The study of the M-001 vaccine candidate had two primary targets, BiondVax said: to check its safety and the cellular immune responses specific to influenza. BiondVax said it is now considering proceeding directly to testing the clinical efficacy of a vaccination with M-001 alone in a pivotal Phase 3 clinical trial, in light of "these encouraging clinical trial results" that confirmed previous study results, the company said. In the trial, clinical efficacy is to be assessed by measuring a reduction of flu illness rate and severity. These same findings were reported by the company in November, as preliminary results of the study. The primary safety results showed that M-001 has a good safety profile and is well tolerated, the company said in a statement.
High-dose flu vaccine reduces hospital visits for nursing home residents
So we asked if the high-dose vaccine also would work better than regular-dose vaccine in the population we consider least able to respond. For every 69 people given the high-dose vaccine vs. the standard-dose vaccine, one more person stayed out of the hospital during the flu season. Just under half the homes, 409 to be exact, administered the high-dose vaccine while the other 414 provided a standard dose. But a significant reduction in hospitalizations can still be a benefit, Gravenstein said, even though the high-dose vaccine is more expensive than the standard-dose vaccine. A large, randomized clinical trial tested whether a flu vaccine with four times the antigen of a standard vaccine could reduce the risk of hospitalization among those especially vulnerable seniors.collected by :Lucy William
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