14)

Time: The 14th day after two doses of vaccination

Description: The seroconversion rates of neutralizing antibodies against 2019 novel coronavirus tested by micro-neutralization assay in serum

Measure: Immunogenicity indexes of neutralizing-antibody seroconversion rates for the routine vaccination schedule (day 0,28)

Time: The 28th day after two doses of vaccination

Secondary Outcomes

Description: Occurence of adverse reactions post vaccination

Measure: Safety indexes of adverse reactions

Time: 0~7 days after each dose injection

Description: Safety index, abnormal changes will be defined as any one of the lab indexes experiencing changes out of clinical reference value range.

Measure: Occurrence of abnormal changes of laboratory safety examinations (hemoglobin,WBCs, platelets, ALT, AST, total bilirubin, creatinine, creatine phosphokinase, urine protein, urine sugar, urinary erythrocyte)

Time: The 3rd day after each dose injection

Description: Occurence of SAEs post vaccination

Measure: Safety indexes of serious adverse events (SAEs)

Time: From the beginning of the vaccination to 6 months after two doses of vaccination

Description: The seroconversion rates of neutralizing antibodies against 2019 novel coronavirus tested by micro-neutralization assay in serum

Measure: Immunogenicity indexes of neutralizing-antibody seroconversion rates

Time: 7,14,21,42 days after the first dose injection for emergency vaccination schedule and 28,35,42 days after the first dose injection for the routine vaccination schedules

Description: The seropositivity rates of IgG antibody tested by ELISA serum

Measure: Immunogenicity indexes of IgG antibody seropositivity rates

Time: 7,14,21,28, 42 days after the first dose injection for emergency vaccination schedule and 28,35,42,56 days after the first dose injection for the routine vaccination schedule

Description: The seropositivity rates of IgM antibody tested by ELISA serum

Measure: Immunogenicity indexes IgM antibody seropositivity rates

Time: 7,14,21,28, 42 days after the first dose injection for emergency vaccination schedule and 28,35,42,56 days after the first dose injection for the routine vaccination schedule

Description: The GMT of neutralizing antibody against 2019 novel coronavirus tested by micro-neutralization assay in serum

Measure: Immunogenicity indexes of GMT of neutralizing-antibody

Time: 7,14,21,28, 42 days after the first dose injection for emergency vaccination schedule and 28,35,42,56 days after the first dose injection for the routine vaccination schedule

Description: The GMR of neutralizing antibody against 2019 novel coronavirus tested by micro-neutralization assay in serum

Measure: Immunogenicity indexes of GMR of neutralizing-antibody

Time: 7,14,21,28, 42 days after the first dose injection for emergency vaccination schedule and 28,35,42,56 days after the first dose injection for the routine vaccination schedule

Other Outcomes

Description: specific cellular immune responses

Measure: Immunogenicity indexes of cellular immune

Time: The 14th day after each dose vaccination

Description: he seropositivity rates of neutralizing antibodies against 2019 novel coronavirus tested by micro-neutralization assay in serum

Measure: Immunogenicity indexes of neutralizing-antibody persistence

Time: 6 months after two doses of vaccination

Description: The GMT of neutralizing antibody against 2019 novel coronavirus tested by micro-neutralization assay in serum

Measure: Immunogenicity indexes of neutralizing-antibody GMT

Time: 6 months after two doses of vaccination

Description: Seropositivity rates of antinuclear antibody in serum

Measure: Safety indexes-Seropositivity rates of antinuclear antibody

Time: The 7th day after each dose injection

Description: Level of Inflammatory factors in serum

Measure: Safety indexes-Level of Inflammatory factors

Time: The 7th day after each dose injection


No related HPO nodes (Using clinical trials)