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Vaccines

Registry, survey, and HPV status data from 2004-2006

Registry, survey, and HPV status data from 2011-2012

Medical Director

This study will assess the impact of GARDASIL™ human papillomavirus (HPV) vaccine in the general female population by utilizing nationwide registry databases in the participating Nordic countries.

Time perspective: The study will be conducted using data collected both retrospectively/concurrently from registries and prospectively by questionnaire survey.

Baseline survey data were collected during a prior study from 2004-2005.

Safety Monitoring: An expert panel on teratology consisting of one teratologist from each of the participating countries will review all available medical records related to any congenital anomalies to search for any emerging patterns that may be indicative of an association between GARDASIL™ exposure in the mother and the subsequent congenital anomalies in the babies.

GARDASIL™ Vaccine Impact in Population Study (V501-033)

GARDASIL™ Vaccine Impact in Population Study

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.

All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for women \<=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.

All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Denmark was recorded. Incidence rates are for women \>26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.

All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.

All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for women \<=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.

All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Norway was recorded. Incidence rates are for women \>26 years of age were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.

All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for all age groups and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.

All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for women \<=26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.

All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. The collection of such data in these registries is mandated by law and compliance is generally very high. The number of new cases of high-grade (2/3) CIN registered during the assessment periods in Sweden was recorded. Incidence rates are for women \>26 years of age and were age-adjusted using the European Standard Population. The incidence before Gardasil licensure is an average over the 3-year period.

All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related high-grade (2/3) CIN was estimated based on the proportion of HPV 6/11/16/18 in all CIN in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.

All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of high-grade (2/3) CIN related to high-risk HPV types other than 16 and 18 was analyzed. High-risk HPV types include 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Incidence was age-adjusted according to Nordic Standard Population.

All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The number of new cases of HPV 6/11/16/18-related cervical cancer was estimated based on the proportion of HPV 6/11/16/18 in all cervical cancers in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.

All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of new cases of cervical cancer associated with high-risk HPV types other than 16 and 18 was estimated based on the proportion of HPV 16/18 in all cervical cancer in a representative sample. Incidence was age-adjusted according to Nordic Standard Population.

The incidence of HPV-related histologically confirmed female genital diseases, including vulvar and vaginal cancer and their high-grade precursors was to be assessed.

All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for HPV 6, 11, 16, or 18 was analyzed.

All Nordic countries participating in this study have national cervical cancer screening programs and registry systems that routinely collect information on cervical cytology, histology, and/or definitive therapy results. In addition, lesional tissue samples were routinely collected and stored; the 2004 to 2006 period was chosen because it was sufficiently recent to reflect HPV type status immediately before licensure of Gardasil. The percentage of liquid-based cervical cytology samples positive for high-risk HPV Types other than 16 or 18, and not co-infected with Types 16 or 18, was analyzed.

The percentage of live born babies with major congenital anomalies (MCA) born to women vaccinated with Gardasil during pregnancy and to women in the general population was assessed. For Denmark and Sweden diagnoses of congenital anomaly within 1 year of birth are included; for Norway diagnoses at birth are included.

The incidence of CIN by Gardasil vaccination status was to be assessed.

The incidence of other cervical cancers by Gardasil vaccination status was to be assessed.

The incidence of other HPV-related genital diseases, including vulvar and vaginal cancers, by Gardasil vaccination status was to be assessed.

The percentage of participants with liquid-based cervical cytology samples positive for HPV 6, 11, 16, and 18 was to be analyzed by Gardasil vaccination status.

Danish Cancer Society

Union for International Cancer Control

Cancer Registry of Norway

Karolinska Institutet

Merck Sharp & Dohme LLC

Per protocol, adverse events were not collected as part of the study database; therefore, none were collected and the number at risk is zero

Denmark Participants

Norway Participants

Sweden Participants

Participants in Denmark who completed the first survey (before licensure of GARDASIL)

Participants in Norway who completed the first survey (before licensure of GARDASIL)

Participants in Sweden who completed the first survey (before licensure of GARDASIL)

Total

Age, Continuous

Sex: Female, Male

Participants who took the first survey given before Gardasil licensure

Senior Vice President, Global Clinical Development

Denmark Participants 2004 to 2006 Before Gardasil Licensure

Denmark Participants 2007, After Gardasil Licensure

Denmark Participants 2008 After Gardasil Licensure

Denmark Participants 2009 After Gardasil Licensure

Denmark Participants 2010 After Gardasil Licensure

Denmark Participants 2011 After Gardasil Licensure

The analysis population was the entire population of qualifying women in Denmark and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.

Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia (CIN) for Participants of All Ages in Denmark

The analysis population was the entire population of qualifying women \<=26 years of age in Denmark and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.

Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Denmark

The analysis population was the entire population of qualifying women \>26 years of age in Denmark and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.

Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Denmark

Norway Participants 2004 to 2006 Before Gardasil Licensure

Norway Participants 2007, After Gardasil Licensure

Norway Participants 2008 After Gardasil Licensure

Norway Participants 2009 After Gardasil Licensure

Norway Participants 2010 After Gardasil Licensure

Norway Participants 2011 After Gardasil Licensure

The analysis population was the entire population of qualifying women in Norway and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.

Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Norway

The analysis population was the entire population of qualifying women \<=26 years of age in Norway and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.

Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Norway

The analysis population was the entire population of women \>26 years of age in Norway and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.

Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Norway

Sweden Participants 2004 to 2006 Before Gardasil Licensure

Sweden Participants 2007, After Gardasil Licensure

Sweden Participants 2008 After Gardasil Licensure

Sweden Participants 2009 After Gardasil Licensure

Sweden Participants 2010 After Gardasil Licensure

Sweden Participants 2011 After Gardasil Licensure

The analysis population was the entire population of qualifying women in Sweden and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.

Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Sweden

The analysis population was the entire population of qualifying women \<=26 years of age in Sweden and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.

Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Sweden

The analysis population was the entire population of qualifying women \>26 years of age in Sweden and thus changed throughout the analysis. The number of participants analyzed given below is an estimate calculated from the number of reported cases and the incidence data.

Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Sweden

Overall CIN

HPV 6/11/16/18-related CIN

Denmark Participants 2011 to 2012 After Gardasil Licensure

Norway Participants 2011 to 2012 After Gardasil Licensure

Sweden Participants 2011 to 2012 After Gardasil Licensure

The analysis population was participants of all ages with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types

Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants of All Ages

The analysis population was participants \<=26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types

Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age

The analysis population was participants \>26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types

Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants >26 Years of Age

CIN not related to HPV 16/18

Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age

Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age

Overall cervical cancer

HPV 6/11/16/18-related cervical cancer

The analysis population was participants with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types

Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants of All Ages

The analysis population was participants \<=26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types

Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants <=26 Years of Age

The analysis population was participants \>26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types

Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants >26 Years of Age

Cervical cancer not related to HPV 16/18

Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age

Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age

Analysis of this endpoint was not planned nor were the data collected. Thus, the number of participants analyzed is zero.

Incidence of HPV-related Histologically Confirmed Female Genital Diseases, Including Vulvar and Vaginal Cancer and Their High-grade Precursors

The analysis population was participants \<=26 years of age with liquid-based cytology samples analyzed for HPV types

Prevalence of HPV 6/11/16/18 Infection in Participants <=26 Years of Age

The analysis population was participants \>26 years of age with liquid-based cytology samples analyzed for HPV types

Prevalence of HPV 6/11/16/18 Infection in Participants >26 Years of Age

Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants <=26 Years of Age

Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants >26 Years of Age

Live babies born between 2007 and 2011 to Denmark participants who received Gardasil during pregnancy

Babies Born to Denmark Participants Who Received Gardasil

Live babies born between 2007 and 2011 to Denmark participants in the general population, including participants who did and did not receive Gardasil

Babies Born to Denmark Participants

Live babies born between 2007 and 2011 to Norway participants who received Gardasil during pregnancy

Babies Born to Norway Participants Who Received Gardasil

Live babies born between 2007 and 2011 to Norway participants in the general population, including participants who did and did not receive Gardasil

Babies Born to Norway Participants

Live babies born between 2007 and 2011 to Sweden participants who received Gardasil during pregnancy

Babies Born to Sweden Participants Who Received Gardasil

Live babies born between 2007 and 2011 to Sweden participants in the general population, including participants who did and did not received Gardasil

Babies Born to Sweden Participants

The analysis population represents the babies born to participating mothers, instead of female participants, because the number of babies represents the denominator for the percentage calculation, not female participants (i.e., mothers)

Percentage of Live Born Babies With a Major Congenital Anomaly

Denmark participants who received Gardasil on or before March 2012

Denmark Participants Who Received Gardasil

Denmark Participants Who Did Not Receive Gardasil

Norway participants who received Gardasil on or before March 2012

Norway Participants Who Received Gardasil

Norway Participants Who Did Not Receive Gardasil

Sweden participants who received Gardasil on or before March 2012

Sweden Participants Who Received Gardasil

Sweden Participants Who Did Not Receive Gardasil

The analysis population was to be women who underwent cervical screening. A joint decision was made by the study team to forgo the stratified analysis by vaccination status because there were few women who had both been vaccinated with Gardasil and undergone cervical cancer screening. Thus, the number of participants analyzed is zero.

Incidence of Cervical Intraepithelial Neoplasia by Gardasil Vaccination Status

Incidence of Cervical Cancer by Gardasil Vaccination Status

Incidence of Other HPV-related Genital Diseases by Gardasil Vaccination Status

Prevalence of HPV 6, 11, 16, and 18 Infection by Gardasil Vaccination Status

Overall Study

Women with end-stage renal disease, whose eligibility for renal transplantation is assessed

Joanne A de Hullu, MD, PhD

The purpose of this study is to examine the prevalence, incidence and genotype of anogenital HPV infections in women before and after renal transplantation. With this information the investigators can determine the value of vaccination in patients waiting for renal transplantation in the future.

Each year about 800 renal transplantations are performed in the Netherlands. The current immunosuppressive strategies have led to a 1-year patient and graft survival of more than 90%. This high survival rate urges medical specialists to pay increasing attention to the long-term side effects of immunosuppressive medication, such as virus-associated cancers. An example of an oncogenic virus is the high risk Human Papillomavirus (hrHPV) which is related to (pre)malignancies of the anogenital tract e.g. cervix, vulva and anus. These malignancies are among the most common malignancies in renal transplant recipients (RTRs). The incidence of hrHPV-related cervical and vulvar malignancies is increased up to a 100-fold in RTRs compared to the general population. There is limited literature on the exact behaviour of HPV infection related anogenital (pre)malignancies in RTRs. A part of these (pre)malignancies are probably already present at the time of transplantation while others develop in the years after transplantation. With gynaecological examination the investigators can diagnose anogenital (pre)malignancies before transplantation so treatment, if necessary, can commence before transplantation. Knowledge about HPV status before and after transplantation gives insight in the natural course of the HPV infection in this group of patients and with this information the investigators can determine the value of vaccination in patients waiting for renal transplantation in the future.

Genital HPV Infections Before and After Renal Transplantation

The Incidence, Prevalence and Genotype of Genital Human Papillomavirus Infections in Females Before and After Renal Transplantation

The difference between post-transplantation prevalence (two HPV tests in 6 months after transplantation)and pre-transplantation prevalence (two HPV tests in 6 months before transplantation) will be compared.

Dutch Kidney Foundation

University Medical Center Nijmegen

MD, PhD

The participants who have already received 2 doses of the quadrivalent HPV vaccine (0, 6 months schedule) 5 years before recruitment will not receive an additional dose.

The participants will receive a 3rd dose of quadrivalent HPV vaccine at recruitment visit, which is 5 years after having received two doses of vaccine given 6 months apart in grade 4 (0, 6, 60 months Schedule)

One dose of Gardasil administered in the intervention group

Quadrivalent HPV vaccine

This randomised clinical trial aims to determine whether an immunization schedule comprising two doses of Gardasil administered six months apart is non-inferior to a schedule comprising three doses administered at 0, 6 and 60 months for the prevention of HPV-16 and HPV-18 infections that persist for at least six months, up to ten years after the initial vaccination.

The study hypothesis is that the two-dose schedule would offer similar protection as that of a three-dose schedule against persistent HPV-16/18 infections.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
GARDASIL™ Vaccine Impact in Population Study (V501-033)	NCT01077856	Human Papilloma...		18 Years - 45 Years	Merck Sharp & Dohme LLC
Genital HPV Infections Before and After Renal Transplantation	NCT01717443	Human Papilloma...		18 Years -	University Medical Center Nijmegen
ICI-VPH: Impact of HPV Immunisation Schedules Against HPV	NCT02009800	Human Papilloma...	Quadrivalent HP...	14 Years - 16 Years	CHU de Quebec-Universite Laval
Genital HPV Infections Before and After Renal Transplantation	NCT01717443	Human Papilloma...		18 Years -	University Medical Center Nijmegen

Spots Global Cancer Trial Database for human papillomavirus infections