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Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries

by Pitisuttithum, P , Chu, T -Y , Moeller, E , Sawata, M , Shields, C , Ryu, H -S , Luxembourg, A , Takeuchi, Y , Yang, Y C , Kim, S C , Chen, C -A , Garland, S M , Cho, C -H , Ritter, M , Cheung, T H , Lee, C -Y , Kim, B -G , Bhatla, N , Kim, Y -T , Murata, S , Perez, G , Ngan, H Y S , Twu, N -F , Samakoses, R , Lalwani, S , Walia, A , Sakamoto, M , Song, Y -S , Huang, L -M , Kim, K -H , Yoshikawa, H , Kang, J -H , Ellison, M C , Han, S R

in Major and Brief Reports

2018

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Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries

in Major and Brief Reports

2018

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Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries

in Major and Brief Reports

2018

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Journal Article

Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries

Pitisuttithum, P,

Chu, T -Y,

Moeller, E,

Sawata, M,

Shields, C,

Ryu, H -S,

Luxembourg, A,

Takeuchi, Y,

Yang, Y C,

Kim, S C,

Chen, C -A,

Garland, S M,

Cho, C -H,

Ritter, M,

Cheung, T H,

Lee, C -Y,

Kim, B -G,

Bhatla, N,

Kim, Y -T,

Murata, S,

Perez, G,

Ngan, H Y S,

Twu, N -F,

Samakoses, R,

Lalwani, S,

Walia, A,

Sakamoto, M,

Song, Y -S,

Huang, L -M,

Kim, K -H,

Yoshikawa, H,

Kang, J -H,

Ellison, M C,

Han, S R

2018

Overview

A 9-valent human papillomavirus-6/11/16/18/31/33/45/52/58 (9vHPV) vaccine extends coverage to 5 next most common oncogenic types (31/33/45/52/58) in cervical cancer versus quadrivalent HPV (qHPV) vaccine. We describe efficacy, immunogenicity, and safety in Asian participants (India, Hong Kong, South Korea, Japan, Taiwan, and Thailand) from 2 international studies: a randomized, double-blinded, qHPV vaccine-controlled efficacy study (young women aged 16-26 years; NCT00543543; Study 001); and an immunogenicity study (girls and boys aged 9-15 years; NCT00943722; Study 002). Participants (N = 2519) were vaccinated at day 1 and months 2 and 6. Gynecological samples (Study 001 only) and serum were collected for HPV DNA and antibody assessments, respectively. Injection-site and systemic adverse events (AEs) were monitored. Data were analyzed by country and vaccination group. 9vHPV vaccine prevented HPV-31/33/45/52/58-related persistent infection with 90.4%-100% efficacy across included countries. At month 7, ≥97.9% of participants seroconverted for each HPV type. Injection-site AEs occurred in 77.7%-83.1% and 81.9%-87.5% of qHPV and 9vHPV vaccine recipients in Study 001, respectively, and 62.4%-85.7% of girls/boys in Study 002; most were mild to moderate. The 9vHPV vaccine is efficacious, immunogenic, and well tolerated in Asian participants. Data support 9vHPV vaccination programs in Asia. NCT00543543; NCT00943722.

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Publisher

Oxford University Press

Subject

Major and Brief Reports