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New England Journal of Medicine Publishes New Data on Gardasil,,Merck's Cervical Cancer Vaccine

ARDASIL was administered at 0.5 mL/rat/occasion (approximately 300-fold excess relative to the projected human dose on a mg/kg basis) by intramuscular injection. No adverse effects on mating, fertility, pregnancy, parturition, lactation, embryo-fetal or pre- and postweaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis noted in this study. In addition, there were no treatment-related effects on developmental signs, behavior, reproductive performance, or fertility of the offspring. The effect of GARDASIL on male fertility has not been studied. In clinical studies, women underwent urine pregnancy testing prior to administration of each dose of GARDASIL. Women who were found to be pregnant before completion of a 3-dose regimen of GARDASIL were instructed to defer completion of their vaccination regimen until resolution of the pregnancy. During clinical trials, 2266 women (vaccine = 1115 vs. placebo = 1151) reported at least 1 pregnancy each. Overall, the proportions of pregnancies with an adverse outcome were comparable in subjects who received GARDASIL and subjects who received placebo. Overall, 40 and 41 subjects in the group that received GARDASIL or placebo, respectively (3.6% and 3.6% of all subjects who reported a pregnancy in the respective vaccination groups), experienced a serious adverse experience during pregnancy. The most common events reported were conditions that can result in Caesarean section (e.g., failure of labor, malpresentation, cephalopelvic disproportion), premature onset of labor (e.g., threatened abortions, premature rupture of membranes), and pregnancy-related medical problems (e.g., pre-eclampsia, hyperemesis). The proportions of pregnant subjects who experienced such events were comparable between the vaccination groups. There were 15 cases of congenital anomaly in pregnancies that occurred in subjects who received GARDASIL and 16 cas
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