MedTrace Logo

Immunogenicity and Safety of the Concomitant Administration of OVX836 Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccines and Placebo in Healthy Subjects.

NCT05734040 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2024-01-25

No results posted yet for this study

Summary

The present study OVX836-006 aims principally to:

* Confirm feasibility of the concomitant administration of the vaccines under normal clinical conditions, i.e. as two separate concomitant injections into opposite arms;
* Introduce an additional representative brand of Quadrivalent Inactivated Influenza Vaccines ;
* Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the Hemagglutinin response;
* Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the nucleoprotein response;
* Evaluate the absolute vaccine efficacy of OVX836 compared to placebo in order to corroborate the efficacy signals previously detected in the OVX836 previous studies;
* Evaluate the combined vaccine efficacy of OVX836 + Quadrivalent Inactivated Influenza Vaccines versus OVX836 + placebo, and versus double placebo.

Conditions

Interventions

BIOLOGICAL

OVX836 480µg

One single administration intramuscularly at Day 1

BIOLOGICAL

Fluarix Tetra

One single administration intramuscularly at Day 1

BIOLOGICAL

Afluria Quad

One single administration intramuscularly at Day 1

BIOLOGICAL

Placebo

One single administration intramuscularly at Day 1

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Mater Misericordiae Limited

    collaborator UNKNOWN

  • Osivax

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2023-08-10
Completion
2024-01-15

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 NCT05734040 on ClinicalTrials.gov