Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OVX836 shot · 1 trial · 2 indications
Description: Proportion of subjects reporting: - solicited local and systemic symptoms within 7 days after vaccine administration - unsolicited AEs within 29 days after vaccine administration - SAEs during the entire study duration - ILIs and RT-PCR confirmed influenza A or B (overall and occurring more than 14 days post-vaccination, i.e., vaccine failure), RSV and/or SARS-CoV-2.
| Arm | Type | Description |
|---|---|---|
| OVX836 - 180μg dose level | EXPERIMENTAL | 180 µg dose of an adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus. |
| OVX836 - 480μg dose level | EXPERIMENTAL | 480 µg dose of an adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus. |
| Name | Type | Description |
|---|---|---|
| OVX836 shot | BIOLOGICAL | One single administration intramuscularly at Day 1. |
Inclusion Criteria: 1. Subject who voluntarily provides written informed consent to participate in the study. 2. Healthy male or female subjects, as determined by medical history and medical examination 3. Subject compliant with the reproductive criteria for female participants 4. Subjects who part...
OVX836 shot is an investigational vaccine being studied for vaccine-preventable diseases, specifically influenza. It is designed to boost immune responses in participants who have previously received the vaccine. The drug is currently in Phase 2 clinical development and is not yet approved for public use.
OVX836 shot is being developed by Harmony Biosciences Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol HRMY. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational influenza vaccine.
OVX836 shot is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness. The most recent trial, NCT06582277, has been completed.
OVX836 shot has been studied in one completed Phase 2 clinical trial, NCT06582277. This trial evaluated the safety and immunogenicity of two dose levels of the vaccine as a booster in 117 participants who had previously received OVX836. The study was conducted in Belgium and included healthy volunteers aged 20 years and older.
Yes, OVX836 shot is the same drug as OVX836. The clinical trial NCT06582277 refers to the vaccine as OVX836, and the shot is the administration form. The drug is an investigational influenza vaccine being developed by Harmony Biosciences Holdings, Inc.