Status:
COMPLETED
Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836
Lead Sponsor:
Osivax
Collaborating Sponsors:
Harmony Clinical Research BVBA
Clinfidence
Conditions:
Vaccine-Preventable Diseases
Influenza
Eligibility:
All Genders
20-64 years
Phase:
PHASE2
Brief Summary
This phase 2a is designed to evaluate the anamnestic response of a booster dose (either 180 µg or 480 µg) of OVX836 influenza vaccine administered intramuscularly to participants vaccinated three to f...
Detailed Description
This is a phase 2a, single center, randomized, double-blind study designed to evaluate the immunogenicity and safety of one single administration of OVX836 influenza vaccine at two dose levels (180μg ...
Eligibility Criteria
Inclusion
- Subject who voluntarily provides written informed consent to participate in the study.
- Healthy male or female subjects, as determined by medical history and medical examination
- Subject compliant with the reproductive criteria for female participants
- Subjects who participated in the OVX836-002 or OVX836-003 studies.
- Subjects aged 20 and 64 years, inclusive.
- Reliable and willing to commit to participating for the duration of the study, and capable of following study procedures diligently.
- Ability and technical capability to complete an eDiary.
Exclusion
- Subjects with a body mass index (BMI) ≤18 kg/m² or ≥35 kg/m² on the day of vaccination.
- Previous influenza vaccination within 6 months before the day of vaccination or planned to receive during the whole study period.
- vaccination with an mRNA-based influenza vaccine including NP in its composition.
- Any known or suspected immunodeficient conditions.
- Past or current history of significant autoimmune diseases, as judged by the Investigator.
- Current history of uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases.
- Known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
- Pregnant or lactating woman.
- Female planning to become pregnant or planning to discontinue contraceptive precautions until the end of the trial.
- Participants with extensive tattoos covering deltoid regions on both arms that would preclude the assessment of local reactogenicity.
- Other 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 non-live vaccines, at the exception of COVID vaccines which can be administered within 14 days before or after study vaccine administration.
- Planning to receive other vaccines during the first 28 days following the study vaccine administration.
- 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 entire 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.
- Presence of an acute febrile illness on the day of vaccination (oral temperature \>38.0°C, temporary exclusion criterion).
- Past or current history of any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
- Behavioral or cognitive impairment, or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study.
- History of alcohol or drug abuse that ceased less than 6 months before enrolment, current alcohol or drug abuse according to the Investigator's judgement), smoking habit of more than 10 cigarettes/day, or current vaping (nicotine consumption corresponding to more than 10 cigarettes/day).
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months before the study vaccine administration. For corticosteroids, this will mean prednisone equivalent ≥20 mg/day. Inhaled, topical and intra-articular steroids are allowed.
- Current or past malignancy, unless completely resolved for \>5 years (except non-metastatic basal cell carcinoma which has been completely resected).
- History of severe allergic reactions and/or anaphylaxis, or serious adverse reactions to vaccines or allergy to kanamycin or any other component of the vaccine.
- Any contraindication to IM administration, as judged by the Investigator.
- Individuals with a history of any illness that, in the opinion of the Investigator, could potentially interfere with the results of the study or pose additional risk to the subjects by participating in the study.
- Sponsor employees or Investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted, including children of newly composed families.
Key Trial Info
Start Date :
October 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2025
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT06582277
Start Date
October 22 2024
End Date
June 2 2025
Last Update
June 6 2025
Active Locations (1)
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1
Centre for Vaccinology (CEVAC) Ghent University Hospital
Ghent, Belgium