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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.

NCT06234956 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2026-03-12

No results posted yet for this study

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

BIOLOGICAL

BIMERVAX

BIMERVAX

Sponsors & Collaborators

  • Veristat, Inc.

    collaborator OTHER

  • VHIR

    collaborator UNKNOWN

  • Asphalion

    collaborator UNKNOWN

  • Hipra Scientific, S.L.U

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-08
Primary Completion
2025-09-09
Completion
2025-09-09

Countries

  • Spain

Study Locations

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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 NCT06234956 on ClinicalTrials.gov