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Background: The investigational 9-valent viruslike particle vaccine against human papillomavirus HPV includes the HPV types in the quadrivalent HPV qHPV vaccine 6, 11, 16, and 18 and five additional oncogenic types 31, 33, 45, 52, and Here we present the of a study of the efficacy and immunogenicity of the 9vHPV vaccine in women 16 to 26 years of age.

Methods: We performed a randomized, international, double-blind, phase 2b-3 study of the 9vHPV vaccine in 14, women. Participants received the 9vHPV vaccine or the qHPV vaccine in a series of three intramuscular injections on day 1 and at months 2 and 6. Serum was collected for analysis of antibody responses. Swabs of labial, vulvar, perineal, perianal, endocervical, and ectocervical tissue were obtained and used for HPV DNA testing, and liquid-based cytologic testing Papanicolaou testing was performed regularly.

Tissue obtained by means of biopsy or as part of definitive therapy including a loop electrosurgical excision procedure and conization was tested for HPV. : The rate of high-grade cervical, vulvar, or vaginal disease irrespective of HPV type i.

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The rate of high-grade cervical, vulvar, or vaginal disease related to HPV, 33, 45, 52, and 58 in a prespecified per-protocol efficacy population susceptible population was 0. Conclusions: The 9vHPV vaccine prevented infection and disease related to HPV, 33, 45, 52, and 58 in a susceptible population and generated an antibody response to HPV-6, 11, 16, and 18 that was noninferior to that generated by the qHPV vaccine.

The 9vHPV vaccine did not prevent infection and disease related to HPV types beyond the nine types covered by the vaccine. Funded by Merck; ClinicalTrials. Please enable it to take advantage of the complete set of features! Clipboard, Search History, and several other advanced features are temporarily unavailable. Search: Search. Advanced Clipboard. Display options Display options. Create file Cancel.

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N Engl J Med. No abstract available. Joura E, et al. PMID: No abstract available. Wieland U, et al. Tempfer C. Mihalyi A, et al. Similar articles Final efficacy, immunogenicity, and safety analyses of a nine-valent human papillomavirus vaccine in women aged years: a randomised, double-blind trial.

Huh WK, et al. Epub Sep 5. Vesikari T, et al. Pediatr Infect Dis J. Nine-valent HPV vaccine efficacy against related diseases and definitive therapy: comparison with historic placebo population. Giuliano AR, et al.

Gynecol Oncol. Epub Apr Spotlight on the 9-valent HPV vaccine. Lopalco PL. Drug Des Devel Ther. Expanded strain coverage for a highly successful public health tool: Prophylactic 9-valent human papillomavirus vaccine. Zhang Z, et al. Hum Vaccin Immunother. See all similar articles. Zhang S, et al. Cancers Basel. De Vincenzo R, et al. Vaccines Basel. Udomwan P, et al. Int J Mol Sci. Lee CY, et al. Front Immunol. Parents willingness to vaccinate their daughter against human papilloma virus and its associated factors in Bench-Sheko zone, southwest Ethiopia.

Destaw A, et al. See all "Cited by" articles. Multicenter Study Actions. Randomized Controlled Trial Actions. Research Support, Non-U. Gov't Actions. MeSH terms Adolescent Actions.

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Adult Actions. Double-Blind Method Actions. Female Actions. Humans Actions. Incidence Actions. Intention to Treat Analysis Actions.

Females women from Ponce sk can

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Disrespect and abuse of women during the process of childbirth in the Pelotas birth cohort