ThRabis Pivotal Trial Information
I cannot provide specific information about a pivotal phase III trial for "ThRabis" as a rabies vaccine because the evidence provided does not contain any such trial data.
What the Evidence Actually Shows
The drug label evidence 1 refers to "Thyreoidea compositum® Injection Solution" - which is indicated for thyroid dysfunction and glandular dysfunction, not rabies prevention. This appears to be a mislabeling or database error, as this product has no relationship to rabies vaccination.
Available Rabies Vaccine Trial Data
The evidence does include several recent phase III rabies vaccine trials, but none are specifically labeled as "ThRabis":
Recent Phase III Rabies Vaccine Studies:
Recombinant nanoparticle vaccine (2021) 2:
- Design: Multi-center, open-label, assessor-blind, randomized 2:1 trial (n=800)
- Intervention: 3-dose recombinant rabies G protein vaccine (days 0,3,7) vs. 5-dose WHO vaccine
- Primary endpoint: Non-inferiority in seroprotection on day 14
- Results: 99.24% seroprotection in 3-dose arm vs. 97.72% in 5-dose arm (non-inferior); fewer adverse events (9.9% vs. 17.2%)
Sinovac serum-free vaccine (2026) 3:
- Design: Randomized, double-blind, active-controlled trial (n=2000, ages 10-60)
- Intervention: 5-dose Essen, 4-dose (D0,3,7,14), or 4-dose (D0,3,7,28) schedules
- Primary endpoint: Seroconversion rates on D14 and D42
- Results: 100% seroconversion by D14 in all groups; RVNA GMCs 33-37 IU/mL; maintained >97% seropositivity at 6 months
Critical Caveat
If you are seeking FDA approval information for a specific product called "ThRabis," you would need to access the actual FDA drug label or approval documents for that specific product, as this information is not present in the provided evidence.
The current ACIP guidelines [4-5] recommend a 4-dose rabies vaccine schedule (days 0,3,7,14) with rabies immunoglobulin for previously unvaccinated persons with WHO Category III exposure, which represents the standard of care regardless of specific vaccine brand.