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.
Meningococcal and Hib diseases are caused by potentially deadly bacteria that can lead to meningitis and other very serious complications.
GSK is expected to work to respond to the questions posed by FDA. The company remains committed to making this vaccine available in the US.
The BLA submission included data from randomised, multicenter studies conducted in five countries with more than 9,000 infants. The vaccine demonstrated immunogenicity with a safety profile comparable to other US-licensed Hib vaccines in infants and toddlers when administered at two, four, six and 12-15 months of age.
GSK said that if approved, this combination vaccine would be administered in accordance with the existing CDC-recommended Hib vaccination schedule without increasing the number of shots given in the first two years of life.