N/A
N=54,516
GARDASIL™ Vaccine Impact in Population Study (V501-033)
Human Papillomavirus Infections
Bottom Line
View on ClinicalTrials.gov: NCT01077856 ↗Enrolled (actual)
54,516
Serious AEs
—
Results posted
Dec 2015
Primary outcome: Primary: Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia (CIN) for Participants of All Ages in Denmark — 164.2; 191.4; 217.7; 240.3 Cases per 100,000 women
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia (CIN) for Participants of All Ages in Denmark |
164.2; 191.4; 217.7; 240.3; 223.1; 228.8 | — |
| PRIMARY Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Denmark |
133.4; 162.2; 191.9; 233.6; 184.9; 201.5 | — |
| PRIMARY Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Denmark |
179.5; 206.0; 230.6; 243.9; 247.3; 246.1 | — |
| PRIMARY Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Norway |
133.3; 147.6; 145.0; 146.1; 147.1; 145.8 | — |
| PRIMARY Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Norway |
71.3; 75.0; 65.4; 70.2; 76.0; 71.3 | — |
| PRIMARY Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Norway |
172.6; 193.7; 195.4; 194.2; 192.3; 193.0 | — |
| PRIMARY Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Sweden |
142.6; 155.1; 170.1; 164.0; 168.1; 201.8 | — |
| PRIMARY Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Sweden |
94.1; 99.5; 130.1; 124.9; 127.5; 158.4 | — |
| PRIMARY Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Sweden |
140.8; 154.5; 195.1; 188.1; 201.5; 229.4 | — |
| PRIMARY Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants of All Ages |
164.2; 230.9; 133.3; 149.6; 142.6; 200.3 | — |
| PRIMARY Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age |
133.4; 198.6; 71.3; 76.1; 94.1; 156.8 | — |
| PRIMARY Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants >26 Years of Age |
179.5; 251.3; 172.6; 196.2; 140.8; 228.3 | — |
| PRIMARY Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age |
133.4; 198.6; 71.3; 76.1; 94.1; 156.8 | — |
| PRIMARY Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age |
179.5; 251.3; 172.6; 196.2; 140.8; 228.3 | — |
| PRIMARY Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants of All Ages |
13.8; 12.4; 11.7; 11.7; 8.4; 8.7 | — |
| PRIMARY Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants <=26 Years of Age |
2.6; 1.7; 0.9; 1.4; 0.8; 1.0 | — |
| PRIMARY Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants >26 Years of Age |
19.3; 19.2; 18.6; 18.2; 13.3; 13.6 | — |
| PRIMARY Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age |
2.6; 1.7; 0.9; 1.4; 0.8; 1.0 | — |
| PRIMARY Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age |
19.3; 19.2; 18.6; 18.2; 13.3; 13.6 | — |
| PRIMARY Incidence of HPV-related Histologically Confirmed Female Genital Diseases, Including Vulvar and Vaginal Cancer and Their High-grade Precursors |
— | — |
| PRIMARY Prevalence of HPV 6/11/16/18 Infection in Participants <=26 Years of Age |
20.3; 14.2; 26.7; 22.6; 19.0; 13.4 | — |
| PRIMARY Prevalence of HPV 6/11/16/18 Infection in Participants >26 Years of Age |
6.3; 4.7; 5.5; 6.2; 5.6; 7.7 | — |
| PRIMARY Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants <=26 Years of Age |
25.6; 22.8; 27.5; 23.5; 21.2; 24.6 | — |
| PRIMARY Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants >26 Years of Age |
12.6; 9.0; 9.6; 9.1; 9.0; 11.0 | — |
| PRIMARY Percentage of Live Born Babies With a Major Congenital Anomaly |
5.9; 4.4; 4.3; 2.9; 2.9; 3.0 | — |
| SECONDARY Incidence of Cervical Intraepithelial Neoplasia by Gardasil Vaccination Status |
— | — |
| SECONDARY Incidence of Cervical Cancer by Gardasil Vaccination Status |
— | — |
| SECONDARY Incidence of Other HPV-related Genital Diseases by Gardasil Vaccination Status |
— | — |
| SECONDARY Prevalence of HPV 6, 11, 16, and 18 Infection by Gardasil Vaccination Status |
— | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01077856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.