NCT05231590

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

A Non-Randomized, Three-Armed, Open-Label, Parallel-Group, Non-Inferiority Trial to Compare the Immunogenicity and Safety of an Adjuvanted Recombinant Spike Protein COVID-19 Vaccine (SpikoGen) in Children Aged 5 to <12 Years and 12 to <18 Years With Adults Aged 18 to 40 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 581 (actual)
• Sponsor: Cinnagen · Industry
• Sex: All
• Age: 5 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Low-dose SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant	SARS-CoV-2 recombinant spike protein (12.5 µg) with Advax-SM adjuvant (7.5 mg) in two doses with a 21-day interval administered with intramuscular injections in the non-dominant arm
BIOLOGICAL	SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant	SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg) in two doses with a 21-day interval administered with intramuscular injections in the non-dominant arm

Timeline

• Start date: 2022-02-23
• Primary completion: 2022-04-14
• Completion: 2022-09-30
• First posted: 2022-02-09
• Last updated: 2022-10-17

Locations

1 site across 1 country: Iran