drugset / Trial / NCT04550351

Recombinant New Coronavirus Vaccine (CHO Cells) to Prevent SARS-CoV-2 Phase I Clinical Trial (≥60 Years Old)

NCT04550351 ↗

RandomizedSequentialQuadruple-blindPrevention

Summary

Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Secondary purpose: to initially explore the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells). Overall design: A single-center, randomized, double-blind, placebo-controlled trial design was adopted. Study population: a healthy population of 60 years and above, a total of 50 cases, both men and women. Test groups: 20 cases in the low-dose group, 5 cases in the placebo group; 20 cases in the high-dose group, 5 cases in the placebo group.

Timeline

Start
2020-08-19
Primary completion
2020-12-18
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant new coronavirus vaccine (CHO cell) Vaccine 25 ug Intramuscular
Subject Recombinant new coronavirus vaccine (CHO cell) Vaccine 50 ug Intramuscular

Indications