title: Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil™ in adult women.
abstract: BACKGROUND
  Previous analyses from a randomized trial in women aged 24-45 have shown the quadrivalent HPV vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN) and external genital lesions (EGL) related to HPV 6/11/16/18 through 4 years. In this report we present long term follow-up data on the efficacy, safety and immunogenicity of the quadrivalent HPV vaccine in adult women.
  
  
  METHODS
  Follow-up data are from a study being conducted in 5 sites in Colombia designed to evaluate the long-term immunogenicity, effectiveness, and safety of the qHPV vaccine in women who were vaccinated at 24 to 45 years of age (in the original vaccine group during the base study [n = 684]) or 29 to 50 years of age (in the original placebo group during the base study [n = 651]). This analysis summarizes data collected as of the year 6 post-vaccination visit relative to day 1 of the base study (median follow-up of 6.26 years) from both the original base study and the Colombian follow-up.
  
  
  RESULTS
  There were no cases of HPV 6/11/16/18-related CIN or EGL during the extended follow-up phase in the per-protocol population. Immunogenicity persists against vaccine-related HPV types, and no evidence of HPV type replacement has been observed. No new serious adverse experiences have been reported.
  
  
  CONCLUSIONS
  Vaccination with qHPV vaccine provides generally safe and effective protection from HPV 6-, 11-, 16-, and 18-related genital warts and cervical dysplasia through 6 years following administration to 24-45 year-old women.
  
  
  BACKGROUND
  Clinicaltrials.govNCT00090220.
authors.affiliation: Instituto Nacional de Cancerologia, Bogotá, Colombia.
authors.forename: Joaquin
authors.initials: J
authors.lastname: Luna
authors.affiliation: Fundacion Cardioinfantil, Bogotá, Colombia.
authors.forename: Manuel
authors.initials: M
authors.lastname: Plata
authors.affiliation: Instituto Nacional de Cancerologia, Bogotá, Colombia.
authors.forename: Mauricio
authors.initials: M
authors.lastname: Gonzalez
authors.affiliation: Clinica del Country, Bogotá, Colombia.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Correa
authors.affiliation: Fundacion Santa Fe de Bogotá, Bogotá, Colombia.
authors.forename: Ivete
authors.initials: I
authors.lastname: Maldonado
authors.affiliation: Cafam, Bogotá, Colombia.
authors.forename: Claudia
authors.initials: C
authors.lastname: Nossa
authors.affiliation: Merck Sharp & Dohme Corp., Whitehouse Station, New Jersey, United States of America.
authors.forename: David
authors.initials: D
authors.lastname: Radley
authors.affiliation: Merck Sharp & Dohme Corp., Whitehouse Station, New Jersey, United States of America.
authors.forename: Scott
authors.initials: S
authors.lastname: Vuocolo
authors.affiliation: Merck Sharp & Dohme Corp., Whitehouse Station, New Jersey, United States of America.
authors.forename: Richard M
authors.initials: RM
authors.lastname: Haupt
authors.affiliation: Merck Sharp & Dohme Corp., Whitehouse Station, New Jersey, United States of America.
authors.forename: Alfred
authors.initials: A
authors.lastname: Saah
mesh_terms: D000328:Adult; D003105:Colombia; D003218:Condylomata Acuminata / Q000517:prevention & control; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D052140:Human papillomavirus 11 / Q000276:immunology; D052162:Human papillomavirus 16 / Q000276:immunology; D052161:Human papillomavirus 18 / Q000276:immunology; D052163:Human papillomavirus 6 / Q000276:immunology; D006801:Humans; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000517:prevention & control; D053918:Papillomavirus Vaccines / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D011247:Pregnancy; D012449:Safety; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000517:prevention & control
chemical_list: D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines