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

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.

Timeline

Start

2022-04-17

Primary completion

2022-06-30

Completion

2023-05-30

Publications

• Huang T, Zhang S, Dai DF, Wang BS, Zhuang L, Huang HT, Wang ZF, Zhao JS, Li QP, Wu SP, Wang X, Zhang WD, Zhao ZH, Li H, Zhang YP, Yang XL, Jiang XY, Gou JB, Hou LH, Gao LD, Feng ZC. Safety and immunogenicity of heterologous boosting with orally aerosolised or intramuscular Ad5-nCoV vaccine and homologous boosting with inactivated vaccines (BBIBP-CorV or CoronaVac) in children and adolescents: a randomised, open-label, parallel-controlled, non-inferiority, single-centre study. Lancet Respir Med. 2023 Aug;11(8):698-708. doi: 10.1016/S2213-2600(23)00129-7. Epub 2023 May 17.

Drugs

Indications