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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

54516 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-29

Study Completion Date

2014-12-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021)

NCT02653118

Cervical Cancer Vulvar Cancer Vaginal Cancer +2 more

ACTIVE_NOT_RECRUITING

Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)

NCT00157950

Papillomavirus Infections

COMPLETED PHASE3

Effectiveness Study of Gardasil on Condyloma

NCT01553994

Condyloma Genital Warts

COMPLETED

Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)

NCT03158220

Cervical Cancer Vulvar Cancer Vaginal Cancer +2 more

COMPLETED PHASE3

GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046)

NCT01245764

Papillomavirus Infections

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Papillomavirus Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pre-Vaccine

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

No interventions assigned to this group

Post-Vaccine

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Inclusion Criteria: - Registry Data: \* Female residents of participating Nordic countries who 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 --Women 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes