Open-label, Multi-centre, Non-Inferiority study of safety and immunogenicity of BIMERVAX as heterologous booster for the prevention of coronavirus disease 2019 (COVID-19) in adolescents from 12 years to less than 18 years of age.

Conditions

SARS-CoV-2 infection

Brief summary

Neutralisation titre against Omicron BA.1 measured as inhibitory concentration 50 (IC50) by PBNA and reported as log10 concentration for each individual sample and Geometric Mean Titre (GMT) for group comparison with HIPRA-HH-2 at Baseline and Day 14., Solicited local and systemic reactions through Day 7 after vaccination., Unsolicited local and systemic adverse events (AEs) through Day 28 after vaccination., Related adverse events (AEs) and all serious adverse events (SAEs) through the end of the study., Adverse event of special interest (AESI) through the end of the study., Related medically attended adverse events (MAAE) through the end of the study., Grade 2, Grade 3 and Grade 4 changes from Baseline in safety laboratory parameters through Day 14 after vaccination.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGBIMERVAX emulsion for injection COVID-19 Vaccine (recombinant

DRUGadjuvanted)

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Neutralisation titre against Omicron BA.1 measured as inhibitory concentration 50 (IC50) by PBNA and reported as log10 concentration for each individual sample and Geometric Mean Titre (GMT) for group comparison with HIPRA-HH-2 at Baseline and Day 14., Solicited local and systemic reactions through Day 7 after vaccination., Unsolicited local and systemic adverse events (AEs) through Day 28 after vaccination., Related adverse events (AEs) and all serious adverse events (SAEs) through the end of the study., Adverse event of special interest (AESI) through the end of the study., Related medically attended adverse events (MAAE) through the end of the study., Grade 2, Grade 3 and Grade 4 changes from Baseline in safety laboratory parameters through Day 14 after vaccination.	—

Measure

Time frame

Neutralisation titre against Omicron BA.1 measured as inhibitory concentration 50 (IC50) by PBNA and reported as log10 concentration for each individual sample and Geometric Mean Titre (GMT) for group comparison with HIPRA-HH-2 at Baseline and Day 14., Solicited local and systemic reactions through Day 7 after vaccination., Unsolicited local and systemic adverse events (AEs) through Day 28 after vaccination., Related adverse events (AEs) and all serious adverse events (SAEs) through the end of the study., Adverse event of special interest (AESI) through the end of the study., Related medically attended adverse events (MAAE) through the end of the study., Grade 2, Grade 3 and Grade 4 changes from Baseline in safety laboratory parameters through Day 14 after vaccination.

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Countries

Spain

Outcome results

None listed