Trial Outcomes & Findings for GARDASIL™ Vaccine Impact in Population Study (V501-033) (NCT NCT01077856)
NCT ID: NCT01077856
Last Updated: 2022-09-13
Results Overview
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.
COMPLETED
54516 participants
Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)
2022-09-13
Participant Flow
Participant milestones
| Measure |
Denmark Participants
Participants in Denmark who completed the first survey (before licensure of GARDASIL)
|
Norway Participants
Participants in Norway who completed the first survey (before licensure of GARDASIL)
|
Sweden Participants
Participants in Sweden who completed the first survey (before licensure of GARDASIL)
|
|---|---|---|---|
|
Overall Study
STARTED
|
22199
|
16604
|
15713
|
|
Overall Study
COMPLETED
|
22199
|
16604
|
15713
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GARDASIL™ Vaccine Impact in Population Study (V501-033)
Baseline characteristics by cohort
| Measure |
Denmark Participants
n=22199 Participants
Participants in Denmark who completed the first survey (before licensure of GARDASIL)
|
Norway Participants
n=16604 Participants
Participants in Norway who completed the first survey (before licensure of GARDASIL)
|
Sweden Participants
n=15713 Participants
Participants in Sweden who completed the first survey (before licensure of GARDASIL)
|
Total
n=54516 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.9 Years
n=5 Participants
|
31.0 Years
n=7 Participants
|
33.2 Years
n=5 Participants
|
32.0 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
22199 Participants
n=5 Participants
|
16604 Participants
n=7 Participants
|
15713 Participants
n=5 Participants
|
54516 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)Population: 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.
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=4156 cases
|
Denmark Participants 2007, After Gardasil Licensure
n=4827 cases
|
Denmark Participants 2008 After Gardasil Licensure
n=5463 cases
|
Denmark Participants 2009 After Gardasil Licensure
n=6041 cases
|
Denmark Participants 2010 After Gardasil Licensure
n=5587 cases
|
Denmark Participants 2011 After Gardasil Licensure
n=5709 cases
|
|---|---|---|---|---|---|---|
|
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia (CIN) for Participants of All Ages in Denmark
|
164.2 Cases per 100,000 women
|
191.4 Cases per 100,000 women
|
217.7 Cases per 100,000 women
|
240.3 Cases per 100,000 women
|
223.1 Cases per 100,000 women
|
228.8 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)Population: 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.
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=949 cases
|
Denmark Participants 2007, After Gardasil Licensure
n=1146 cases
|
Denmark Participants 2008 After Gardasil Licensure
n=1345 cases
|
Denmark Participants 2009 After Gardasil Licensure
n=1654 cases
|
Denmark Participants 2010 After Gardasil Licensure
n=1615 cases
|
Denmark Participants 2011 After Gardasil Licensure
n=1811 cases
|
|---|---|---|---|---|---|---|
|
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Denmark
|
133.4 Cases per 100,000 women
|
162.2 Cases per 100,000 women
|
191.9 Cases per 100,000 women
|
233.6 Cases per 100,000 women
|
184.9 Cases per 100,000 women
|
201.5 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)Population: 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.
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=3207 cases
|
Denmark Participants 2007, After Gardasil Licensure
n=3681 cases
|
Denmark Participants 2008 After Gardasil Licensure
n=4118 cases
|
Denmark Participants 2009 After Gardasil Licensure
n=4387 cases
|
Denmark Participants 2010 After Gardasil Licensure
n=3972 cases
|
Denmark Participants 2011 After Gardasil Licensure
n=3898 cases
|
|---|---|---|---|---|---|---|
|
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Denmark
|
179.5 Cases per 100,000 women
|
206.0 Cases per 100,000 women
|
230.6 Cases per 100,000 women
|
243.9 Cases per 100,000 women
|
247.3 Cases per 100,000 women
|
246.1 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)Population: 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.
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=3006 cases
|
Denmark Participants 2007, After Gardasil Licensure
n=3344 cases
|
Denmark Participants 2008 After Gardasil Licensure
n=3305 cases
|
Denmark Participants 2009 After Gardasil Licensure
n=3364 cases
|
Denmark Participants 2010 After Gardasil Licensure
n=3418 cases
|
Denmark Participants 2011 After Gardasil Licensure
n=3431 cases
|
|---|---|---|---|---|---|---|
|
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Norway
|
133.3 Cases per 100,000 women
|
147.6 Cases per 100,000 women
|
145.0 Cases per 100,000 women
|
146.1 Cases per 100,000 women
|
147.1 Cases per 100,000 women
|
145.8 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)Population: 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.
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=543 cases
|
Denmark Participants 2007, After Gardasil Licensure
n=580 cases
|
Denmark Participants 2008 After Gardasil Licensure
n=516 cases
|
Denmark Participants 2009 After Gardasil Licensure
n=566 cases
|
Denmark Participants 2010 After Gardasil Licensure
n=627 cases
|
Denmark Participants 2011 After Gardasil Licensure
n=609 cases
|
|---|---|---|---|---|---|---|
|
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Norway
|
71.3 Cases per 100,000 women
|
75.0 Cases per 100,000 women
|
65.4 Cases per 100,000 women
|
70.2 Cases per 100,000 women
|
76.0 Cases per 100,000 women
|
71.3 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)Population: 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.
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=2463 cases
|
Denmark Participants 2007, After Gardasil Licensure
n=2764 cases
|
Denmark Participants 2008 After Gardasil Licensure
n=2789 cases
|
Denmark Participants 2009 After Gardasil Licensure
n=2798 cases
|
Denmark Participants 2010 After Gardasil Licensure
n=2791 cases
|
Denmark Participants 2011 After Gardasil Licensure
n=2822 cases
|
|---|---|---|---|---|---|---|
|
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Norway
|
172.6 Cases per 100,000 women
|
193.7 Cases per 100,000 women
|
195.4 Cases per 100,000 women
|
194.2 Cases per 100,000 women
|
192.3 Cases per 100,000 women
|
193.0 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)Population: 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.
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=5971 cases
|
Denmark Participants 2007, After Gardasil Licensure
n=6496 cases
|
Denmark Participants 2008 After Gardasil Licensure
n=7143 cases
|
Denmark Participants 2009 After Gardasil Licensure
n=6959 cases
|
Denmark Participants 2010 After Gardasil Licensure
n=7451 cases
|
Denmark Participants 2011 After Gardasil Licensure
n=8793 cases
|
|---|---|---|---|---|---|---|
|
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants of All Ages in Sweden
|
142.6 Cases per 100,000 women
|
155.1 Cases per 100,000 women
|
170.1 Cases per 100,000 women
|
164.0 Cases per 100,000 women
|
168.1 Cases per 100,000 women
|
201.8 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)Population: 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.
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=1375 cases
|
Denmark Participants 2007, After Gardasil Licensure
n=1455 cases
|
Denmark Participants 2008 After Gardasil Licensure
n=2014 cases
|
Denmark Participants 2009 After Gardasil Licensure
n=2005 cases
|
Denmark Participants 2010 After Gardasil Licensure
n=2133 cases
|
Denmark Participants 2011 After Gardasil Licensure
n=2732 cases
|
|---|---|---|---|---|---|---|
|
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age in Sweden
|
94.1 Cases per 100,000 women
|
99.5 Cases per 100,000 women
|
130.1 Cases per 100,000 women
|
124.9 Cases per 100,000 women
|
127.5 Cases per 100,000 women
|
158.4 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006 combined) and annually after Gardasil licensure (2007, 2008, 2009, 2010, and 2011)Population: 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.
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=4596 cases
|
Denmark Participants 2007, After Gardasil Licensure
n=5041 cases
|
Denmark Participants 2008 After Gardasil Licensure
n=5129 cases
|
Denmark Participants 2009 After Gardasil Licensure
n=4945 cases
|
Denmark Participants 2010 After Gardasil Licensure
n=5318 cases
|
Denmark Participants 2011 After Gardasil Licensure
n=6061 cases
|
|---|---|---|---|---|---|---|
|
Incidence of Histologically-confirmed Cervical Intraepithelial Neoplasia for Participants >26 Years of Age in Sweden
|
140.8 Cases per 100,000 women
|
154.5 Cases per 100,000 women
|
195.1 Cases per 100,000 women
|
188.1 Cases per 100,000 women
|
201.5 Cases per 100,000 women
|
229.4 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)Population: The analysis population was participants of all ages with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=289 Participants
|
Denmark Participants 2007, After Gardasil Licensure
n=311 Participants
|
Denmark Participants 2008 After Gardasil Licensure
n=285 Participants
|
Denmark Participants 2009 After Gardasil Licensure
n=299 Participants
|
Denmark Participants 2010 After Gardasil Licensure
n=390 Participants
|
Denmark Participants 2011 After Gardasil Licensure
n=304 Participants
|
|---|---|---|---|---|---|---|
|
Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants of All Ages
Overall CIN
|
164.2 Cases per 100,000 women
Interval 0.6 to 4.0
|
230.9 Cases per 100,000 women
Interval 0.0 to 1.8
|
133.3 Cases per 100,000 women
Interval 0.0 to 1.9
|
149.6 Cases per 100,000 women
Interval 0.0 to 1.8
|
142.6 Cases per 100,000 women
Interval 0.3 to 2.6
|
200.3 Cases per 100,000 women
Interval 0.2 to 2.9
|
|
Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants of All Ages
HPV 6/11/16/18-related CIN
|
80.6 Cases per 100,000 women
|
115.0 Cases per 100,000 women
|
70.1 Cases per 100,000 women
|
75.1 Cases per 100,000 women
|
73.9 Cases per 100,000 women
|
106.2 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)Population: The analysis population was participants \<=26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=74 Participants
|
Denmark Participants 2007, After Gardasil Licensure
n=100 Participants
|
Denmark Participants 2008 After Gardasil Licensure
n=42 Participants
|
Denmark Participants 2009 After Gardasil Licensure
n=33 Participants
|
Denmark Participants 2010 After Gardasil Licensure
n=103 Participants
|
Denmark Participants 2011 After Gardasil Licensure
n=93 Participants
|
|---|---|---|---|---|---|---|
|
Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age
Overall CIN
|
133.4 Cases per 100,000 women
Interval 0.6 to 4.0
|
198.6 Cases per 100,000 women
Interval 0.0 to 1.8
|
71.3 Cases per 100,000 women
Interval 0.0 to 1.9
|
76.1 Cases per 100,000 women
Interval 0.0 to 1.8
|
94.1 Cases per 100,000 women
Interval 0.3 to 2.6
|
156.8 Cases per 100,000 women
Interval 0.2 to 2.9
|
|
Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants <=26 Years of Age
HPV 6/11/16/18-related CIN
|
72.2 Cases per 100,000 women
|
117.2 Cases per 100,000 women
|
50.9 Cases per 100,000 women
|
41.6 Cases per 100,000 women
|
56.6 Cases per 100,000 women
|
102.9 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)Population: The analysis population was participants \>26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=215 Participants
|
Denmark Participants 2007, After Gardasil Licensure
n=211 Participants
|
Denmark Participants 2008 After Gardasil Licensure
n=243 Participants
|
Denmark Participants 2009 After Gardasil Licensure
n=266 Participants
|
Denmark Participants 2010 After Gardasil Licensure
n=287 Participants
|
Denmark Participants 2011 After Gardasil Licensure
n=211 Participants
|
|---|---|---|---|---|---|---|
|
Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants >26 Years of Age
Overall CIN
|
179.5 Cases per 100,000 women
Interval 0.6 to 4.0
|
251.3 Cases per 100,000 women
Interval 0.0 to 1.8
|
172.6 Cases per 100,000 women
Interval 0.0 to 1.9
|
196.2 Cases per 100,000 women
Interval 0.0 to 1.8
|
140.8 Cases per 100,000 women
Interval 0.3 to 2.6
|
228.3 Cases per 100,000 women
Interval 0.2 to 2.9
|
|
Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia for Participants >26 Years of Age
HPV 6/11/16/18-related CIN
|
85.1 Cases per 100,000 women
|
114.3 Cases per 100,000 women
|
85.3 Cases per 100,000 women
|
97.3 Cases per 100,000 women
|
68.7 Cases per 100,000 women
|
108.2 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)Population: The analysis population was participants \<=26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=74 Participants
|
Denmark Participants 2007, After Gardasil Licensure
n=100 Participants
|
Denmark Participants 2008 After Gardasil Licensure
n=42 Participants
|
Denmark Participants 2009 After Gardasil Licensure
n=33 Participants
|
Denmark Participants 2010 After Gardasil Licensure
n=103 Participants
|
Denmark Participants 2011 After Gardasil Licensure
n=93 Participants
|
|---|---|---|---|---|---|---|
|
Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age
Overall CIN
|
133.4 Cases per 100,000 women
Interval 30.8 to 42.3
|
198.6 Cases per 100,000 women
Interval 32.5 to 43.6
|
71.3 Cases per 100,000 women
Interval 26.6 to 37.7
|
76.1 Cases per 100,000 women
Interval 30.7 to 41.8
|
94.1 Cases per 100,000 women
Interval 32.1 to 41.9
|
156.8 Cases per 100,000 women
Interval 29.8 to 40.9
|
|
Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age
CIN not related to HPV 16/18
|
46.8 Cases per 100,000 women
|
67.5 Cases per 100,000 women
|
17.0 Cases per 100,000 women
|
30.0 Cases per 100,000 women
|
34.7 Cases per 100,000 women
|
45.5 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)Population: The analysis population was participants \>26 years of age with newly-diagnosed high-grade CIN and lesional tissue samples analyzed for HPV types
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=215 Participants
|
Denmark Participants 2007, After Gardasil Licensure
n=211 Participants
|
Denmark Participants 2008 After Gardasil Licensure
n=243 Participants
|
Denmark Participants 2009 After Gardasil Licensure
n=266 Participants
|
Denmark Participants 2010 After Gardasil Licensure
n=287 Participants
|
Denmark Participants 2011 After Gardasil Licensure
n=211 Participants
|
|---|---|---|---|---|---|---|
|
Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age
Overall CIN
|
179.5 Cases per 100,000 women
Interval 30.8 to 42.3
|
251.3 Cases per 100,000 women
Interval 32.5 to 43.6
|
172.6 Cases per 100,000 women
Interval 26.6 to 37.7
|
196.2 Cases per 100,000 women
Interval 30.7 to 41.8
|
140.8 Cases per 100,000 women
Interval 32.1 to 41.9
|
228.3 Cases per 100,000 women
Interval 29.8 to 40.9
|
|
Incidence of Cervical Intraepithelial Neoplasia Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age
CIN not related to HPV 16/18
|
65.9 Cases per 100,000 women
|
100.0 Cases per 100,000 women
|
57.5 Cases per 100,000 women
|
70.0 Cases per 100,000 women
|
52.0 Cases per 100,000 women
|
86.5 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)Population: The analysis population was participants with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=202 Participants
|
Denmark Participants 2007, After Gardasil Licensure
n=203 Participants
|
Denmark Participants 2008 After Gardasil Licensure
n=187 Participants
|
Denmark Participants 2009 After Gardasil Licensure
n=185 Participants
|
Denmark Participants 2010 After Gardasil Licensure
n=148 Participants
|
Denmark Participants 2011 After Gardasil Licensure
n=126 Participants
|
|---|---|---|---|---|---|---|
|
Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants of All Ages
Overall cervical cancer
|
13.8 Cases per 100,000 women
Interval 0.6 to 4.0
|
12.4 Cases per 100,000 women
Interval 0.0 to 1.8
|
11.7 Cases per 100,000 women
Interval 0.0 to 1.9
|
11.7 Cases per 100,000 women
Interval 0.0 to 1.8
|
8.4 Cases per 100,000 women
Interval 0.3 to 2.6
|
8.7 Cases per 100,000 women
Interval 0.2 to 2.9
|
|
Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants of All Ages
HPV 6/11/16/18-related cervical cancer
|
9.0 Cases per 100,000 women
|
9.0 Cases per 100,000 women
|
7.4 Cases per 100,000 women
|
7.7 Cases per 100,000 women
|
5.2 Cases per 100,000 women
|
6.3 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)Population: The analysis population was participants \<=26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=9 Participants
|
Denmark Participants 2007, After Gardasil Licensure
n=11 Participants
|
Denmark Participants 2008 After Gardasil Licensure
n=4 Participants
|
Denmark Participants 2009 After Gardasil Licensure
n=5 Participants
|
Denmark Participants 2010 After Gardasil Licensure
n=6 Participants
|
Denmark Participants 2011 After Gardasil Licensure
n=8 Participants
|
|---|---|---|---|---|---|---|
|
Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants <=26 Years of Age
Overall cervical cancer
|
2.6 Cases per 100,000 women
Interval 0.6 to 4.0
|
1.7 Cases per 100,000 women
Interval 0.0 to 1.8
|
0.9 Cases per 100,000 women
Interval 0.0 to 1.9
|
1.4 Cases per 100,000 women
Interval 0.0 to 1.8
|
0.8 Cases per 100,000 women
Interval 0.3 to 2.6
|
1.0 Cases per 100,000 women
Interval 0.2 to 2.9
|
|
Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants <=26 Years of Age
HPV 6/11/16/18-related cervical cancer
|
2.3 Cases per 100,000 women
|
1.7 Cases per 100,000 women
|
0.9 Cases per 100,000 women
|
1.4 Cases per 100,000 women
|
0.5 Cases per 100,000 women
|
0.75 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)Population: The analysis population was participants \>26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=193 Participants
|
Denmark Participants 2007, After Gardasil Licensure
n=192 Participants
|
Denmark Participants 2008 After Gardasil Licensure
n=183 Participants
|
Denmark Participants 2009 After Gardasil Licensure
n=180 Participants
|
Denmark Participants 2010 After Gardasil Licensure
n=142 Participants
|
Denmark Participants 2011 After Gardasil Licensure
n=118 Participants
|
|---|---|---|---|---|---|---|
|
Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants >26 Years of Age
Overall cervical cancer
|
19.3 Cases per 100,000 women
Interval 0.6 to 4.0
|
19.2 Cases per 100,000 women
Interval 0.0 to 1.8
|
18.6 Cases per 100,000 women
Interval 0.0 to 1.9
|
18.2 Cases per 100,000 women
Interval 0.0 to 1.8
|
13.3 Cases per 100,000 women
Interval 0.3 to 2.6
|
13.6 Cases per 100,000 women
Interval 0.2 to 2.9
|
|
Incidence of HPV 6/11/16/18-related Cervical Cancer in Participants >26 Years of Age
HPV 6/11/16/18-related cervical cancer
|
12.3 Cases per 100,000 women
|
13.6 Cases per 100,000 women
|
11.7 Cases per 100,000 women
|
11.8 Cases per 100,000 women
|
8.2 Cases per 100,000 women
|
9.8 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)Population: The analysis population was participants \<=26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=9 Participants
|
Denmark Participants 2007, After Gardasil Licensure
n=11 Participants
|
Denmark Participants 2008 After Gardasil Licensure
n=4 Participants
|
Denmark Participants 2009 After Gardasil Licensure
n=5 Participants
|
Denmark Participants 2010 After Gardasil Licensure
n=6 Participants
|
Denmark Participants 2011 After Gardasil Licensure
n=8 Participants
|
|---|---|---|---|---|---|---|
|
Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age
Overall cervical cancer
|
2.6 Cases per 100,000 women
Interval 30.8 to 42.3
|
1.7 Cases per 100,000 women
Interval 32.5 to 43.6
|
0.9 Cases per 100,000 women
Interval 26.6 to 37.7
|
1.4 Cases per 100,000 women
Interval 30.7 to 41.8
|
0.8 Cases per 100,000 women
Interval 32.1 to 41.9
|
1.0 Cases per 100,000 women
Interval 29.8 to 40.9
|
|
Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants <=26 Years of Age
Cervical cancer not related to HPV 16/18
|
0.3 Cases per 100,000 women
|
0.0 Cases per 100,000 women
|
0.0 Cases per 100,000 women
|
0.0 Cases per 100,000 women
|
0.1 Cases per 100,000 women
|
0.0 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)Population: The analysis population was participants \>26 years of age with newly-diagnosed cervical cancer and lesional tissue samples analyzed for HPV types
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=193 Participants
|
Denmark Participants 2007, After Gardasil Licensure
n=192 Participants
|
Denmark Participants 2008 After Gardasil Licensure
n=183 Participants
|
Denmark Participants 2009 After Gardasil Licensure
n=180 Participants
|
Denmark Participants 2010 After Gardasil Licensure
n=142 Participants
|
Denmark Participants 2011 After Gardasil Licensure
n=118 Participants
|
|---|---|---|---|---|---|---|
|
Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age
Overall cervical cancer
|
19.3 Cases per 100,000 women
Interval 0.6 to 4.0
|
19.2 Cases per 100,000 women
Interval 0.0 to 1.8
|
18.6 Cases per 100,000 women
Interval 0.0 to 1.9
|
18.2 Cases per 100,000 women
Interval 0.0 to 1.8
|
13.3 Cases per 100,000 women
Interval 0.3 to 2.6
|
13.6 Cases per 100,000 women
Interval 0.2 to 2.9
|
|
Incidence of Cervical Cancer Associated With High-risk HPV Types Other Than 16/18 in Participants >26 Years of Age
Cervical cancer not related to HPV 16/18
|
4.6 Cases per 100,000 women
|
3.6 Cases per 100,000 women
|
3.5 Cases per 100,000 women
|
3.4 Cases per 100,000 women
|
2.8 Cases per 100,000 women
|
2.0 Cases per 100,000 women
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)Population: Analysis of this endpoint was not planned nor were the data collected. Thus, the number of participants analyzed is zero.
The incidence of HPV-related histologically confirmed female genital diseases, including vulvar and vaginal cancer and their high-grade precursors was to be assessed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)Population: The analysis population was participants \<=26 years of age with liquid-based cytology samples analyzed for HPV types
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=831 Participants
|
Denmark Participants 2007, After Gardasil Licensure
n=1043 Participants
|
Denmark Participants 2008 After Gardasil Licensure
n=1055 Participants
|
Denmark Participants 2009 After Gardasil Licensure
n=1011 Participants
|
Denmark Participants 2010 After Gardasil Licensure
n=968 Participants
|
Denmark Participants 2011 After Gardasil Licensure
n=996 Participants
|
|---|---|---|---|---|---|---|
|
Prevalence of HPV 6/11/16/18 Infection in Participants <=26 Years of Age
|
20.3 Percentage of participants
Interval 17.6 to 23.2
|
14.2 Percentage of participants
Interval 12.1 to 16.5
|
26.7 Percentage of participants
Interval 24.1 to 29.5
|
22.6 Percentage of participants
Interval 20.0 to 25.3
|
19.0 Percentage of participants
Interval 16.6 to 21.6
|
13.4 Percentage of participants
Interval 11.3 to 15.6
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)Population: The analysis population was participants \>26 years of age with liquid-based cytology samples analyzed for HPV types
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=1486 Participants
|
Denmark Participants 2007, After Gardasil Licensure
n=1026 Participants
|
Denmark Participants 2008 After Gardasil Licensure
n=958 Participants
|
Denmark Participants 2009 After Gardasil Licensure
n=1217 Participants
|
Denmark Participants 2010 After Gardasil Licensure
n=1196 Participants
|
Denmark Participants 2011 After Gardasil Licensure
n=1006 Participants
|
|---|---|---|---|---|---|---|
|
Prevalence of HPV 6/11/16/18 Infection in Participants >26 Years of Age
|
6.3 Percentage of participants
Interval 5.1 to 7.6
|
4.7 Percentage of participants
Interval 3.5 to 6.2
|
5.5 Percentage of participants
Interval 4.2 to 7.2
|
6.2 Percentage of participants
Interval 4.9 to 7.7
|
5.6 Percentage of participants
Interval 4.4 to 7.1
|
7.7 Percentage of participants
Interval 6.1 to 9.5
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)Population: The analysis population was participants \<=26 years of age with liquid-based cytology samples analyzed for HPV types
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=831 Participants
|
Denmark Participants 2007, After Gardasil Licensure
n=1043 Participants
|
Denmark Participants 2008 After Gardasil Licensure
n=1055 Participants
|
Denmark Participants 2009 After Gardasil Licensure
n=1011 Participants
|
Denmark Participants 2010 After Gardasil Licensure
n=968 Participants
|
Denmark Participants 2011 After Gardasil Licensure
n=996 Participants
|
|---|---|---|---|---|---|---|
|
Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants <=26 Years of Age
|
25.6 Percentage of participants
Interval 22.7 to 28.7
|
22.8 Percentage of participants
Interval 20.3 to 25.5
|
27.5 Percentage of participants
Interval 24.8 to 30.3
|
23.5 Percentage of participants
Interval 21.0 to 26.3
|
21.2 Percentage of participants
Interval 18.6 to 23.9
|
24.6 Percentage of participants
Interval 22.0 to 27.4
|
PRIMARY outcome
Timeframe: Three years before Gardasil licensure (2004 to 2006) and two years after Gardasil licensure (2011 to 2012)Population: The analysis population was participants \>26 years of age with liquid-based cytology samples analyzed for HPV types
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=1486 Participants
|
Denmark Participants 2007, After Gardasil Licensure
n=1026 Participants
|
Denmark Participants 2008 After Gardasil Licensure
n=958 Participants
|
Denmark Participants 2009 After Gardasil Licensure
n=1217 Participants
|
Denmark Participants 2010 After Gardasil Licensure
n=1196 Participants
|
Denmark Participants 2011 After Gardasil Licensure
n=1006 Participants
|
|---|---|---|---|---|---|---|
|
Prevalence of HPV Infection for High-risk Types Other Than 16/18 for Participants >26 Years of Age
|
12.6 Percentage of participants
Interval 10.9 to 14.4
|
9.0 Percentage of participants
Interval 7.3 to 10.9
|
9.6 Percentage of participants
Interval 7.8 to 11.6
|
9.1 Percentage of participants
Interval 7.6 to 10.9
|
9.0 Percentage of participants
Interval 7.5 to 10.8
|
11.0 Percentage of participants
Interval 9.2 to 13.1
|
PRIMARY outcome
Timeframe: Up to 5 years after Gardasil licensure (2007 to 2011)Population: 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)
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.
Outcome measures
| Measure |
Denmark Participants 2004 to 2006 Before Gardasil Licensure
n=371 Participants
|
Denmark Participants 2007, After Gardasil Licensure
n=320891 Participants
|
Denmark Participants 2008 After Gardasil Licensure
n=23 Participants
|
Denmark Participants 2009 After Gardasil Licensure
n=306290 Participants
|
Denmark Participants 2010 After Gardasil Licensure
n=105 Participants
|
Denmark Participants 2011 After Gardasil Licensure
n=543738 Participants
|
|---|---|---|---|---|---|---|
|
Percentage of Live Born Babies With a Major Congenital Anomaly
|
5.9 Percentage of babies with a MCA
|
4.4 Percentage of babies with a MCA
|
4.3 Percentage of babies with a MCA
|
2.9 Percentage of babies with a MCA
|
2.9 Percentage of babies with a MCA
|
3.0 Percentage of babies with a MCA
|
SECONDARY outcome
Timeframe: Four years to 5 years after Gardasil licensure (2011 to 2012)Population: 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.
The incidence of CIN by Gardasil vaccination status was to be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four years to 5 years after Gardasil licensure (2011 to 2012)Population: 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.
The incidence of other cervical cancers by Gardasil vaccination status was to be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four years to 5 years after Gardasil licensure (2011 to 2012)Population: 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.
The incidence of other HPV-related genital diseases, including vulvar and vaginal cancers, by Gardasil vaccination status was to be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four years to 5 years after Gardasil licensure (2011 to 2012)Population: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Denmark Participants
Norway Participants
Sweden Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER