New Vaccine Protects Infants as Young as Age 6 Weeks Against Meningococcal, Hib Disease

Family physicians now have a new weapon in their immunization armamentarium, thanks to the FDA's recent approval of GlaxoSmithKline Biologicals' application to market its meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine, MenHibrix, in the United States. The vaccine is indicated for the prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b (Hib) and is approved for use in children ages 6 weeks through 18 months.

According to Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research, approval of the new product "means there is now a combination vaccine that can be used to prevent potentially life-threatening Hib disease and two types of meningococcal disease in children."

"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.