Merck’s Investigational 9- valent HPV Vaccine, V5. Prevented 9. 7 Percent of Cervical, Vaginal and Vulvar Pre- cancers Caused by Five Additional HPV Types, in Phase III Study. WHITEHOUSE STATION, N. J.- -(BUSINESS WIRE)- -Merck (NYSE: MRK), known as MSD outside the United States and Canada. Phase III efficacy study, its. HPV vaccine (V5. 03) prevented approximately 9. HPV types. 3. 1, 3. V5. 03 also generated immune responses to HPV. GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 1. 3/19/2015 MERCK VACCINE PATIENT ASSISTANCE PROGRAM INFORMATION FOR AITC CLIENTS Cost: $39 per shot (vaccine administration fee) Vaccines: Zostavax® (Shingles. Merck Vaccine Patient Assistance Program. This private and confidential program provides vaccines free of charge to. The Merck Patient Assistance Program, Inc.. UNIVERSITY HEALTH CENTER GARDASIL (HPV) Merck Vaccine Patient Assistance Program If you think you might qualify for this program: 1. Complete and print the. Gardasil, the vaccine that 'protects' women against the HPV virus and cervical cancer, may have potentially dangerous side effects. Merck’s Investigational 9-valent HPV Vaccine, V503, Prevented 97 Percent of Cervical, Vaginal and Vulvar Pre-cancers Caused by Five Additional HPV Types, in Phase. *Please note this program is not determined or provided by Women’s Health Specialists, it is a separate service offered by an outside source not affiliated with our. SECTION 1: Applicant Information (Patient should complete all information in Section 1.) Patient’s First Name US Resident* Yes No. Vaccine, Recombinant]. V5. 03 includes five more HPV types. HPV types (6, 1. 1. GARDASIL. These data, along with results of two other Phase. III studies, will be presented for the first time at the European. Research Organisation on Genital Infection and Neoplasia (EUROGIN). Congress during a late- breaker oral session on Tuesday, November 5. Results from the pivotal Phase III efficacy study (abstract #SS 8- 4). The pivotal Phase III study (Protocol 0. V5. 03 (n=7,0. 99) compared to GARDASIL. The primary efficacy analysis was. HPV types at enrollment. HPV types through. Month 7 (per- protocol population). The results were as follows. CI; 8. 0. 9, 9. 9. CIN (cervical. intraepithelial neoplasia) 2/3+, VIN (vulvar intraepithelial. Va. IN (vaginal intraepithelial neoplasia) 2/3+]. HPV types 3. 1, 3. V5. 03 vs. 3. 0 cases in the group that received GARDASIL [Human. Papillomavirus Quadrivalent (Types 6, 1. Vaccine. Recombinant]). CI; 9. 1. 8, 9. 9. CIN, VIN, Va. IN). HPV types 3. 1, 3. V5. 03 vs. 1. 03 cases in the group that received GARDASIL). CI; 9. 4. 4, 9. 7. HPV infection with HPV types 3. V5. 03 vs. 8. 10 cases in the group that. GARDASIL). Because GARDASIL does not contain the five additional HPV types in V5. GARDASIL were expected. In the Phase III studies being presented for the first time, V5. HPV types,” said Elmar Joura. M. D., Associate Professor of Gynecology and Obstetrics, Medical. University of Vienna and Comprehensive Cancer Center, Vienna, Austria. EUROGIN. Non- inferior immunogenicity for the four HPV types (6, 1. GARDASIL was a second primary endpoint in this study. Because. GARDASIL has been shown in clinical studies to be highly effective. HPV types 6, 1. 1, 1. HPV types were expected, making it. V5. 03 for these four types. Therefore, antibody levels were evaluated for these four HPV types. V5. 03 generated immune responses for HPV 6, 1. GMTs) and seroconversion. Month 7) that were non- inferior to those generated by GARDASIL. In the study, the seroconversion rates were 9. HPV types 6. and 1. HPV types 1. 1 and 1. V5. 03 group. The. GARDASIL were 9. 9. HPV types 6, 1. 1, 1. These results are to support the bridging of the efficacy. GARDASIL for HPV types 6, 1. V5. 03. Safety of V5. SS 8- 7). In this study, the frequencies of adverse event (AE) reports were. V5. 03 and GARDASIL [Human Papillomavirus. Quadrivalent (Types 6, 1. Vaccine, Recombinant]; however. AEs (9. 0. 8 percent vs. V5. 03 group. Injection- site pain was mostly reported as mild or moderate in intensity. The majority of injection- site swelling and erythema. The most. frequently reported vaccine- related systemic AEs (frequency greater than. V5. 03 compared to GARDASIL, respectively. Our investigational vaccine V5. HPV- associated precancerous. Roger M. Perlmutter, M. D., Ph. D.. president of Merck Research Laboratories. With our ongoing commitment. GARDASIL. and we expect to submit a Biologics License Application for V5. U. S. Food and Drug Administration before the end of 2. Results of adolescent immunobridging studies for V5. SS 8- 5 and #SS 8- 6). Also presented at EUROGIN were results from two open- label. V5. 03 in adolescents. Immunobridging studies. HPV, and therefore, efficacy against. Immunogenicity ‘bridging. In Protocol 0. 02, which is aimed at extending the pivotal efficacy study. Immune responses to V5. All study participants in the per- protocol population received. V5. 03 over a six- month period and were evaluated at month. GMTs and seroconversion rates. Results from this study showed. V5. 03 in adolescent males and females. HPV types. 9. 9. 8- 1. HPV types at month 7 compared to 9. The safety profile of V5. GARDASIL [Human. Papillomavirus Quadrivalent (Types 6, 1. Vaccine. Recombinant]. In Protocol 0. 09, 6. HPV vaccine were randomized into two groups – 3. V5. 03 and 3. 00 who received GARDASIL – to compare the immune. HPV types 6, 1. 1, 1. All study. participants in the per- protocol population received three doses of. GARDASIL or V5. 03 over a six- month period and were evaluated at month 7. GMTs and seroconversion rates. In this study, immunogenicity of V5. GARDASIL in adolescent females for HPV. HPV types 6, 1. 1, 1. The. overall safety profile of V5. GARDASIL, with. higher frequency of injection- site swelling with V5. About GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 1. Vaccine, Recombinant]. GARDASIL is indicated in the United States for use in girls and young. HPV types 1. 6 and 1. HPV types 6 and 1. HPV types 6, 1. 1, 1. GARDASIL is also approved for use. HPV types 1. 6 and 1. HPV types. 6 and 1. HPV types 6. 1. 1, 1. Important information about GARDASIL. GARDASIL does not eliminate the necessity for women to continue to. Recipients of GARDASIL. GARDASIL has not been demonstrated to provide protection against. HPV types to which a person has. GARDASIL is not intended to be used for treatment of active external. GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 1. Vaccine, Recombinant] has not been demonstrated to protect against. HPV types not contained in the vaccine. Not all vulvar, vaginal and anal cancers are caused by HPV, and GARDASIL. HPV Types 1. 6 and 1. Select safety information for GARDASIL. GARDASIL is contraindicated in individuals with hypersensitivity. GARDASIL. Because vaccinees may develop syncope, sometimes resulting in falling. Syncope, sometimes associated with tonic- clonic movements. GARDASIL. When syncope is associated with tonic- clonic movements. GARDASIL is not recommended for use in pregnant women. The most common adverse reaction was headache. Common adverse reactions. GARDASIL at a frequency of at. Dosage and administration for GARDASIL. GARDASIL is a ready- to- use, three- dose, intramuscular vaccine. GARDASIL. should be administered in three separate intramuscular injections in the. The following dosage schedule is recommended: first dose at. About HPV and cancer. Human papillomavirus (HPV) causes virtually all cervical cancer cases. Cervical. cancer is the third most common type of cancer among women worldwide. It. is estimated that approximately 5. The seven cancer- causing HPV types in V5. These seven HPV types also can cause. After HPV types 1. HPV types in V5. 03 are the most common cervical. HPV types 6 and 1. About Merck. Today's Merck is a global healthcare leader working to help the world be. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and. We also demonstrate our commitment to increasing access to. For. more information, visit www. Twitter. Facebook. You. Tube. Merck Forward- Looking Statement. This news release includes “forward- looking statements” within the. United States Private. Securities Litigation Reform Act of 1. These statements are based. Merck’s management and are. There can be no. guarantees with respect to pipeline products that the products will. If underlying assumptions prove inaccurate or. Risks and uncertainties include but are not limited to, general industry. United States and internationally; global trends toward health care cost. Merck’s ability to accurately. Merck’s patents and other protections. Merck undertakes no obligation to publicly update any forward- looking. Additional factors that could cause results to differ. Merck’s 2. 01. 2 Annual Report on Form 1. K and the company’s other. Securities and Exchange Commission (SEC) available at. SEC’s Internet site (www. Please see Prescribing Information for GARDASIL®. Patient Information for GARDASIL at http: //www.
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