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NCT01077856: VIP

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

Completed Results posted Last updated 13 September 2022
What this trial tests

trial in Human Papillomavirus Infections in 54,516 participants. Completed in 2 December 2014.

Timeline
29 May 2007
Primary endpoint
2 December 2014
2 December 2014

Quick facts

Lead sponsorMerck Sharp & Dohme LLC
StatusCompleted
Study typeOBSERVATIONAL
Enrollment54,516
Start date29 May 2007
Primary completion2 December 2014
Estimated completion2 December 2014

Conditions studied

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 45, female only, with Human Papillomavirus Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia (CIN) for Participants of All Ages in Denmark Primary · Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)

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 ove

GroupValue95% CI
Denmark Participants 2004 to 2006 Before Gardasil Licensure164.2
Denmark Participants 2007, After Gardasil Licensure191.4
Denmark Participants 2008 After Gardasil Licensure217.7
Denmark Participants 2009 After Gardasil Licensure240.3
Denmark Participants 2010 After Gardasil Licensure223.1
Denmark Participants 2011 After Gardasil Licensure228.8
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Denmark Primary · Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)

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 a

GroupValue95% CI
Denmark Participants 2004 to 2006 Before Gardasil Licensure133.4
Denmark Participants 2007, After Gardasil Licensure162.2
Denmark Participants 2008 After Gardasil Licensure191.9
Denmark Participants 2009 After Gardasil Licensure233.6
Denmark Participants 2010 After Gardasil Licensure184.9
Denmark Participants 2011 After Gardasil Licensure201.5
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Denmark Primary · Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)

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 av

GroupValue95% CI
Denmark Participants 2004 to 2006 Before Gardasil Licensure179.5
Denmark Participants 2007, After Gardasil Licensure206.0
Denmark Participants 2008 After Gardasil Licensure230.6
Denmark Participants 2009 After Gardasil Licensure243.9
Denmark Participants 2010 After Gardasil Licensure247.3
Denmark Participants 2011 After Gardasil Licensure246.1
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Norway Primary · Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)

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

GroupValue95% CI
Norway Participants 2004 to 2006 Before Gardasil Licensure133.3
Norway Participants 2007, After Gardasil Licensure147.6
Norway Participants 2008 After Gardasil Licensure145.0
Norway Participants 2009 After Gardasil Licensure146.1
Norway Participants 2010 After Gardasil Licensure147.1
Norway Participants 2011 After Gardasil Licensure145.8
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Norway Primary · Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)

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 av

GroupValue95% CI
Norway Participants 2004 to 2006 Before Gardasil Licensure71.3
Norway Participants 2007, After Gardasil Licensure75.0
Norway Participants 2008 After Gardasil Licensure65.4
Norway Participants 2009 After Gardasil Licensure70.2
Norway Participants 2010 After Gardasil Licensure76.0
Norway Participants 2011 After Gardasil Licensure71.3
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Norway Primary · Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)

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

GroupValue95% CI
Norway Participants 2004 to 2006 Before Gardasil Licensure172.6
Norway Participants 2007, After Gardasil Licensure193.7
Norway Participants 2008 After Gardasil Licensure195.4
Norway Participants 2009 After Gardasil Licensure194.2
Norway Participants 2010 After Gardasil Licensure192.3
Norway Participants 2011 After Gardasil Licensure193.0
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Sweden Primary · Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)

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

GroupValue95% CI
Sweden Participants 2004 to 2006 Before Gardasil Licensure142.6
Sweden Participants 2007, After Gardasil Licensure155.1
Sweden Participants 2008 After Gardasil Licensure170.1
Sweden Participants 2009 After Gardasil Licensure164.0
Sweden Participants 2010 After Gardasil Licensure168.1
Sweden Participants 2011 After Gardasil Licensure201.8
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Sweden Primary · Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)

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 av

GroupValue95% CI
Sweden Participants 2004 to 2006 Before Gardasil Licensure94.1
Sweden Participants 2007, After Gardasil Licensure99.5
Sweden Participants 2008 After Gardasil Licensure130.1
Sweden Participants 2009 After Gardasil Licensure124.9
Sweden Participants 2010 After Gardasil Licensure127.5
Sweden Participants 2011 After Gardasil Licensure158.4
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Sweden Primary · Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)

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 ave

GroupValue95% CI
Sweden Participants 2004 to 2006 Before Gardasil Licensure140.8
Sweden Participants 2007, After Gardasil Licensure154.5
Sweden Participants 2008 After Gardasil Licensure195.1
Sweden Participants 2009 After Gardasil Licensure188.1
Sweden Participants 2010 After Gardasil Licensure201.5
Sweden Participants 2011 After Gardasil Licensure229.4
Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants of All Ages Primary · Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)

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.

Overall CIN
GroupValue95% CI
Denmark Participants 2004 to 2006 Before Gardasil Licensure164.20.6 – 4.0
Denmark Participants 2011 to 2012 After Gardasil Licensure230.90.0 – 1.8
Norway Participants 2004 to 2006 Before Gardasil Licensure133.30.0 – 1.9
Norway Participants 2011 to 2012 After Gardasil Licensure149.60.0 – 1.8
Sweden Participants 2004 to 2006 Before Gardasil Licensure142.60.3 – 2.6
Sweden Participants 2011 to 2012 After Gardasil Licensure200.30.2 – 2.9
HPV 6/11/16/18-related CIN
GroupValue95% CI
Denmark Participants 2004 to 2006 Before Gardasil Licensure80.6
Denmark Participants 2011 to 2012 After Gardasil Licensure115.0
Norway Participants 2004 to 2006 Before Gardasil Licensure70.1
Norway Participants 2011 to 2012 After Gardasil Licensure75.1
Sweden Participants 2004 to 2006 Before Gardasil Licensure73.9
Sweden Participants 2011 to 2012 After Gardasil Licensure106.2
Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age Primary · Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)

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.

Overall CIN
GroupValue95% CI
Denmark Participants 2004 to 2006 Before Gardasil Licensure133.40.6 – 4.0
Denmark Participants 2011 to 2012 After Gardasil Licensure198.60.0 – 1.8
Norway Participants 2004 to 2006 Before Gardasil Licensure71.30.0 – 1.9
Norway Participants 2011 to 2012 After Gardasil Licensure76.10.0 – 1.8
Sweden Participants 2004 to 2006 Before Gardasil Licensure94.10.3 – 2.6
Sweden Participants 2011 to 2012 After Gardasil Licensure156.80.2 – 2.9
HPV 6/11/16/18-related CIN
GroupValue95% CI
Denmark Participants 2004 to 2006 Before Gardasil Licensure72.2
Denmark Participants 2011 to 2012 After Gardasil Licensure117.2
Norway Participants 2004 to 2006 Before Gardasil Licensure50.9
Norway Participants 2011 to 2012 After Gardasil Licensure41.6
Sweden Participants 2004 to 2006 Before Gardasil Licensure56.6
Sweden Participants 2011 to 2012 After Gardasil Licensure102.9
Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants >26 Years of Age Primary · Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)

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.

Overall CIN
GroupValue95% CI
Denmark Participants 2004 to 2006 Before Gardasil Licensure179.50.6 – 4.0
Denmark Participants 2011 to 2012 After Gardasil Licensure251.30.0 – 1.8
Norway Participants 2004 to 2006 Before Gardasil Licensure172.60.0 – 1.9
Norway Participants 2011 to 2012 After Gardasil Licensure196.20.0 – 1.8
Sweden Participants 2004 to 2006 Before Gardasil Licensure140.80.3 – 2.6
Sweden Participants 2011 to 2012 After Gardasil Licensure228.30.2 – 2.9
HPV 6/11/16/18-related CIN
GroupValue95% CI
Denmark Participants 2004 to 2006 Before Gardasil Licensure85.1
Denmark Participants 2011 to 2012 After Gardasil Licensure114.3
Norway Participants 2004 to 2006 Before Gardasil Licensure85.3
Norway Participants 2011 to 2012 After Gardasil Licensure97.3
Sweden Participants 2004 to 2006 Before Gardasil Licensure68.7
Sweden Participants 2011 to 2012 After Gardasil Licensure108.2

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Human papillomavirus genotype-specific risks for cervical intraepithelial lesions.
    Nygård M, Hansen BT, Kjaer SK, Hortlund M, et al · · 2021 · cited 22× · PMID 32990181 · DOI 10.1080/21645515.2020.1814097
  2. Exploring the Intricacies of Cervical Intraepithelial Neoplasia and Its Connection with HPV: A Narrative Review.
    Karimi P, Reza Hosseini SM, Mousavian Hiagh ZS, Aboulhassanzadeh S, et al · · 2024 · cited 4× · PMID 39759206 · DOI 10.18502/ijph.v53i12.17310

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing