NCT05169008

A Study to Evaluate the Safety and Immunogenicity of Ad5-nCoV and Ad5-nCoV-IH in CoronaVac Immunized Children and Adolescents

A Multicenter, Randomized, and Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of Intramuscular and Inhaled COVID-19 Vaccine in Children Aged 6-12 Years and Adolescents Aged 13-17 Years Who Have Been Immunized With Two Doses of CoronaVac

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter, randomized, and open-label study to evaluate the immune responses and safety profiles of children aged 6-12 years and adolescents aged 13-17 years receiving Ad5-nCoV (intramuscular injection) or Ad5-nCoV-IH (nebulized inhalation) ≥ 90 days after receiving two doses of CoronaVac.

Detailed description

A total of 1000 participants will be equally divided into the two study groups, children of 6-12 years and adolescents of 13-17 years. In each age group, they will have an equal chance to received either one dose of Ad5-nCoV (intramuscular injection) or Ad5-nCoV-IH (nebulized inhalation). The enrollment of the children group will start after the safety profiles in 7 days post-vaccination of the adolescent group have been deemed acceptable. Investigators should try to balance the age and sex of the participants during enrollment.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)	Intramuscular injection
BIOLOGICAL	Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)	Nebulized inhalation through the mouth

Timeline

• Start date: 2022-02-25
• Primary completion: 2023-01-13
• Completion: 2023-01-13
• First posted: 2021-12-23
• Last updated: 2023-06-15

Locations

2 sites across 1 country: Chile