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 | Biotech Hunter

Enrollment

581

Participants

Timeline

Start Date

February 23, 2022

Primary Completion Date

April 14, 2022

Study Completion Date

September 30, 2022

Conditions

COVID-19

Interventions

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

Trial Locations (1)

Unknown

Orchid Life Department, Orchid Pharmed Company, Tehran