H5N1 IIV - IM for Flu (IN-NE-rH5 Trial)

"This clinical trial requires 40 participants aged 18-45 who have influenza pandemic. Furthermore, female applicants must not be pregnant or nursing and will need to use an acceptable birth control method for 3 months prior and following the final vaccination if they are premenopausal. Men and women deemed as being in good health after physical examination can apply, but must also pass a comprehension assessment with a score of 70% or higher (with two attempts permitted). Additionally, those involved should expect their leftover specimens to potentially be used for future research purposes and anticipate receiving the number of doses recommended by the CDC from either EUA authorized or licensed COVID-19 vaccine"

"The safety of H5N1 IIV-IM was cautiously rated as a 1 due to the preliminary nature of this Phase 1 clinical trial, meaning there is scarce evidence regarding its efficacy and safety."

"The information on clinicaltrials.gov states that, as of 9/21/2022, this medical trial is no longer seeking to recruit patients. However, there are 112 other investigations actively recruiting individuals at the present moment; this study was originally posted on July 7th 2022."

"This study's admission criteria requires that participants must lie between the age of 18 and 45. Moreover, there are 40 separate clinical trials dedicated to individuals below 18 while 70 cater towards patients who surpass 65 years old."

"As outlined by the trial sponsor, BlueWillow Biologics, the primary outcome over a 36-day period is Mucosal Vaccine Specific IgA Geometric Mean Titer (GMT). Additionally, this investigation will be assessing secondary objectives such as evaluating Hematological and biochemical laboratory abnormality (Class 1 of higher) within 7 days post vaccination with intramuscular H5N1 IIV vaccine; counting Solicited reactions and general AEs within seven days after injection; and monitoring Medical Attended Adverse Events (MAAEs) for up to 28 days following administration."