Food And Drug Administration
Center For Biologics Evaluation And Research
Vaccines And Related Biological Products Advisory Committee Meeting
1. Are the available data adequate to support
the efficacy of Menactra, i.e., non-inferiority of the antibody response to
Menactra compared to the licensed polysaccharide, Menomune, when administered
to individuals 11-55 years of age? If
not, what additional data are necessary?
2. Are the available data adequate to support
the safety of Menactra when administered to individuals 11-55 years of
age? If not, what additional data are
necessary?
3.
Please discuss the adequacy of the data regarding of the use of Menactra with
other vaccines likely to be concurrently administered, e.g. Td.
4. Please identify any issues that should be
addressed in post-licensure studies.