Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NasoVAX · 1 trial · 1 indication
Adverse events (AEs): counts and percentages of subjects with AEs Day 1 to day 29 and Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181
Reactogenicity: counts and percentages of subjects with 'yes' to any reactogenicity event (nasal irritation, sneezing, nasal congestion, sore throat, change in smell, change in taste, change in vision, eye pain, headache, fatigue, muscle ache, nausea, vomiting, diarrhea, chills, fever)
| Arm | Type | Description |
|---|---|---|
| NasoVAX low dose | EXPERIMENTAL | NasoVAX administered by intranasal spray at a single dose of 1×10(9th) viral particles (vp) versus placebo |
| NasoVAX medium dose | EXPERIMENTAL | NasoVAX administered by intranasal spray at a single dose of 1×10(10th) viral particles (vp) versus placebo |
| NasoVAX high dose | EXPERIMENTAL | NasoVAX administered by intranasal spray at a single dose of 1×10(11th) viral particles (vp) versus placebo |
| Placebo | PLACEBO_COMPARATOR | Normal saline administered by intranasal spray at a single dose |
| Name | Type | Description |
|---|---|---|
| NasoVAX | BIOLOGICAL | Single ascending dose study |
Subjects who meet all of the following criteria may be included in the study: 1. Men and women 18 to 49 years of age, inclusive 2. Good general health status as determined by the Investigator 3. Adequate venous access for repeated phlebotomies 4. Screening laboratory results within institutional no...
NasoVAX is an investigational vaccine being developed for influenza. It is currently in Phase 2 clinical development and is being studied for its safety and immunogenicity in healthy adults. NasoVAX is not yet approved by the FDA and remains in clinical trials.
NasoVAX is being developed by Altimmune, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALT. The company is conducting clinical trials to evaluate the safety and immunogenicity of NasoVAX for influenza.
NasoVAX is currently in Phase 2 clinical development. It has completed one Phase 2 trial, which was a single-ascending-dose study evaluating the safety and immunogenicity of NasoVAX in healthy volunteers. NasoVAX is investigational and not yet approved.
NasoVAX has one completed clinical trial, identified as NCT03232567. This was a Phase 2, single-ascending-dose study of the safety and immunogenicity of NasoVAX, conducted in the United States with 60 participants. The trial was randomized, double-blind, and placebo-controlled.
No, NasoVAX is not FDA approved. It is an investigational vaccine currently in Phase 2 clinical development for influenza. The completed trial, NCT03232567, evaluated safety and immunogenicity, but NasoVAX has not yet received regulatory approval.