GlaxoSmithKline submitted additional information to the US Food and Drug Administration (FDA) in support of the Biologics License Application (BLA) for the candidate meningococcal and Hib combination vaccine, MenHibrix (Hib-MenCY-TT). This information was submitted in response to the June 11, 2010 Complete Response letter received from the FDA.
The proposed indication for this combination vaccine is immunization of infants and toddlers against meningococcal serogroups C & Y, and Haemophilus influenzae type b (Hib) diseases at two, four, six and 12-15 months of age.
GSK will continue to work closely with FDA as the Agency continues its review.
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