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Safety and Immune Response of One Dose of OVX836 at Two Dose Levels, in Comparison to Influvac TetraTM, After Intramuscular Administration in Healthy Subjects Aged 18-65 Years

NCT04192500 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-09-22

No results posted yet for this study

Summary

This Phase 2a clinical study is designed to evaluate the immunogenicity and the safety of one dose of OVX836 influenza vaccine administered IM, confirm the dose level and regimen, and expand immunogenicity and safety data to adults through age 65.

Conditions

Interventions

BIOLOGICAL

OVX836

One single administration intramuscularly at Day 1.

BIOLOGICAL

Quadrivalent seasonal influenza vaccine (Influvac TetraTM)

One single administration intramuscularly at Day 1.

Sponsors & Collaborators

  • Centre 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
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-11
Primary Completion
2020-09-07
Completion
2020-09-07
FDA Drug
Yes

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 NCT04192500 on ClinicalTrials.gov