✓ Translated by DotMD AI Clinical Council Source: Vaccine • Phase III Randomized Trial

Verify Primary Source: NIH PubMed PMID #41401704 ↗

Phase III Randomized Trial: Immunogenicity, safety, and lot consistency of the anthrax vaccine adsorbed, adjuvanted for post-exposure prophylaxis of anthrax in healthy adults (N = 3,689)

Original Paper Title: “Immunogenicity, safety, and lot consistency of the anthrax vaccine adsorbed, adjuvanted for post-exposure prophylaxis of anthrax in healthy adults: A phase 3, randomized, double-blind trial”

Elena Rostova (AI Quant) Rigor Score

96 / 100

Sample Size (Participants)

N = 3,689

Evidence Classification

Phase III Randomized Trial

Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways

The study met the pre-defined endpoint criteria, demonstrating protective level of immune response and non-inferiority of CYFENDUS to BioThrax vaccination. The CYFENDUS vaccine was well-tolerated in healthy adults.
Study Design & Sample: Phase III Randomized Trial published in Vaccine (N = 3689 human participants).
Biostatistical Rigor Score: 96/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Vaccine (2026), this phase iii randomized trial evaluating 3,689 human participants investigated: This double-blinded randomized Phase 3 study evaluated the immunogenicity and safety of CYFENDUS® vaccine (AV7909; Anthrax Vaccine Adsorbed, Adjuvanted) to support licensure for post-exposure prophylaxis following suspected or confirmed Bacillus anthracis exposure when administered with the recommended antibacterial drugs. Key clinical takeaway: The study met the pre-defined endpoint criteria, demonstrating protective level of immune response and non-inferiority of CYFENDUS to BioThrax vaccination. The CYFENDUS vaccine was well-tolerated in healthy adults.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Vaccine, 2026-02-06; N = 3689; Rigor 96/100): The study met the pre-defined endpoint criteria, demonstrating protective level of immune response and non-inferiority of CYFENDUS to BioThrax vaccination. The CYFENDUS vaccine was well-tolerated in healthy adults.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: healthy-back-institute-rub-on-relief-analgesic → Rx: tice-bcg-bacillus-calmette-guerin → Condition: anthrax → Condition: vaccines →

Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about PMID 41401704: Phase III Randomized Trial: Immunogenicity, safety, and lot consistency of the anthrax vaccine adsorbed, adjuvanted for post-exposure prophylaxis of anthrax in healthy adults (N = 3,689)

3 of 3 Free Questions Remaining