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New Vaccine Protects Infants as Young as Age 6 Weeks Against Meningococcal, Hib Disease
By News Staff
"It is the first meningococcal vaccine that can be given starting as young as 6 weeks of age," she said in a June 14 FDA news release.
The vaccine's package insert (14-page PDF; About PDFs) calls for MenHibrix to be given as a four-dose series at ages 2, 4, 6 and 12 through 15 months. The first dose may be given as early as age 6 weeks, and the fourth dose may be given as late as age 18 months.
In its approval letter, the FDA directs vaccine manufacturer GlaxoSmithKline to conduct a Phase III controlled, multicenter study to evaluate concomitant administration of MenHibrix with rotavirus, 13-valent pneumococcal conjugate and hepatitis A vaccines administered according to the CDC-recommended vaccine schedule. The study is to begin no later than Oct. 31, 2013, with a final study report to be submitted by Dec. 15, 2016.