Immunogenicity and Safety of Three Dose Levels of OVX836 Candidate Vaccine Against Influenza in Healthy Volunteers.

NCT05060887 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2023-08-31

No results posted yet for this study

Summary

This Phase 2a clinical trial is designed to evaluate the immunogenicity and the safety of one administration of OVX836 influenza vaccine at different dose levels (180µg, 300μg and 480μg) in order to assess the dose response of the OVX836 influenza vaccine.

Conditions

Interventions

BIOLOGICAL

OVX836-003

One single administration intramuscularly at Day 1.

BIOLOGICAL

Saline solution

One single administration intramuscularly at Day 1.

Sponsors & Collaborators

  • Center for vaccinology (CEVAC), University of Ghent

    collaborator UNKNOWN
  • Osivax

    lead INDUSTRY

Principal Investigators

  • Isabel Leroux-Roels, MD, PhD · Centre for Vaccinology (CEVAC), Ghent University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-02-01
Completion
2022-12-07

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 NCT05060887 on ClinicalTrials.gov