Reported adverse events in girls aged 13–16 years after vaccination with the human papillomavirus (HPV)-16/18 vaccine in the Netherlands

Klooster, Tessa M. van’t; Kemmeren, Jeanet M.; Maas, Nicoline A.T. van der; Melker, Hester E. de

doi:10.1016/j.vaccine.2011.04.050

Cited by 23 publications

(11 citation statements)

References 15 publications

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“…In other clinical trials and surveillance studies conducted in different countries such as Japan, the Netherlands and United Kingdom7, 8, 9, 10, 11, 12, 13, 14, 15, 24, 25, 26, 27, 28, 29, transient injection‐site pain lasting for less than 5 days 30 was consistently the most commonly occurring AE. The results of the present study now provide further evidence that the safety profile of the HPV‐16/18 AS04‐adjuvanted vaccine is similar when administered to women in Korea.…”

Section: Discussionmentioning

confidence: 84%

Six‐year multi‐centre, observational, post‐marketing surveillance of the safety of the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 10–25 years in Korea

Kim

Song²,

Chen

et al. 2017

Pharmacoepidemiology and Drug

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PurposeTo evaluate the safety of HPV‐16/18 AS04‐adjuvanted vaccine when administered as per the PI in Korea.MethodsA total of 3084 women aged 10–25 years were enrolled in this post‐marketing surveillance from 2008 to 2014. Subjects were invited to receive three doses of the vaccine (0, 1 and 6 months), and participants who received at least one dose were included in the analysis. Adverse events (AEs), adverse drug reactions (ADRs) and serious AEs (SAEs) were recorded after each dose. All AEs, ADRs and SAEs were presented with exact 95% confidence intervals (CI) (NCT01101542).ResultsInjection‐site pain was the most frequent AE and ADR reported by 322 subjects (10.4% [95%CI: 9.4–11.6]); the local pain was transient and lasted 4–7 days in most cases. Dysmenorrhoea and vaginitis were the most common unexpected AEs reported by 30 (1.0% [95%CI: 0.7–1.4]) and 16 subjects (0.7% [95%CI: 0.3–0.8]), respectively. Pain (toe pain, leg pain and body pain [one case each]; foot pain [two cases]) was the most common unexpected ADR reported by five subjects (0.2% [95%CI: 0.1–0.4]). Four subjects reported a single SAE (one case each of exostosis, gastroenteritis, abortion and tonsillitis); none were fatal. All SAEs were assessed as unlikely to be related to vaccination; gastroenteritis, exostosis and tonsillitis resolved during the study period.ConclusionsThis is the first post‐marketing surveillance study in Korea that provides 6‐year safety data for HPV‐16/18 AS04‐adjuvanted vaccine. The vaccine showed an acceptable safety profile and favourable benefit/risk ratio when given to women aged 10–25 years in Korea. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.

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Section: Discussionmentioning

confidence: 84%

Six‐year multi‐centre, observational, post‐marketing surveillance of the safety of the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 10–25 years in Korea

Kim

Song²,

Chen

et al. 2017

Pharmacoepidemiology and Drug

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“…Van Klooster et al . [59] found, in a post-marketing study conducted on over 1000 girls vaccinated with bHPVv, that myalgia was the systemic event most often reported, followed by fatigue and headache; the study also observed that older girls reported having myalgia, fatigue, listlessness, dizziness, nausea, sleeping problems, cough, shortness of breath and diarrhea after the first dose significantly more often than younger girls. Levi et al .…”

Section: Safety Evaluationmentioning

confidence: 91%

Safety of human papillomavirus vaccines: a review

Stillo

Santisteve²,

Lopalco³

2015

Expert Opinion on Drug Safety

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Introduction: Between 2006 and 2009, two different human papillomavirus virus (HPV) vaccines were licensed for use: a quadrivalent (qHPVv) and a bivalent (bHPVv) vaccine. Since 2008, HPV vaccination programmes have been implemented in the majority of the industrialized countries. Since 2013, HPV vaccination has been part of the national programs of 66 countries including almost all countries in North America and Western Europe. Despite all the efforts made by individual countries, coverage rates are lower than expected. Vaccine safety represents one of the main concerns associated with the lack of acceptance of HPV vaccination both in the European Union/European Economic Area and elsewhere. Areas covered: Safety data published on bivalent and quadrivalent HPV vaccines, both in pre-licensure and post-licensure phase, are reviewed. Expert opinion: Based on the latest scientific evidence, both HPV vaccines seem to be safe. Nevertheless, public concern and rumors about adverse events (AE) represent an important barrier to overcome in order to increase vaccine coverage. Passive surveillance of AEs is an important tool for detecting safety signals, but it should be complemented by activities aimed at assessing the real cause of all suspect AEs. Improved vaccine safety surveillance is the first step for effective communication based on scientific evidence.

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“…Safety of HPV vaccines was studied in both clinical trials before they were licensed and through post-licensure surveillance programmes ( 224 – 233 ). Like any other vaccines administered by intramuscular route, the HPV vaccinees may get inflammation (pain, erythema, swelling and pruritus) at the injection site.…”

Section: Hpv Diseasementioning

confidence: 99%

Advances in Designing and Developing Vaccines, Drugs and Therapeutic Approaches to Counter Human Papilloma Virus

Dadar

Chakraborty²,

Dhama

et al. 2018

Front. Immunol.

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Human papillomavirus (HPV) is a viral infection with skin-to-skin based transmission mode. HPV annually caused over 500,000 cancer cases including cervical, anogenital and oropharyngeal cancer among others. HPV vaccination has become a public-health concern, worldwide, to prevent the cases of HPV infections including precancerous lesions, cervical cancers, and genital warts especially in adolescent female and male population by launching national programs with international alliances. Currently, available prophylactic and therapeutic vaccines are expensive to be used in developing countries for vaccination programs. The recent progress in immunotherapy, biotechnology, recombinant DNA technology and molecular biology along with alternative and complementary medicinal systems have paved novel ways and valuable opportunities to design and develop effective prophylactic and therapeutic vaccines, drugs and treatment approach to counter HPV effectively. Exploration and more researches on such advances could result in the gradual reduction in the incidences of HPV cases across the world. The present review presents a current global scenario and futuristic prospects of the advanced prophylactic and therapeutic approaches against HPV along with recent patents coverage of the progress and advances in drugs, vaccines and therapeutic regimens to effectively combat HPV infections and its cancerous conditions.

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Reported adverse events in girls aged 13–16 years after vaccination with the human papillomavirus (HPV)-16/18 vaccine in the Netherlands

Cited by 23 publications

References 15 publications

Six‐year multi‐centre, observational, post‐marketing surveillance of the safety of the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 10–25 years in Korea

Six‐year multi‐centre, observational, post‐marketing surveillance of the safety of the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 10–25 years in Korea

Safety of human papillomavirus vaccines: a review

Advances in Designing and Developing Vaccines, Drugs and Therapeutic Approaches to Counter Human Papilloma Virus

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