Pneumococcal antibody responses to some serotypes in PCV7 were decreased following co-administration of Menactra vaccine and PCV7 [see Concomitant Vaccine Administration (14.3)].

Do not mix Menactra vaccine with other vaccines in the same syringe. When Menactra vaccine is administered concomitantly with other injectable vaccines, the vaccines should be administered with different syringes and given at separate injection sites.

7.2. Immunosuppressive Therapies
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses) may reduce the immune response to vaccines.

8.USE IN SPECIFIC POPULATIONS
8.1. Pregnancy
Pregnancy Category C

Animal reproduction studies have not been conducted with Menactra vaccine. It is also not known whether Menactra vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. There are no adequate and well controlled studies in pregnant women. Menactra vaccine should only be given to a pregnant woman if clearly needed. Assessment of the effects on animal reproduction has not been fully conducted with Menactra vaccine as effects on male fertility in animals has not been eva luated. The effect of Menactra vaccine on embryo-fetal and pre-weaning development was eva luated in one developmental toxicity study in mice. Animals were administered Menactra vaccine on Day 14 prior to gestation and during the period of organogenesis (gestation Day 6). The total dose given per time point was 0.1 mL/mouse via intramuscular injection (900 times the human dose, adjusted by body weight). There were no adverse effects on pregnancy, parturition, lactation or pre-weaning development noted in this study. Skeletal examinations revealed one fetus (1 of 234 examined) in the vaccine group with a cleft palate. None were observed in the concurrent control group (0 of 174 examined). There are no data that suggest that this isolated finding is vaccine related, and there were no vaccine related fetal malformations or other evidence of teratogenesis observed in this study.

Healthcare providers are encouraged to register women who receive Menactra vaccine during pregnancy in Sanofi Pasteur Inc.'s vaccination pregnancy registry by calling 1-800-822-2463.

8.3.Nursing Mothers
It is not known whether Menactra vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Menactra vaccine is administered to a nursing woman.

8.4.Pediatric Use
Menactra vaccine is not approved for use in infants under 9 months of age. Available data show that infants administered three doses of Menactra vaccine (at 2, 4, and 6 months of age) had diminished responses to each meningococcal vaccine serogroup compared to older children given two doses at 9 and 12 months of age.

8.5.Geriatric Use
Safety and effectiveness of Menactra vaccine in adults older than 55 years of age have not been established.

11.DESCRIPTION
Menactra®, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, is a sterile, intramuscularly administered vaccine that contains Neisseria meningitidis serogroup A, C, Y and W-135 capsular polysaccharide antigens i