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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Danish Cancer Society
Union for International Cancer Control
The Cancer Registry of Norway
Karolinska Institutet
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01077856
First received: February 26, 2010
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

This study will assess the impact of GARDASIL™ in the general female population by utilizing nationwide registry databases in the participating Nordic countries.


Condition
Human Papillomavirus Infections

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Official Title: GARDASIL™ Vaccine Impact in Population Study

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Incidence of histologically confirmed cervical intraepithelial neoplasia (CIN) [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Incidence of HPV 6-related histologically confirmed high-grade CIN [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Incidence of HPV 11-related histologically confirmed high-grade CIN [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Incidence of HPV 16-related histologically confirmed high-grade CIN [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Incidence of HPV 18-related histologically confirmed high-grade CIN [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Incidence of HPV 6-related histologically confirmed cervical cancer [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Incidence of HPV 11-related histologically confirmed cervical cancer [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Incidence of HPV 16-related histologically confirmed cervical cancer [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Incidence of HPV 18-related histologically confirmed cervical cancer [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Incidence of incidence of histologically confirmed high-grade CIN related to high-risk HPV types other than 6/11/16/18 [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Incidence of incidence of histologically confirmed cervical cancer related to high-risk HPV types other than 6/11/16/18 [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Incidence of other HPV-related histologically confirmed female genital diseases, including vulvar and vaginal cancers and their high-grade precursors [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Prevalence of HPV 6 infection in general female population [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Prevalence of HPV 11 infection in general female population [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Prevalence of HPV 16 infection in general female population [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Prevalence of HPV 18 infection in general female population [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Prevalence of HPV infection with high-risk types other than 16 and 18 [ Time Frame: 2004-2006 and 2011-2012 ] [ Designated as safety issue: No ]
  • Standardized incidence ratio of observed and expected congenital anomalies in women exposed to GARDASIL™ during pregnancy [ Time Frame: 2011-2012 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of CIN in recipients of GARDASIL™ in 2011-2012 [ Time Frame: 2011-2012 ] [ Designated as safety issue: No ]
  • Incidence of CIN in non-recipients of GARDASIL™ in 2011-2012 [ Time Frame: 2011-2012 ] [ Designated as safety issue: No ]
  • Incidence of cervical cancer in recipients of GARDASIL™ in 2011-2012 [ Time Frame: 2011-2012 ] [ Designated as safety issue: No ]
  • Incidence of cervical cancer in non-recipients of GARDASIL™ in 2011-2012 [ Time Frame: 2011-2012 ] [ Designated as safety issue: No ]
  • Incidence of other HPV-related genital diseases, including vulvar and vaginal cancers, in recipients of GARDASIL™ in 2011-2012 [ Time Frame: 2011-2012 ] [ Designated as safety issue: No ]
  • Incidence of other HPV-related genital diseases, including vulvar and vaginal cancers, in non-recipients of GARDASIL™ in 2011-2012 [ Time Frame: 2011-2012 ] [ Designated as safety issue: No ]
  • Prevalence of HPV 6 infection in recipients of GARDASIL™ in 2011-2012 [ Time Frame: 2011-2012 ] [ Designated as safety issue: No ]
  • Prevalence of HPV 6 infection in non-recipients of GARDASIL™ in 2011-2012 [ Time Frame: 2011-2012 ] [ Designated as safety issue: No ]
  • Prevalence of HPV 11 infection in recipients of GARDASIL™ in 2011-2012 [ Time Frame: 2011-2012 ] [ Designated as safety issue: No ]
  • Prevalence of HPV 11 infection in non-recipients of GARDASIL™ in 2011-2012 [ Time Frame: 2011-2012 ] [ Designated as safety issue: No ]
  • Prevalence of HPV 16 infection in recipients of GARDASIL™ in 2011-2012 [ Time Frame: 2011-2012 ] [ Designated as safety issue: No ]
  • Prevalence of HPV 16 infection in non-recipients of GARDASIL™ in 2011-2012 [ Time Frame: 2011-2012 ] [ Designated as safety issue: No ]
  • Prevalence of HPV 18 infection in recipients of GARDASIL™ in 2011-2012 [ Time Frame: 2011-2012 ] [ Designated as safety issue: No ]
  • Prevalence of HPV 18 infection in non-recipients of GARDASIL™ in 2011-2012 [ Time Frame: 2011-2012 ] [ Designated as safety issue: No ]
  • Prevalence of HPV infection due to high-risk types other than 16 and 18 in recipients of GARDASIL™ in 2011-2012 [ Time Frame: 2011-2012 ] [ Designated as safety issue: No ]
  • Prevalence of HPV infection due to high-risk types other than 16 and 18 in non-recipients of GARDASIL™ in 2011-2012 [ Time Frame: 2011-2012 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tissue, cervical cells


Estimated Enrollment: 56000
Study Start Date: May 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pre-Vaccine
Registry, survey, and HPV status data from 2004-2006
Post-Vaccine
Registry, survey, and HPV status data from 2011-2012

Detailed Description:

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.

Enrollment/Sample Size: Registry Data: All appropriate data will be used; Survey Data: for each country: 14,000; HPV Data: 2,500 cervical swab samples and 500 tissue samples.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Registry data from the Population, Cervical Cancer Screening, Pathology, Cancer, and Death registries; Survey: Questionnaire sent to random sampling of women from the Central Population Registry Database; HPV Data: liquid-based cytology and histology samples from hospitals in participating countries

Criteria

Inclusion Criteria:

  • Registry Data:

    • Female residents of participating Nordic countries who are/were alive on January 1st in the year the data will be used for analysis
  • Survey Data:

    • Female residents alive in the participating countries on July 1, 2011
    • Subjects must provide consent to use questionnaire data and to link data to other registry databases
  • Cervical Sample Collection:

    • For HPV data in the general population: cervical samples from residents of the participating countries who are 45 years and under collected between 2006 and 2007, or in 2011-2012
    • For HPV data in lesional samples: cervical samples from women with a diagnosis of CIN or cervical cancer between 2004-2006 and 2011-2012

Exclusion Criteria:

  • Registry Data:

    • Women who participated in Protocol V501-015 (NCT00092534) and are included in the Long-Term Follow-Up study
  • Survey Data:

    • Women under 18 or above age 45 on July 1, 2011
    • Women who participated in Protocol V501-015 and are included in the Long-Term Follow-Up study
  • Cervical Sample Collection:

    • Samples from women who participated in Protocol V501-015 and are included in the Long-Term Follow-Up study
    • Samples with inadequate integrity for HPV testing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077856

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Danish Cancer Society
Union for International Cancer Control
The Cancer Registry of Norway
Karolinska Institutet
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01077856     History of Changes
Other Study ID Numbers: V501-033, 2010_018, EP08014.033
Study First Received: February 26, 2010
Last Updated: September 9, 2014
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Merck Sharp & Dohme Corp.:
congenital anomaly
pregnancy
GARDASIL®
Nordic
population-based

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Tumor Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014