Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine

SM Garland; TH Cheung; S McNeill; LK Petersen; J Romaguera; J Vazquez-Narvaez; O Bautista; C Shields; S Vuocolo; A Luxembourg

Journal article

Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine

SM Garland, TH Cheung, S McNeill, LK Petersen, J Romaguera, J Vazquez-Narvaez, O Bautista, C Shields, S Vuocolo, A Luxembourg

Vaccine | Published : 2015

DOI: 10.1016/j.vaccine.2015.08.059

Abstract

Objectives: To assess the safety and immunogenicity of the investigational 9-valent (6/11/16/18/31/33/45/52/58) HPV (9vHPV) vaccine in prior recipients of a 3-dose regimen of quadrivalent (6/11/16/18) HPV (qHPV) vaccine. Methods: V503-006 was a randomized, double-blinded, safety/tolerability and immunogenicity study of the 9vHPV vaccine in females 12-26 years of age who were previously vaccinated with qHPV vaccine. Subjects were randomized in a 2:1 ratio to receive 3 doses of 9vHPV vaccine (n= 618) or saline placebo (n= 306) at day 1, month 2, and month 6. Systemic, injection-site and serious adverse experiences (AEs) were monitored. Serum samples were collected at day 1, month 2, and month ..

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