Phase 2a, single center, randomized, double-blind, controlled study to evaluate the immunogenicity and the safety of one single administration of OVX836 influenza vaccine at two dose levels (300µg and 480µg) given intramuscularly (IM), in comparison to OVX836 influenza vaccine at 180µg and placebo given IM in healthy subjects aged 18-55 years and in healthy subjects aged 65 years and older. - OVX836-003

Osivax0 sites238 target enrollmentSeptember 6, 2021

ConditionsThe study is being conducted in healthy volunteers for the prophylaxis of influenza infection.MedDRA version: 21.1Level: PTClassification code 10059429Term: Influenza immunisationSystem Organ Class: 10042613 - Surgical and medical procedures Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: The study is being conducted in healthy volunteers for the prophylaxis of influenza infection.
Sponsor: Osivax
Enrollment: 238
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 6, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Osivax

Eligibility Criteria

Inclusion Criteria

•1\.Written informed consent.
•2\.Healthy male or female subjects, as determined by medical history and medical examination.
•3\.Between the ages of 18 and 55 years, inclusive, in the pilot phase and the first, younger age cohort; aged 65 years and older in the second, older age cohort.
•4\.Subject who has fully been vaccinated with licensed SARS\-CoV\-2 (COVID\-19\) vaccine(s) according to national recommendations for the corresponding population group.
•5\.Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures.
•6\.Ability and technical possibility for completing an e\-diary and e\-PRO in the pilot phase and the first, younger age cohort; ability for completing a paper diary in the second, older age cohort.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 138

Exclusion Criteria

•1\.Subjects with a body mass index (BMI) \=19 kg/m² or \=35 kg/m² on the day of vaccination
•2\.In the pilot phase and the first younger age cohort only: Previous influenza vaccination within 6 months before the day of vaccination or planned to receive during the study duration.
•3\.Any known or suspected immunodeficient conditions.
•4\.Past or current history of significant autoimmune diseases, as judged by the Investigator.
•5\.Current history of uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases.
•6\.Known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
•7\.Female subjects: pregnant, breast\-feeding or of childbearing potential without appropriate contraceptive methods in place for 2 months before enrolment, or with positive pregnancy test on the day of vaccination. Appropriate contraceptive methods are to be maintained until the end of the trial.
•8\.Having received another vaccination within 3 months prior to the day of study vaccination for live attenuated vaccines, or within 1 month prior to the day of study vaccination for inactivated vaccines, except COVID\-19 vaccine.
•9\.Planning to receive other vaccines during the first 28 days following the study vaccine administration, except COVID\-19 vaccine.
•10\.Administration of any investigational or non\-registered drug or vaccine within 3 months prior to the administration of study vaccines, or planned administration of any such product during the whole study period.