From Google Scholar & other sources: Selected Journal Articles, Newsletters, Dissertations, Theses, Commentary
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Pediatric Infectious Disease Journal
Published Ahead-of-Print
An Overview of Quadrivalent Human Papillomavirus Vaccine Safety – 2006 to 2015.
Vichnin, Michelle MD; Bonanni, Paolo MD; Klein, Nicola P. MD, PhD; Garland, Suzanne M. MD; Block, Stan L. MD; Kjaer, Susanne K. MD; Sings, Heather L. PhD; Perez, Gonzalo MD; Haupt, Richard M. MD MPH; Saah, Alfred J. MD; Lievano, Fabio MD; Velicer, Christine PhD; Drury, Rosybel PhD; Kuter, Barbara J. PhD, MPH
doi: 10.1097/INF.0000000000000793
Abstract
Background:
A quadrivalent human papillomavirus (HPV4) type 6/11/16/18 vaccine (GARDASIL/SILGARD(R)) has been licensed in many countries around the world for the prevention of cervical, vulvar, vaginal, and anal cancers and pre-cancers, 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, 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 8 years since licensure, including more than 15 studies in more than one million pre-adolescents, adolescents, and adults from various countries. Most have been performed in the general population though there have been some in special populations (pregnant women, human immunodeficiency virus infected individuals, and those with Systemic Lupus Erythematosus).
Results:
We present a summary of the published, post-licensure safety data from active and passive surveillance. Only syncope, and possibly skin infections were associated with vaccination in the post-licensure 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 pre-licensure 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.
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The Cochrane Library
Published Online: 3 JUL 2015
Qualitative Protocol
Parents’ and informal caregivers’ views and experiences of routine early childhood vaccination communication: qualitative evidence synthesis
Heather MR Ames1,*, Claire Glenton1, Simon Lewin1,2
Assessed as up-to-date: 1 JUL 2015
DOI: 10.1002/14651858.CD011787
Abstract
This is the protocol for a review and there is no abstract. The objectives are as follows:
The specific objectives of the review are to identify, appraise and synthesise qualitative studies exploring:
:: Parents’ and informal caregivers’ views and experiences regarding communication about childhood vaccinations and the manner in which it is communicated
:: The influence that vaccination communication has on parents’ and informal caregivers’ decisions regarding childhood vaccination
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Western Pacific Surveillance and Response Journal
2015, 6(3).
An assessment of measles vaccine effectiveness, Australia, 2006–2012
Alexis Pillsburyab and Helen Quinnac
a National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, The Children’s Hospital at Westmead and the University of Sydney, New South Wales, Australia.
b National Centre for Epidemiology and Population Health, Australian National University, Canberra, Australia.
c Discipline of Paediatrics and Child Health, University of Sydney, The Children’s Hospital at Westmead, Westmead, New South Wales, Australia.
doi:10.5365/wpsar.2015.6.2.
Abstract
Objective:
Vaccine effectiveness analysis serves as a critical evaluation for immunization programmes and vaccination coverage. It also contributes to maintaining public confidence with the vaccine providers. This study estimated measles vaccine effectiveness at the population level using Australian national notifications data between 2006 and 2012.
Methods:
Notification data were obtained from the National Notifiable Diseases Surveillance System. Vaccination status was classified according to whether a case had received zero, one or two doses of measles-containing vaccine. Cases aged less than 1 year and those with unknown vaccination status were excluded. All children with disease onset between 1 January 2006 and 31 December 2012 who were born after 1996 were included. Cases were matched to controls extracted from the Australian Childhood Immunisation Register according to date of birth and jurisdiction of residence. Vaccine effectiveness was estimated by conditional logistic regression. Sensitivity analyses were conducted to test data robustness.
Results:
Vaccine effectiveness was estimated at 96.7% (95% confidence interval [CI]: 94.5–98.0%) for one dose and 99.7% (95% CI: 99.2–99.9%) for two doses of measles vaccine. For at least one dose, effectiveness was estimated at 98.7% (95% CI: 97.9–99.2%). Sensitivity analyses did not significantly alter the base estimates.
Discussion:
Vaccine effectiveness estimates suggested that the measles vaccine was protective at the population level between 2006 and 2012. However, vaccination coverage gaps may have contributed to recent measles outbreaks and may represent a serious barrier for Australia to maintain measles elimination status.