An Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015

Background: A quadrivalent human papillomavirus (HPV4) type 6/11/16/18 vaccine (GARDASIL/SILGARD®) has been licensed in many countries around the world for the prevention of cervical, vulvar, vaginal, and anal cancers and precancers, as well as external genital warts causally related to HPV types 6/...

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Autores Principales: Vichnin, Michelle, Bonanni, Paolo, Klein, Nicola P., Garland, Suzanne M., Block, Stan L., Kjaer, Susanne K., Sings, Heather L., Perez, Gonzalo, Haupt, Richard M., Saah, Alfred J., Lievano, Fabio, Velicer, Christine, Drury, Rosybel, Kuter, Barbara J.
Formato: Artículo (Article)
Lenguaje:Inglés (English)
Publicado: Lippincott Williams and Wilkins 2015
Materias:
Acceso en línea:https://repository.urosario.edu.co/handle/10336/22776
https://doi.org/10.1097/INF.0000000000000793
id ir-10336-22776
recordtype dspace
spelling ir-10336-227762022-05-02T12:37:20Z An Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015 Vichnin, Michelle Bonanni, Paolo Klein, Nicola P. Garland, Suzanne M. Block, Stan L. Kjaer, Susanne K. Sings, Heather L. Perez, Gonzalo Haupt, Richard M. Saah, Alfred J. Lievano, Fabio Velicer, Christine Drury, Rosybel Kuter, Barbara J. Wart virus vaccine Wart virus vaccine Anaphylaxis Anus cancer Autoimmune disease Cerebrovascular accident Clinical protocol Clinical trial (topic) Drug safety Drug surveillance program Faintness Genital system Guillain Barre syndrome Human Human immunodeficiency virus infected patient Incidence Licensing Pharmacoepidemiology Precancer Pregnant woman Priority journal Public health Review Skin infection Systemic lupus erythematosus Uterine cervix cancer Vaccination Vagina cancer Venous thromboembolism Verruca vulgaris Vulva cancer Adolescent Adult Child Drug-Related Side Effects and Adverse Reactions Female Male Middle aged Papillomavirus Infections Pathology Postmarketing surveillance Pregnancy Young adult Adolescent Adult Child Drug-Related Side Effects and Adverse Reactions Female Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 Humans Male Middle Aged Papillomavirus Infections Pregnancy Young Adult Gardasil Human papillomavirus Safety Surveillance Vaccine Postmarketing Product Surveillance Background: A quadrivalent human papillomavirus (HPV4) type 6/11/16/18 vaccine (GARDASIL/SILGARD®) has been licensed in many countries around the world for the prevention of cervical, vulvar, vaginal, and anal cancers and precancers, as well as external genital warts causally related to HPV types 6/11/16/18. Across 7 phase 3 clinical trials involving more than 29,000 males and females ages 9-45 years, vaccination was generally well tolerated. Because of its expected public health benefit in reducing cervical cancer and other HPV-related diseases, the vaccine has been implemented in the national vaccination programs of several countries, with over 178 million doses distributed worldwide. Methods: Extensive efforts to assess the safety of the vaccine in routine practice have been conducted over the past 9 years since licensure, including more than 15 studies in more than 1 million preadolescents, adolescents and adults from various countries. Most have been performed in the general population although there have been some in special populations (pregnant women, HIV-infected individuals and those with systemic lupus erythematosus). Results: We present a summary of the published, postlicensure safety data from active and passive surveillance. Only syncope, and possibly skin infections were associated with vaccination in the postlicensure setting. Serious adverse events, such as adverse pregnancy outcomes, autoimmune diseases (including Guillain-Barre Syndrome and multiple sclerosis), anaphylaxis, venous thromboembolism and stroke, were extensively studied, and no increase in the incidence of these events was found compared with background rates. Conclusions: These results, along with the safety data from the prelicensure clinical trials, confirm that the HPV4 vaccine has a favorable safety profile. Key policy, medical and regulatory organizations around the world have independently reviewed these data and continue to recommend routine HPV vaccination. Copyright © 2015 Wolters Kluwer Health, Inc. 2015 2020-05-25T23:57:57Z info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion 8913668 https://repository.urosario.edu.co/handle/10336/22776 https://doi.org/10.1097/INF.0000000000000793 eng info:eu-repo/semantics/openAccess application/pdf Lippincott Williams and Wilkins instname:Universidad del Rosario
institution EdocUR - Universidad del Rosario
collection DSpace
language Inglés (English)
topic Wart virus vaccine
Wart virus vaccine
Anaphylaxis
Anus cancer
Autoimmune disease
Cerebrovascular accident
Clinical protocol
Clinical trial (topic)
Drug safety
Drug surveillance program
Faintness
Genital system
Guillain Barre syndrome
Human
Human immunodeficiency virus infected patient
Incidence
Licensing
Pharmacoepidemiology
Precancer
Pregnant woman
Priority journal
Public health
Review
Skin infection
Systemic lupus erythematosus
Uterine cervix cancer
Vaccination
Vagina cancer
Venous thromboembolism
Verruca vulgaris
Vulva cancer
Adolescent
Adult
Child
Drug-Related Side Effects and Adverse Reactions
Female
Male
Middle aged
Papillomavirus Infections
Pathology
Postmarketing surveillance
Pregnancy
Young adult
Adolescent
Adult
Child
Drug-Related Side Effects and Adverse Reactions
Female
Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
Humans
Male
Middle Aged
Papillomavirus Infections
Pregnancy
Young Adult
Gardasil
Human papillomavirus
Safety
Surveillance
Vaccine
Postmarketing
Product Surveillance
spellingShingle Wart virus vaccine
Wart virus vaccine
Anaphylaxis
Anus cancer
Autoimmune disease
Cerebrovascular accident
Clinical protocol
Clinical trial (topic)
Drug safety
Drug surveillance program
Faintness
Genital system
Guillain Barre syndrome
Human
Human immunodeficiency virus infected patient
Incidence
Licensing
Pharmacoepidemiology
Precancer
Pregnant woman
Priority journal
Public health
Review
Skin infection
Systemic lupus erythematosus
Uterine cervix cancer
Vaccination
Vagina cancer
Venous thromboembolism
Verruca vulgaris
Vulva cancer
Adolescent
Adult
Child
Drug-Related Side Effects and Adverse Reactions
Female
Male
Middle aged
Papillomavirus Infections
Pathology
Postmarketing surveillance
Pregnancy
Young adult
Adolescent
Adult
Child
Drug-Related Side Effects and Adverse Reactions
Female
Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
Humans
Male
Middle Aged
Papillomavirus Infections
Pregnancy
Young Adult
Gardasil
Human papillomavirus
Safety
Surveillance
Vaccine
Postmarketing
Product Surveillance
Vichnin, Michelle
Bonanni, Paolo
Klein, Nicola P.
Garland, Suzanne M.
Block, Stan L.
Kjaer, Susanne K.
Sings, Heather L.
Perez, Gonzalo
Haupt, Richard M.
Saah, Alfred J.
Lievano, Fabio
Velicer, Christine
Drury, Rosybel
Kuter, Barbara J.
An Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015
description Background: A quadrivalent human papillomavirus (HPV4) type 6/11/16/18 vaccine (GARDASIL/SILGARD®) has been licensed in many countries around the world for the prevention of cervical, vulvar, vaginal, and anal cancers and precancers, as well as external genital warts causally related to HPV types 6/11/16/18. Across 7 phase 3 clinical trials involving more than 29,000 males and females ages 9-45 years, vaccination was generally well tolerated. Because of its expected public health benefit in reducing cervical cancer and other HPV-related diseases, the vaccine has been implemented in the national vaccination programs of several countries, with over 178 million doses distributed worldwide. Methods: Extensive efforts to assess the safety of the vaccine in routine practice have been conducted over the past 9 years since licensure, including more than 15 studies in more than 1 million preadolescents, adolescents and adults from various countries. Most have been performed in the general population although there have been some in special populations (pregnant women, HIV-infected individuals and those with systemic lupus erythematosus). Results: We present a summary of the published, postlicensure safety data from active and passive surveillance. Only syncope, and possibly skin infections were associated with vaccination in the postlicensure setting. Serious adverse events, such as adverse pregnancy outcomes, autoimmune diseases (including Guillain-Barre Syndrome and multiple sclerosis), anaphylaxis, venous thromboembolism and stroke, were extensively studied, and no increase in the incidence of these events was found compared with background rates. Conclusions: These results, along with the safety data from the prelicensure clinical trials, confirm that the HPV4 vaccine has a favorable safety profile. Key policy, medical and regulatory organizations around the world have independently reviewed these data and continue to recommend routine HPV vaccination. Copyright © 2015 Wolters Kluwer Health, Inc.
format Artículo (Article)
author Vichnin, Michelle
Bonanni, Paolo
Klein, Nicola P.
Garland, Suzanne M.
Block, Stan L.
Kjaer, Susanne K.
Sings, Heather L.
Perez, Gonzalo
Haupt, Richard M.
Saah, Alfred J.
Lievano, Fabio
Velicer, Christine
Drury, Rosybel
Kuter, Barbara J.
author_facet Vichnin, Michelle
Bonanni, Paolo
Klein, Nicola P.
Garland, Suzanne M.
Block, Stan L.
Kjaer, Susanne K.
Sings, Heather L.
Perez, Gonzalo
Haupt, Richard M.
Saah, Alfred J.
Lievano, Fabio
Velicer, Christine
Drury, Rosybel
Kuter, Barbara J.
author_sort Vichnin, Michelle
title An Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015
title_short An Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015
title_full An Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015
title_fullStr An Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015
title_full_unstemmed An Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015
title_sort overview of quadrivalent human papillomavirus vaccine safety: 2006 to 2015
publisher Lippincott Williams and Wilkins
publishDate 2015
url https://repository.urosario.edu.co/handle/10336/22776
https://doi.org/10.1097/INF.0000000000000793
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score 12,131701