The British and Canadian researchers recruited a total of 421 2-month-old infants for the phase II randomized, controlled trial. The 225 British infants received the new vaccine, called Menveo, at 2, 3 and 4 months or at 2 and 4 months of age, or they were given one of the current N. meningitides vaccines at 2 and 4 months, and then all received the new vaccine at 12 months. The 196 Canadian babies were given the new vaccine at 2, 4 and 6 months or at 2 and 4 months, and then at 12 months, they were either given another shot of the new vaccine, a shot of one of the current vaccines, or no vaccine at all, according to the study.
"The study showed that the [Menveo] vaccine was able to stimulate production of protective antibodies against all four meningococcal groups in most of the children receiving the vaccine," said Snape. "For example, for children receiving the vaccine at 2, 3, 4 and 12 months of age, protective antibody levels were seen in 94 percent or above for all the meningococcus types."
Additionally, Snape said the vaccine was well-tolerated, and there were no serious adverse events related to the vaccine. He also noted that the vaccine doesn't contain the controversial preservative, thimerosal.
"This is a potentially huge advance for the prevention of meningococcal disease," said the author of an accompanying editorial in the same issue of the journal, Dr. Lee Harrison, a professor of medicine and epidemiology at the University of Pittsburgh. "This vaccine is looking very promising."
Novartis is currently conducting phase III clinical trials on the vaccine and hopes to begin the licensing procedure in the United States sometime in 2008, though it would
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