Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Particip… (NCT06582277) | Clinical Trial Compass
CompletedPhase 2
Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836
Belgium117 participantsStarted 2024-10-22
Plain-language 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 five years ago in OVX836-002 or OVX836-003 studies. Participants who had received a placebo or Influvac Tetra® in previous studies would serve as controls and would receive the highest dose of OVX836 vaccine (480 µg) as a primary vaccination.
Who can participate
Age range20 Years – 64 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
✕
What they're measuring
1
Safety evaluation of OVX836 (180µg and 480µg)
Timeframe: From enrollment to the end of trial at 180 days.