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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
581
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
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
Orchid Life Department, Orchid Pharmed Company
Tehran, Iran
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies
As measured by virus neutralization test; the primary aim of this study was to establish non-inferiority of the immunogenicity of SpikoGen COVID-19 vaccine in children aged 5 to \<12 to that in adults
Time frame: 14 days after the second dose
Incidence of solicited adverse events
Injection site pain, erythema, swelling, and induration, axillary swelling or tenderness ipsilateral to the side of injection, fever (oral temperature), headache, fatigue, myalgia, arthralgia, nausea, vomiting, and chills, as reported by the study participants on electronic diaries, and as defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)
Time frame: For 7 days after each dose
Incidence of unsolicited adverse events
As reported by the study participants on electronic diaries, and as defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)
Time frame: Up to 1 month after the second dose
Incidence of serious adverse events (SAEs) and suspected unexpected serious adverse reaction (SUSARs) in children
As defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA)
Time frame: Up to 6 months after the second dose
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies
As measured by ELISA
Time frame: 14 days after the second dose
Percentage of participants with seroconversion for S1 binding IgG antibodies
As measured by ELISA
Time frame: 14 days after the second dose
Geometric mean ratio (GMR) for S1 binding IgG antibodies
As measured by ELISA
Time frame: 14 days after the second dose
Geometric mean titer (GMT) for SARS-CoV-2 neutralizing antibodies
As measured by virus neutralization test
Time frame: 14 days after the second dose
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies
As measured by virus neutralization test
Time frame: 14 days after the second dose
Geometric mean ratio (GMR) for SARS-CoV-2 neutralizing antibodies
As measured by virus neutralization test
Time frame: 14 days after the second dose
Geometric mean concentration (GMC) for S1 binding IgG antibodies
As measured by ELISA
Time frame: 14 days after the second dose
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