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Evaluate the Safety and Immunogenicity of Ad5 COVID-19 Vaccines for Booster Use in Children Aged 6-17 Years.

COVID-19 Clinical Trial

Official title:
A Single Center, Open-label, Parallel Controlled, Randomized Phase II Study to Evaluate the Safety and Immunogenicity of Ad5-nCoV-IM, Ad5-nCoV-IH or Inactivated COVID-19 Vaccine in Population 6 to 17 Years of Age

Clinical Trial Summary

This is a single center, open-label, parallel controlled, and randomized Phase II clinical trial to evaluate the safety and immunogenicity of two types of Recombinant Novel Corona Virus Vaccine (Adenovirus type 5 vector) in population aged 6-17 years who have been previously immunized with 2 doses of inactivated COVID-19 vaccine. This is to evaluate the safety and immunogenicity of different heterologous prime-boost regimen in this population.

Clinical Trial Description

Participants will be randomized into two age groups: children aged 6-12 years and adolescents aged 13-17 years. Subjects who have previously been immunized with 2 doses of inactivated COVID-19 vaccine will be randomized into the booster dose groups to receive either 1 dose of 0.1ml inhaled Ad5- nCoV-IH, 1 dose of 0.3ml intramuscular Ad5-nCoV-IM or 1 dose of 0.5ml intramuscular inactivated vaccine ICV as activecomparator in a ratio of 3:1:1. Participants who have not received any COVID-19 vaccine previously will be randomized into 2 primary dose age groups: children aged 6-12 years and adolescents aged 13-17 years to receive 2 doses of 0.1ml inhaled Ad5-nCoVIH. The first 5 subjects of each age group will enter the sentinel group to receive Ad5-nCoV-IH and monitor for safety before the rest of the enrollment process. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05330871
Study type Interventional
Source Seventh Medical Center of PLA General Hospital
Contact
Status Active, not recruiting
Phase Phase 2
Start date April 17, 2022
Completion date May 30, 2023
View Details
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