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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

NCT05231590 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 581

Last updated 2022-10-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Vaxine Pty Ltd

    collaborator INDUSTRY

  • Cinnagen

    lead INDUSTRY

Principal Investigators

  • Payam Tabarsi, M.D. · Shahid Beheshti University of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-23
Primary Completion
2022-04-14
Completion
2022-09-30

Countries

  • Iran

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05231590 on ClinicalTrials.gov