Immunogenicity and Safety of the SpikoGen COVID-19 Vaccine in Children Aged 5 to <12 Years and 12 to <18 Years Compared With Adults Aged 18 to 40 Years

Summary

This was a non-randomized, three-armed, open-label, parallel-group, non-inferiority trial designed to compare the immunogenicity and safety of the SpikoGen COVID-19 vaccine in children aged 5 to \<12 years and 12 to \<18 years with adults aged 18 to 40 years. Children aged 12 to \<18 years and adults received 25 µg of the recombinant protein together with 15 mg of Advax-SM. Children aged 5 to \<12 years received a half-dose of the adjuvanted vaccine. The injection was given in two doses with a 21-day interval in the deltoid muscle of the non-dominant arm. The vaccine immunogenicity was evaluated at 14 days after the second dose. Solicited adverse events were recorded for 7 days after each vaccination. Unsolicited adverse events were collected through one month after the second dose. Safety monitoring was continued through six months after the second dose in children aged 5 to \<12 years and 12 to \<18 years.

Timeline

Start

2022-02-23

Primary completion

2022-04-14

Completion

2022-09-30

Drugs

Indications