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Clinical Trials/2024-520354-37-00
2024-520354-37-00
Not yet recruiting
Phase 2

Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, immunogenicity and safety of one dose of OVX836 influenza vaccine 480μg, after intramuscular administration in healthy subjects aged 18-59 years

Osivax9 sites in 4 countries2,850 target enrollmentStarted: June 4, 2025Last updated:
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Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Osivax
Enrollment
2,850
Locations
9
Primary Endpoint
First occurrence of RT-PCR-confirmed influenza Type A illness, from 14 days after vaccination, characterized by the presence of one or more of the following respiratory symptoms (sore throat, cough, sputum production, wheezing, difficulty breathing), concurrent with one or more of the following systemic symptoms (temperature ≥37.5°C, chills, tiredness, headache or myalgia), lasting for at least 24 hours.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To evaluate the efficacy following a vaccination with OVX836 influenza vaccine (480μg) in preventing RT-PCR-confirmed influenza Type A clinical disease (protocol-defined ILI), in comparison to placebo.

Study Design

Allocation
Not Applicable
Primary Purpose
Last phone contact
Masking
None

Eligibility Criteria

Ages
18 years to 64 years (18-64 Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Written informed consent
  • •Healthy male or female subjects, as determined by medical history and medical examination.
  • •Between the ages of 18 and 59 years, inclusive
  • •Subjects compliant with the reproductive criteria for male and female participants
  • •Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures
  • •Able to read, understand, and complete an eDiary and electronic patient-reported outcome (ePRO)
  • •Subject socially active: living in a family with children or with other house-hold members, having frequent social contacts at university, work, in public places such as restaurants, theaters, public transportation, etc.
  • •Able to read and sign the subject information sheet and informed consent form (ICF).

Exclusion Criteria

  • •Previous vaccination with an authorized or experimental seasonal, zoonotic or pandemic influenza vaccine within 6 months before the day of vaccination or planned to receive it during the whole study period
  • •Past or current history of significant autoimmune diseases, as judged by the Investigator
  • •Known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
  • •Any medical illness such as diabetes, hypertension, heart, renal, or hepatic diseases, as judged by the Investigator
  • •Planned absences without access to the investigational site, i.e. vacation or business trips, for more than 7 consecutive days during the study period
  • •Pregnant or lactating woman
  • •Having received another vaccine within 1 month prior to the day of study vaccination, except COVID-19 vaccines for which the minimum time period should be two weeks prior to study vaccination
  • •Planning to receive any other vaccines during the first 28 days following the study vaccine administration, except COVID-19 vaccines which can be administered from 14 days following the study vaccine administration
  • •Administration of any investigational or non-registered drug or vaccine within 1 month prior to the administration of study vaccines, or planned administration of any such product during the whole study period
  • •History of receiving blood, blood components, or immunoglobulins within 3 months prior to the day of vaccination, or planned to receive such product during the whole study period.

Outcomes

Primary Outcomes

First occurrence of RT-PCR-confirmed influenza Type A illness, from 14 days after vaccination, characterized by the presence of one or more of the following respiratory symptoms (sore throat, cough, sputum production, wheezing, difficulty breathing), concurrent with one or more of the following systemic symptoms (temperature ≥37.5°C, chills, tiredness, headache or myalgia), lasting for at least 24 hours.

First occurrence of RT-PCR-confirmed influenza Type A illness, from 14 days after vaccination, characterized by the presence of one or more of the following respiratory symptoms (sore throat, cough, sputum production, wheezing, difficulty breathing), concurrent with one or more of the following systemic symptoms (temperature ≥37.5°C, chills, tiredness, headache or myalgia), lasting for at least 24 hours.

Secondary Outcomes

  • First occurrence of laboratory-confirmed (RT-PCR-confirmed cases and in RT-PCR + culture-confirmed cases) influenza Type A symptomatic illness, from 14 days after vaccination, corresponding to other clinical definitions of the ILI (e.g., Centers for Disease Control and Prevention’s [CDC] definition [modified or not]).
  • Subtype of virus in laboratory-confirmed (RT-PCR-confirmed cases and in RT-PCR + culture-confirmed cases) influenza Type A cases, from 14 days after vaccination.
  • First occurrence of laboratory-confirmed (RT-PCR-confirmed cases and in RT-PCR + culture-confirmed cases) influenza symptomatic disease irrespective of strain/type, from 14 days after vaccination.
  • First occurrence of laboratory-confirmed (RT-PCR-confirmed cases and in RT-PCR + culture-confirmed cases) influenza Type B symptomatic disease, from 14 days after vaccination.
  • First occurrence of any ILIs irrespective of causal agent (confirmed or not by laboratory [RT-PCR-confirmed cases and in RT-PCR + culture-confirmed cases]), from 14 days after vaccination.
  • Severity (mean and maximum grading of symptoms) and duration of ILI episodes, with a trapezoidal calculation of the area under the curve [AUC] of the daily scores on the Flu-PRO® questionnaire, by treatment group (OVX836 and placebo).
  • SF-12 HRQoL physical and mental components scores changes between baseline (Day 1) and 14 days after each ILI episode start date, by treatment group (OVX836 and placebo).
  • Mean and maximum EQ-5D-5L HRQoL scores and trapezoidal calculation of the AUC of the daily scores, by treatment group (OVX836 and placebo).
  • Mean and maximum EQ-5D-L HRQoL visual analog scale (VAS) score and trapezoidal calculation of the AUC of the daily scores, by treatment group (OVX836 and placebo).
  • Composite endpoint taking into account Flu-PRO® AUC, SF-12 change versus baseline and EQ-5D AUCs.
  • Occurrence of solicited local and systemic signs and symptoms during 7 days after vaccine administration
  • Occurrence of unsolicited AEs during 29 days after vaccine administration.
  • Occurrence of SAEs/AESI/NOCD/MAAEs during the whole study period.
  • CMI response to OVX836 (480μg) in terms of NP-specific T-cell (number of spot-forming cells [SFC] per million PBMCs), measured by IFNγ ELISPOT, at Day 1 and Day 8, in a limited subset of 56 subjects (28 placebo and 28 OVX836 recipients).
  • Percentage of NP specific CD4+ and CD8+ T-cell measured by flow cytometry on PBMCs as expressing cytokines, e.g. IFNγ, IL-2 and TNFα, at pre-injection baseline (Day 1) and at Day 8, in a limited subset of 56 subjects (28 placebo and 28 OVX836 recipients)
  • Anti-NP IgG measured by Enzyme Linked Immunosorbent Assay (ELISA) at pre-injection baseline (Day 1) and at Day 8, in a limited subset of 56 subjects (28 placebo and 28 OVX836 recipients).
  • The analyses of the primary and secondary efficacy endpoints will be replicated irrespectively of the time between vaccination and cases occurrence

Investigators

Sponsor
Osivax
Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Linda Lebon

Scientific

Osivax

Study Sites (9)

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