NCT05517642

IH Convidecia as Second Booster Dose Against Breakthrough Infections

Immunogenicity, Efficacy and Safety of Inhaled (IH) Viral Vectored Vaccine (Convidecia, CanSino) as Second Booster Dose Against Emerging Variants of Concern (VOC) of SARS-CoV-2 to Prevent Breakthrough Infections. A Randomized Observer-blind Controlled Trial.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This will be a randomized single-blind controlled trial to determine the immunogenicity, efficacy and safety of IH Convidecia (CanSino), as a second booster vaccination against Omicron and other emerging VOCs to prevent breakthrough infections among people with a sub-optimal immune response to the first booster dose. These subjects will be randomized in a ratio of 1:1 to receive a second booster dose of IH Convidecia vaccine (treatment arm), or a second booster dose of mRNA vaccine BNT162b2 (Pfizer).

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)	Subjects will be randomized to receive a second booster dose of IH Convidecia vaccine (treatment arm)
BIOLOGICAL	mRNA vaccine BNT162b2 (Pfizer)	Subjects will be randomized to receive a second booster dose of BNT162b2.

Timeline

• Start date: 2022-09-20
• Primary completion: 2023-05-02
• Completion: 2023-05-02
• First posted: 2022-08-26
• Last updated: 2023-09-08

Locations

1 site across 1 country: Malaysia