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Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial

Cervical intraepithelial neoplasia grade 2 or greater (CIN2+) is the surrogate endpoint used in licensure trials of human papillomavirus (HPV) vaccines. Vaccine efficacy against CIN3+, the immediate precursor to invasive cervical cancer, is more difficult to measure because of its lower incidence, b... Full description

Journal Title: Lancet Oncology 2012, Vol.13(1), pp.89-99
Main Author: Lehtinen, Matti
Other Authors: Paavonen, Jorma , Wheeler, Cosette M , Jaisamrarn, Unnop , Garland, Suzanne M , Castellsagué, Xavier , Skinner, S Rachel , Apter, Dan , Naud, Paulo , Salmerón, Jorge , Chow, Song-Nan , Kitchener, Henry , Teixeira, Júlio C , Hedrick, James , Limson, Genara , Szarewski, Anne , Romanowski, Barbara
Format: Electronic Article Electronic Article
Language: English
Subjects:
ID: ISSN: 1470-2045 ; E-ISSN: 1474-5488 ; DOI: 10.1016/S1470-2045(11)70286-8
Link: http://dx.doi.org/10.1016/S1470-2045(11)70286-8
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recordid: elsevier_sdoi_10_1016_S1470_2045_11_70286_8
title: Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial
format: Article
creator:
  • Lehtinen, Matti
  • Paavonen, Jorma
  • Wheeler, Cosette M
  • Jaisamrarn, Unnop
  • Garland, Suzanne M
  • Castellsagué, Xavier
  • Skinner, S Rachel
  • Apter, Dan
  • Naud, Paulo
  • Salmerón, Jorge
  • Chow, Song-Nan
  • Kitchener, Henry
  • Teixeira, Júlio C
  • Hedrick, James
  • Limson, Genara
  • Szarewski, Anne
  • Romanowski, Barbara
subjects:
  • Medicine
ispartof: Lancet Oncology, 2012, Vol.13(1), pp.89-99
description: Cervical intraepithelial neoplasia grade 2 or greater (CIN2+) is the surrogate endpoint used in licensure trials of human papillomavirus (HPV) vaccines. Vaccine efficacy against CIN3+, the immediate precursor to invasive cervical cancer, is more difficult to measure because of its lower incidence, but provides the most stringent evidence of potential cancer prevention. We report vaccine efficacy against CIN3+ and adenocarcinoma in situ (AIS) in the end-of-study analysis of PATRICIA (PApilloma TRIal against Cancer In young Adults). Healthy women aged 15–25 years with no more than six lifetime sexual partners were included in PATRICIA, irrespective of their baseline HPV DNA status, HPV-16 or HPV-18 serostatus, or cytology. Women were randomly assigned (1:1) to receive an HPV-16/18 AS04-adjuvanted vaccine or a control hepatitis A vaccine via an internet-based central randomisation system using a minimisation algorithm to account for age ranges and study sites....
language: eng
source:
identifier: ISSN: 1470-2045 ; E-ISSN: 1474-5488 ; DOI: 10.1016/S1470-2045(11)70286-8
fulltext: fulltext
issn:
  • 1470-2045
  • 14702045
  • 1474-5488
  • 14745488
url: Link


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titleOverall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial
creatorLehtinen, Matti ; Paavonen, Jorma ; Wheeler, Cosette M ; Jaisamrarn, Unnop ; Garland, Suzanne M ; Castellsagué, Xavier ; Skinner, S Rachel ; Apter, Dan ; Naud, Paulo ; Salmerón, Jorge ; Chow, Song-Nan ; Kitchener, Henry ; Teixeira, Júlio C ; Hedrick, James ; Limson, Genara ; Szarewski, Anne ; Romanowski, Barbara
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descriptionCervical intraepithelial neoplasia grade 2 or greater (CIN2+) is the surrogate endpoint used in licensure trials of human papillomavirus (HPV) vaccines. Vaccine efficacy against CIN3+, the immediate precursor to invasive cervical cancer, is more difficult to measure because of its lower incidence, but provides the most stringent evidence of potential cancer prevention. We report vaccine efficacy against CIN3+ and adenocarcinoma in situ (AIS) in the end-of-study analysis of PATRICIA (PApilloma TRIal against Cancer In young Adults). Healthy women aged 15–25 years with no more than six lifetime sexual partners were included in PATRICIA, irrespective of their baseline HPV DNA status, HPV-16 or HPV-18 serostatus, or cytology. Women were randomly assigned (1:1) to receive an HPV-16/18 AS04-adjuvanted vaccine or a control hepatitis A vaccine via an internet-based central randomisation system using a minimisation algorithm to account for age ranges and study sites....
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titleOverall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial
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Cervical intraepithelial neoplasia grade 2 or greater (CIN2+) is the surrogate endpoint used in licensure trials of human papillomavirus (HPV) vaccines. Vaccine efficacy against CIN3+, the immediate precursor to invasive cervical cancer, is more difficult to measure because of its lower incidence, but provides the most stringent evidence of potential cancer prevention. We report vaccine efficacy against CIN3+ and adenocarcinoma in situ (AIS) in the end-of-study analysis of PATRICIA (PApilloma TRIal against Cancer In young Adults).

Healthy women aged 15–25 years with no more than six lifetime sexual partners were included in PATRICIA, irrespective of their baseline HPV DNA status, HPV-16 or HPV-18 serostatus, or cytology. Women were randomly assigned (1:1) to receive an HPV-16/18 AS04-adjuvanted vaccine or a control hepatitis A vaccine via an internet-based central randomisation system using a minimisation algorithm to account for age ranges and study sites....

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abstract

Cervical intraepithelial neoplasia grade 2 or greater (CIN2+) is the surrogate endpoint used in licensure trials of human papillomavirus (HPV) vaccines. Vaccine efficacy against CIN3+, the immediate precursor to invasive cervical cancer, is more difficult to measure because of its lower incidence, but provides the most stringent evidence of potential cancer prevention. We report vaccine efficacy against CIN3+ and adenocarcinoma in situ (AIS) in the end-of-study analysis of PATRICIA (PApilloma TRIal against Cancer In young Adults).

Healthy women aged 15–25 years with no more than six lifetime sexual partners were included in PATRICIA, irrespective of their baseline HPV DNA status, HPV-16 or HPV-18 serostatus, or cytology. Women were randomly assigned (1:1) to receive an HPV-16/18 AS04-adjuvanted vaccine or a control hepatitis A vaccine via an internet-based central randomisation system using a minimisation algorithm to account for age ranges and study sites....

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