NCT06234956

Open-label, Multi-centre, Non-Inferiority Study of Safety and Immunogenicity of BIMERVAX for the Prevention of COVID-19 in Adolescents From 12 Years to Less Than 18 Years of Age.

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Hipra Scientific, S.L.U · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This is a Phase IIb, open-label, uncontrolled, multi-centre, non-inferiority clinical trial, to assess the safety and immunogenicity of BIMERVAX® as a heterologous booster dose in adolescents. In this study a total of 300 adolescents from 12 to less than 18 years will be enrolled and followed for 12 months.

Conditions

• SARS CoV 2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	BIMERVAX	BIMERVAX

Timeline

• Start date: 2023-06-08
• Primary completion: 2025-09-09
• Completion: 2025-09-09
• First posted: 2024-01-31
• Last updated: 2026-03-12

Locations

7 sites across 1 country: Spain