Title |
Safety and Immunogenicity Study of a 9-Valent Human Papillomavirus Vaccine Administered to 9-To-15 Year-Old Japanese Girls
|
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Published in |
Japanese Journal of Infectious Diseases, December 2016
|
DOI | 10.7883/yoken.jjid.2016.299 |
Pubmed ID | |
Authors |
Satoshi Iwata, Shinya Murata, Shi Rong Han, Akira Wakana, Miyuki Sawata, Yoshiyuki Tanaka |
Abstract |
A 9-valent human papillomavirus (HPV 6/11/16/18/31/33/45/52/58) virus-like particle (VLP) vaccine (9vHPV) has been proven highly efficacious in preventing anogenital disease related with vaccine HPV types in a pivotal Phase III study in women aged 16 to 26 years. We report here the results of an open-label phase III study conducted to bridge the findings in women age 16 to 26 years to Japanese girls aged 9 to 15 years. All subjects (n = 100) received a 3-dose regimen of 9vHPV vaccine at day 1, month 2 and month 6. Anti-HPV serologic assays were performed at day 1, month 7, month 12, month 24 and month 30. At month 7 (4 weeks after dose 3), 100% of subjects seroconverted for each vaccine HPV type. Increases in geometric mean titers of anti-HPV 6/11/16/18/31/33/45/52/58 in girls were similar to those in Japanese women aged 16 to 26 years in the pivotal phase III study. Persistence of anti-HPV responses was observed through 2 years after dose 3. In addition, administration of 9vHPV vaccine was generally well tolerated in Japanese girls. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
Japan | 27 | 31% |
United States | 2 | 2% |
Unknown | 58 | 67% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 85 | 98% |
Scientists | 2 | 2% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 44 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 10 | 23% |
Researcher | 5 | 11% |
Other | 4 | 9% |
Student > Bachelor | 3 | 7% |
Student > Doctoral Student | 2 | 5% |
Other | 5 | 11% |
Unknown | 15 | 34% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 10 | 23% |
Nursing and Health Professions | 4 | 9% |
Immunology and Microbiology | 3 | 7% |
Agricultural and Biological Sciences | 2 | 5% |
Biochemistry, Genetics and Molecular Biology | 2 | 5% |
Other | 6 | 14% |
Unknown | 17 | 39% |