MedTrace Logo

Immunogenicity and Safety of the Concomitant Administration of OVX836 and Quadrivalent Influenza Vaccine in Healthy Volunteers.

NCT05284799 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-10-31

No results posted yet for this study

Summary

The present study will evaluate the concomitant administration of a Quadrivalent Inactivated Influenza Vaccine with the highest dose level of OVX836 (480µg) tested in the clinic to date, for which the likelihood for interference with Quadrivalent Inactivated Influenza Vaccine is considered the highest.

Conditions

Interventions

BIOLOGICAL

OVX836 480µg

One single administration intramuscularly at Day 1

BIOLOGICAL

Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra)

One single administration intramuscularly at Day 1

BIOLOGICAL

Placebo

One single administration intramuscularly at Day 1

Sponsors & Collaborators

  • Northern Beaches Clinical Research

    collaborator UNKNOWN

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Harmony Clinical Research BVBA

    collaborator OTHER

  • Osivax

    lead INDUSTRY

Principal Investigators

  • Ross Aldrich, MBBS · Northern Beaches Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-09
Primary Completion
2022-07-19
Completion
2022-12-09

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
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 NCT05284799 on ClinicalTrials.gov