Proper Name: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant Trade name: Gardasil Manufacturer: Merck & Co., Inc, License #0002 Product Information and Supporting Documents Approval History, Letters, Reviews, and Related Documents – Gardasil
Gardasil or Silgard Product Information Merck & Co.
Manufacturer, Merck & Co. To obtain product information on Gardasil or Silgard directly from the manufacturer, you can visit their website and search for product by name. Visit Merck’s database here.
Gardasil: Supplemental Biologics Licensing Application for Use in Anal Cancer Prevention
VRBPAC Briefing Document Presented by Merck on 17 November 2010 Human papillomaviruses (HPV) cause a significant burden of benign and malignant anogenital disease in men and women. The HPV-related anogenital cancers all develop through a common pathogenetic process of neoplastic change that begins with the necessary event of HPV infection. After cervical cancer, the anogenital […]
PRESCRIBING INFORMATION FOR GARDASIL
INDICATIONS AND USAGE GARDASIL is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine: Cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18 Genital warts (condyloma acuminata) caused by HPV types […]
Safety and Immunogenicity of the Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Men.
Pubmed
J Infect Dis. 2010 Sep 2
Wilkin T, Lee JY, Lensing SY, Stier EA, Goldstone SE, Berry JM, Jay N, Aboulafia D, Cohn DL, Einstein MH, Saah A, Mitsuyasu RT, Palefsky JM.
Abstract
Background. Human immunodeficiency virus type 1 (HIV-1)-infected men are at increased risk for anal cancer. Human papillomavirus (HPV) vaccination may prevent anal cancer caused by vaccine types. Methods. AIDS Malignancy Consortium Protocol 052 is a single-arm, open-label, multicenter clinical trial to assess the safety and immunogenicity of the quadrivalent HPV (types 6, 11, 16, and 18) vaccine in HIV-1-infected men. Men with high-grade anal intraepithelial neoplasia or anal cancer by history or by screening cytology or histology were excluded. Men received 0.5 mL intramuscularly at entry, week 8, and week 24. The primary end points were seroconversion to vaccine types at week 28, in men who were seronegative and without anal infection with the relevant HPV type at entry, and grade 3 or higher adverse events related to vaccination. Results. There were no grade 3 or greater adverse events attributable to vaccination among the 109 men who received at least 1 vaccine dose. Seroconversion was observed for all 4 types: type 6 (59 [98%] of 60), type 11 (67 [99%] of 68), type 16 (62 [100%] of 62), and type 18 (74 [95%] of 78). No adverse effects on CD4 counts and plasma HIV-1 RNA levels were observed. Conclusions. The quadrivalent HPV vaccine appears safe and highly immunogenic in HIV-1-infected men. Efficacy studies in HIV-1-infected men are warranted. Clinical trials registration. NCT 00513526 .
PMID: 20812850 [PubMed – as supplied by publisher]