FDA licensure of bivalent human papillomavirus vaccine (HPV2, cervarix) for use in females and updated HPV vaccination recommendations from the advisory committee on immunization practices (ACIP)
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Author keywords
[No Author keywords available]
Indexed keywords
HUMAN PAPILLOMAVIRUS VACCINE L1, TYPE 6,11,16,18;
HUMAN PAPILLOMAVIRUS VACCINE, L1 TYPE 16, 18;
WART VIRUS VACCINE;
ADOLESCENT;
ADULT;
ANTIBODY PRODUCTION;
ARTICLE;
CHILD;
FEMALE;
FOOD AND DRUG ADMINISTRATION;
HUMAN;
HUMAN PAPILLOMAVIRUS TYPE 16;
HUMAN PAPILLOMAVIRUS TYPE 18;
IMMUNIZATION;
IMMUNOLOGY;
LICENSING;
PAPILLOMAVIRUS INFECTION;
RANDOMIZED CONTROLLED TRIAL;
UNITED STATES;
UTERINE CERVIX TUMOR;
ADOLESCENT;
ADULT;
ANTIBODY FORMATION;
CHILD;
FEMALE;
HUMAN PAPILLOMAVIRUS 16;
HUMAN PAPILLOMAVIRUS 18;
HUMANS;
IMMUNIZATION SCHEDULE;
LICENSURE;
PAPILLOMAVIRUS INFECTIONS;
PAPILLOMAVIRUS VACCINES;
RANDOMIZED CONTROLLED TRIALS AS TOPIC;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
UTERINE CERVICAL NEOPLASMS;
YOUNG ADULT;
A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (types 6/11/16/18) vaccine against high-grade cervical and external genital lesions
Kjaer SK, Sigurdsson K, Iversen OE, et al. A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (types 6/11/16/18) vaccine against high-grade cervical and external genital lesions. Cancer Prev Res 2009;2:868-78.
Food and Drug Administration, Product approval-prescribing information [package insert]. Gardasil [human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant], Merck & Co, Inc: Food and Drug Administration 2009. Available at, Accessed May 25, 2010
Food and Drug Administration. Product approval-prescribing information [package insert]. Gardasil [human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant], Merck & Co, Inc: Food and Drug Administration 2009. Available at http://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm094042.htm. Accessed May 25, 2010.
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Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): Final analysis of a double-blind, randomised study in young women
Paavonen J, Naud P, Salmeron J, et al. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet 2009;374:301-14.
Food and Drug Administration, Available at, Accessed May 25, 2010
Food and Drug Administration. Product approval-prescribing information [package insert]. Cervarix [human papillomavirus bivalent (types 16 and 18) vaccine, recombinant], GlaxoSmithKline Biologicals: Food and Drug Administration 2009. Available at http://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm186957.htm. Accessed May 25, 2010.
Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: A randomised controlled trial
Harper DM, Franco EL, Wheeler C, et al. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet 2004;364:1757-65.
Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: Analysis of a randomised placebo-controlled trial up to 6.4 years
Romanowski B, de Borba PC, Naud PS, et al. Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6.4 years. Lancet 2009;374:1975-85.
Human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine co-administered with other vaccines in female adolescents [Abstract]
Wheeler CM
Wheeler CM. Human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine co-administered with other vaccines in female adolescents [Abstract]. Presented at the 47th annual meeting of the Infectious Diseases Society of America, Philadelphia, PA, October 29-November 1, 2009.
Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials
Descamps D, Hardt K, Spiessens B, et al. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin 2009;5:332-40.
Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines
Verstraeten T, Descamps D, David MP, et al. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine 2008;26:6630-8.