( 990.8) for anti-HPV 11 3056.9 (95%...)New England Journal of Medicine Publishes New Data on Gardasil,,Merck's Cervical Cancer Vaccine,Health

, 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 women who did not nurse during vaccine administration were 540.1 (95% CI: 523.5, 557.2) for anti-HPV 6, 746.3 (95% CI: 720.4, 773.3) for anti-HPV 11, 2290.8 (95% CI: 2180.7, 2406.3) for anti-HPV 16, and 456.0 (95% CI: 438.4, 474.3) for anti-HPV 18. Overall, 17 and 9 infants of subjects who received GARDASIL or placebo, respectively (representing 3.4% and 1.8% of the total number of subjects who were breast-feeding during the period in which they received GARDASIL or placebo, respectively), experienced a serious adverse experience. None was judged by the investigator to be vaccine related. In clinical studies, a higher number of breast-feeding infants (n = 6) whose mothers received GARDASIL had acute respiratory illnesses within 30 days post-vaccination of the mother as compared to infants (n = 2) whose mothers received placebo. In these studies, the rates of other adverse experiences in the mother and the nursing infant were comparable between vaccination groups. Pediatric Use The safety and efficacy of GARDASIL have not been evaluated in children younger than 9 years. Geriatric Use The safety and efficacy of GARDASIL have not been evaluated in adults above the age of 26 years. ADVERSE REACTIONS In 5 clinical trials (4 placebo-controlled), subjects were administered GARDASIL or placebo on the day of enrollment, and approximately 2 and 6 months thereafter. Few subjects (0.1%) discontinued due to adverse experiences. In all except 1 of the clinical trials, safety was evaluated using vaccination report card (VRC)-aided surveillance for 14 days after each injection of GARDASIL or placebo. The subjects who were monitored using VRC-aided surveillance included 5088 girls and women 9 through 26 years of age at enrollment who received GARDASIL and 3790 girls and women who receive
'"/>




Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32
Related medicine technology :

1. Research on New Treatment for Neglected Disease Published in The New England Journal of Medicine
2. Landmark Study Published in the New England Journal of Medicine Shows Important Benefits of Eprodisate (KIACTA) Treatment for Patients with Amyloid A (AA) Amyloidosis
3. Statement by Philip Home Chairman of the RECORD Study Steering Committee and Professor of Diabetes Medicine at Newcastle University in England
4. Large Geographic Differences in EpiPen Prescriptions in the U.S., From the Journal of Allergy and Clinical Immunology
5. Positive Aggrastat Results Featured in the Journal of the American College of Cardiology
6. Peer Reviewed Journal Article Indicates Repros Proellex Exhibits Potential for New Approach to the Treatment and Prevention of Breast Cancer
7. New Study in Journal of Pediatrics Suggests Synagis (Palivizumab) May Reduce Subsequent Recurrent Wheezing in Preterm Infants
8. Genetics Journal Thimerosal/Autism Study the Best Science Drug Company Money Can Buy
9. Interim Analysis of Crinone Pregnancy Study to Be Published in American Society for Reproductive Medicine Journal
10. Nuvelo Announces Publication of Phase 2 rNAPc2 Study Results in Journal of American College of Cardiology
11. Trophos Publishes ALS Article in Journal of Pharmacology and Experimental Therapeutics