CanSino Biologics Inc.
This phase III clinical trial is an endpoint-driven randomized, double-blind, parallel-controlled, multicenter clinical trial, and around 13,000 subjects aged 18 years and above who have previously received 1 dose of intramuscular Ad5-nCoV will be recruited. Volunteers should have been vaccinated with intramuscular Ad5-nCoV > 56 days prior to enrollment. All subjects will receive 1 dose of investigational vaccine or placebo through nebulized inhalation. The ratio of subjects in the vaccine group and placebo group is 1:1 and the efficacy and safety of the investigational vaccine will be followed up for 52 weeks after vaccination.
COVID-19
Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)
Placebo
Phase 3
Study Type : | Interventional |
Estimated Enrollment : | 0 participants |
Masking : | Quadruple |
Primary Purpose : | Prevention |
Official Title : | A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial on the Efficacy, Safety, and Immunogenicity of Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation (Ad5-nCoV-IH) in Adults Aged 18 Years and Above Who Have Received One Dose of Intramuscular Ad5-nCoV |
Actual Study Start Date : | December 15, 2021 |
Estimated Primary Completion Date : | April 15, 2022 |
Estimated Study Completion Date : | August 20, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Experimental group 6500 participants, Ad5-nCoV-IH, single dose, nebulized inhalation |
Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH) |
Placebo Comparator: Placebo group 6500 participants, placebo, single dose, nebulized inhalation |
Biological: Placebo |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.