Safety and Immunogenicity of a 9-Valent Human Papillomavirus Vaccine Administered to 9- to 15-Year-Old Japanese Girls

Iwata, Satoshi; Murata, Shinichi; Han, Shi Rong; Wakana, Akira; Sawata, Miyuki; Tanaka, Yoshiyuki

doi:10.7883/yoken.jjid.2016.299

Cited by 12 publications

(14 citation statements)

References 18 publications

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“…This is similar to observations in the overall study population and may not be clinically meaningful, as robust HPV-11 antibody responses were observed with both vaccines and no cases of HPV-11–related persistent infection or disease were observed in per-protocol analyses [ 18 , 19 ]. GMTs to all 9 included HPV types were higher in girls and boys compared with young women from the same country, similar to previous reports in other regions (including Europe, Latin America, and North America [ 32 ], and Japan [ 25 ]). The 9vHPV vaccine was generally well tolerated in all subgroups.…”

Section: Discussionsupporting

confidence: 89%

“…Immunogenicity and safety data for Indian young women who participated in Study 002 are described, because Study 001 did not include this country. Study 002 did not include Japanese participants; a separate immunogenicity and safety study of the 9vHPV vaccine was conducted in a group of 100 Japanese girls (Study V503-008 [NCT01254643]), as reported separately [ 25 ].…”

Section: Methodsmentioning

confidence: 99%

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

Garland

Pitisuttithum

Ngan

et al. 2018

The Journal of Infectious Diseases

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Section: Discussionsupporting

confidence: 89%

Section: Methodsmentioning

confidence: 99%

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

Garland

Pitisuttithum

Ngan

et al. 2018

The Journal of Infectious Diseases

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“…Furthermore, no vaccine-related deaths were reported. Some observational studies also found similarly low levels of vaccine-related severe adverse events and no vaccine-related deaths [ 19 – 22 ].…”

Section: Discussionmentioning

confidence: 85%

Safety of Human Papillomavirus 9-Valent Vaccine: A Meta-Analysis of Randomized Trials

Costa

Cobucci

Silva

et al. 2017

Journal of Immunology Research

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Vaccination against human papillomavirus (HPV) has been progressively implemented in most developed countries for approximately 10 years. In order to increase the protection of the vaccines, a 9-valent vaccine (HPV9) was developed, which provides protection against nine types of the virus. Studies evaluating its safety are rare. Thus, we performed a meta-analysis of three clinical trials assessing adverse effects on women randomly vaccinated with HPV9 or tetravalent vaccine (HPV4), with the objective of analyzing whether the HPV9 is as safe as HPV4. An electronic data search was performed through the PubMed, Embase, Scopus, Web of Science, and SciELO databases. The studies selected 27,465 women who received one of the two vaccines. Pain (OR 1.72; 95% CI 1.62–1.82) and erythema (OR 1.29; 95% CI 1.21–1.36) occurred significantly more in the HPV9 group. However, there was no significant difference between the groups for the following adverse effects: headache (OR 1.07; 95% CI 0.99–1.15), dizziness (OR 1.09; 95% CI 0.93–1.27), and fatigue (OR 1.09; 95% CI 0.91–1.30), and the occurrence of serious events related to vaccination was similarly rare among those vaccinated. Therefore, our findings demonstrate that HPV9 in female patients is as safe as the tetravalent vaccine.

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“…The latest development is the approval of a nonavalent HPV vaccine by the FDA in 2014 which is able to provide protection against 9 types of HPV. There are currently three vaccines available: bivalent (HPV 16 and 18), quadrivalent (HPV 6,11,16 and 18) and nonavalent (HPV 6,11,16,18,31,33,45,52,58).…”

Section: Introductionmentioning

confidence: 99%

HPV vaccine development after more than ten years approval

Askandar

2020

MOG

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At present, ten years have passed since the human papillomavirus (HPV) vaccine was first approved for use in humans. Research related to HPV vaccine, both in terms of effectiveness and immugenicity in its development, has been widely carried out, such as in terms of the indications of the HPV vaccine use that is not only for preventing cervical cancer, the guidelines for administering 2-dose HPV vaccines for those under 15 years of age, and the discovery of the latest HPV vaccine types: nonavalent HPV vaccine. This review literature discusses all aspects of the development of HPV vaccine since it was first approved for use in humans in 2006.

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Safety and Immunogenicity of a 9-Valent Human Papillomavirus Vaccine Administered to 9- to 15-Year-Old Japanese Girls

Cited by 12 publications

References 18 publications

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

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

Safety of Human Papillomavirus 9-Valent Vaccine: A Meta-Analysis of Randomized Trials

HPV vaccine development after more than ten years approval

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