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Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836

NCT06582277 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2025-06-06

No results posted yet for this study

Summary

This phase 2a is designed to evaluate the anamnestic response of a booster dose (either 180 µg or 480 µg) of OVX836 influenza vaccine administered intramuscularly to participants vaccinated three to five years ago in OVX836-002 or OVX836-003 studies. Participants who had received a placebo or Influvac Tetra® in previous studies would serve as controls and would receive the highest dose of OVX836 vaccine (480 µg) as a primary vaccination.

Conditions

Interventions

BIOLOGICAL

OVX836 shot

One single administration intramuscularly at Day 1.

Sponsors & Collaborators

  • Harmony Clinical Research BVBA

    collaborator OTHER

  • Clinfidence

    collaborator UNKNOWN

  • Inferential

    collaborator INDUSTRY

  • University Hospital, Ghent

    collaborator OTHER

  • KCAS Bio

    collaborator UNKNOWN

  • Osivax

    lead INDUSTRY

Principal Investigators

  • Nicola Groth, MD · Osivax

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-22
Primary Completion
2025-06-02
Completion
2025-06-02

Countries

  • Belgium

Study Locations

More Related Trials

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 NCT06582277 on ClinicalTrials.gov