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Data Published in The Lancet Show Gardasil was 100 Percent,Effective in Preventing High-Grade Vulvar and Vaginal Lesions,Caused by HPV Types 16 and 18

te pregnancies with estimated onset within 30 days or more than 30 days from administration of a dose of GARDASIL or placebo. For pregnancies with estimated onset within 30 days of vaccination, 5 cases of congenital anomaly were observed in the group that received GARDASIL compared to 0 cases of congenital anomaly in the group that received placebo. The congenital anomalies seen in pregnancies with estimated onset within 30 days of vaccination included pyloric stenosis, congenital megacolon, congenital hydronephrosis, hip dysplasia and club foot. Conversely, in pregnancies with onset more than 30 days following vaccination, 10 cases of congenital anomaly were observed in the group that received GARDASIL compared with 16 cases of congenital anomaly in the group that received placebo. The types of anomalies observed were consistent (regardless of when pregnancy occurred in relation to vaccination) with those generally observed in pregnancies in women aged 16 to 26 years. Pregnancy Registry for GARDASIL Merck & Co., Inc. maintains a Pregnancy Registry to monitor fetal outcomes of pregnant women exposed to GARDASIL. Patients and health care providers are encouraged to report any exposure to GARDASIL during pregnancy by calling (800) 986-8999. Lactation It is not known whether vaccine antigens or antibodies induced by the vaccine are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GARDASIL is administered to a nursing woman. A total of 995 nursing mothers (vaccine = 500, placebo = 495) were given GARDASIL or placebo during the vaccination period of the clinical trials. GMTs in nursing and non-nursing mothers were as follows: The GMTs in nursing mothers were 595.9 (95% CI: 522.5, 679.5) for anti-HPV 6, 864.3 (95% CI: 754.0, 990.8) for anti-HPV 11, 3056.9 (95% CI: 2594.4, 3601.8) for anti-HPV 16, and 527.2 (95% CI: 450.9, 616.5) for anti-HPV 18. The GMTs for
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