A summary of the post-licensure surveillance initiatives for GARDASIL/SILGARD®

Bonanni, Paolo; Cohet, Catherine; Kjær, Susanne K.; Latham, Nina B; Lambert, Paul‐Henri; Reisinger, Keith S.; Haupt, Richard M.

doi:10.1016/j.vaccine.2010.04.070

Cited by 59 publications

(30 citation statements)

References 18 publications

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“…In a review of reports to VAERS following quadrivalent HPV vaccine from June 1, 2006 through December 31, 2008, Slade et al [1] calculated a rate of 0.04 for transverse myelitis and 0.2 for Guillain-Barre syndrome (GBS) per 100,000 doses distributed, fi nding no evidence for disproportionate reporting of GBS after quadrivalent HPV vaccine as compared with GBS reported after other adolescent vaccines. Nevertheless, given the very low incidence of neurological AEFIs and the limitations of spontaneous reporting systems, including underreporting, unverifi ed reports and inconsistent data quality, large case -control studies such as the ongoing study using the French PGRx ® (Pharmacoepidemiological General Research) Program to assess the potential association between quadrivalent HPV vaccine and the occurrence of autoimmune/infl ammatory diseases, including GBS and other demyelinating diseases [12], are warranted to better clarify possible neurological AEFIs following the administration of HPV vaccines.…”

Section: Discussionmentioning

confidence: 99%

Bilateral Papilledema Following Human Papillomavirus Vaccination

Rossi

2011

J Med Cases

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Section: Discussionmentioning

confidence: 99%

Bilateral Papilledema Following Human Papillomavirus Vaccination

Rossi

2011

J Med Cases

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“…Therefore, the evaluation of vaccine safety during pregnancy has been undertaken by manufacturers through pregnancy registries and in post-marketing safety studies. 16,17 By contrast, pandemic H1N1 influenza vaccines were recommended for pregnant women who are at high risk for severe influenza. Because of the speed of the pandemic there was not sufficient time to conduct clinical studies in pregnant women, but vaccination was recommended in this group because of the high attendant risk associated with H1N1 infection.…”

Section: Vaccines Containing Adjuvants: Key Features That Guide Safetmentioning

confidence: 99%

Safety assessment of adjuvanted vaccines: Methodological considerations

Silva¹,

Pasquale²,

Yarzábal³

et al. 2015

Human Vaccines & Immunotherapeutics

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Adjuvants mainly interact with the innate immune response and are used to enhance the quantity and quality of the downstream adaptive immune response to vaccine antigens. Establishing the safety of a new adjuvant-antigen combination is achieved through rigorous evaluation that begins in the laboratory, and that continues throughout the vaccine life-cycle. The strategy for the evaluation of safety pre-licensure is guided by the disease profile, vaccine indication, and target population, and it is also influenced by available regulatory guidelines. In order to allow meaningful interpretation of clinical data, clinical program methodology should be optimized and standardized, making best use of all available data sources. Post-licensure safety activities are directed by field experience accumulated pre-and postlicensure clinical trial data and spontaneous adverse event reports. Continued evolution of safety evaluation processes that keep pace with advances in vaccine technology and updated communication of the benefit-risk profile is necessary to maintain public confidence in vaccines.

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“…[31][32][33][34] • The quadrivalent HPV vaccine was generally well tolerated in males aged 9-26 years; the most common adverse events (evaluated using vaccination report cardaided surveillance) were injection-site related. [21][22][23] The most frequent (≥5% of vaccine recipients and more frequent than in placebo [either AAHS control or saline] recipients) injection-site reactions across all age groups (pooled data) on days 1-5 postinjection were pain (61.5% of vaccine recipients vs 50.8% of AAHS control and 41.6% of saline recipients), erythema (16.7% vs 14.1% and 14.5%) and swelling (13.9% vs 9.6% and 8.2%).…”

Section: Tolerabilitymentioning

confidence: 99%

Quadrivalent Human Papillomavirus (HPV) Types 6, 11, 16, 18 Vaccine for the Prevention of Genital Warts in Males

Garnock-Jones¹,

Giuliano

2012

Drugs R D

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The quadrivalent HPV types 6, 11, 16, 18 vaccine (Gardasil ® ) is a recombinant vaccine comprising purified virus-like particles derived from the L1 capsid proteins of HPV types 6, 11, 16 and 18.The vaccine was highly immunogenic. Geometric mean titres (GMTs) and seroconversion rates for all four HPV types at month 7 in males aged 10-15 years were noninferior to those in females aged 16-23 years, and those in males aged 9-15 years were noninferior to those in females aged 9-15 years. In addition, GMTs and seroconversion rates in males aged 16-26 years receiving the vaccine were higher than those receiving amorphous aluminium hydroxyphosphate sulfate adjuvant (AAHS) control.The quadrivalent HPV vaccine was significantly more effective than AAHS control at decreasing the incidence of HPV 6-, 11-, 16-or 18-related external genital lesions (primary endpoint) in a randomized, double-blind, placebo-controlled, multicentre study in males aged 16-26 years. The most common clinical endpoint was HPV 6-and 11-related condyloma; efficacy was robust against these lesions.The vaccine is also expected to be protective against genital warts in males aged 9-15 years, as the immune response in males of this age group was noninferior to that in males aged 16-26 years.The quadrivalent HPV vaccine was generally well tolerated in males aged 9-26 years. The most common adverse events reported were injection-site related, and most of these were of mild to moderate severity.Correspondence: Karly P. Garnock-Jones, Adis, a Wolters Kluwer Business, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore 0754, Auckland, New Zealand. demail@adis.co.nz. DisclosuresThe preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made on the basis of scientific and editorial merit. HHS Public Access Author manuscriptDrugs. Author manuscript; available in PMC 2015 November 11. Published in final edited form as:Drugs. 2011 March 26; 71(5): 591-602. doi:10.2165/11205980-000000000-00000. Author Manuscript Author ManuscriptAuthor Manuscript Author ManuscriptFeatures and properties of the quadrivalent human papillomavirus (HPV) types 6, 11, 16, 18 vaccine (Gardasil®) Featured indicationPrevention of genital warts (condyloma acuminata) caused by infection with HPV types 6 and 11 in males aged 9-26 y Vaccine compositionVirus-like particles (VLPs) derived from the L1 capsid proteins of HPV types 6, 11, 16 and 18Formulated with a proprietary amorphous aluminium hydroxyphosphate sulfate adjuvant (225 μg per dose) Dosage and administrationRoute of administration Intramuscular injection Dose 0.5 mL (containing 20, 40, 40 and 20 μg of VLPs for HPV types 6, 11, 16 and 18, respectively)Administration schedule Three-dose regimen; injections at months 0, 2 and 6Most common adverse events (≥5% of males aged 9-26 years receiving the quadrivalent HPV vaccine)Injectio...

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A summary of the post-licensure surveillance initiatives for GARDASIL/SILGARD®

Cited by 59 publications

References 18 publications

Bilateral Papilledema Following Human Papillomavirus Vaccination

Bilateral Papilledema Following Human Papillomavirus Vaccination

Safety assessment of adjuvanted vaccines: Methodological considerations

Quadrivalent Human Papillomavirus (HPV) Types 6, 11, 16, 18 Vaccine for the Prevention of Genital Warts in Males

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