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Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older

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ClinicalTrials.gov Identifier: NCT00294047
Recruitment Status : Completed
First Posted : February 20, 2006
Results First Posted : March 27, 2012
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Interventions Biological: Cervarix
Biological: Placebo control
Enrollment 5752

Recruitment Details Some subjects completed the study at Months 36 and 48 as they did not want to participate to the extensions up to Month 84, but they were included in the safety analysis for these subsequent timepoints.
Pre-assignment Details Enrolment was stratified by (1) age, with the majority of subjects in age strata 26 – 35 years and 36 – 45 years (about 45% each) and about 10% in the age stratum 46+ years, and (2) previous HPV history (in each age stratum, the number of women with a history of HPV infection/treatment was limited to approximately 15%).
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Period Title: Month 48
Started 2881 2871
Participated up to Month 48 2305 2281
Completed 2456 2438
Not Completed 425 433
Reason Not Completed
Adverse Event             28             13
Protocol Violation             4             4
Withdrawal by Subject             111             115
Lost to Follow-up             272             287
Other             10             14
Period Title: Month 84
Started 2877 2870
Completed 1904 [1] 1881 [2]
Not Completed 973 989
Reason Not Completed
Adverse Event             4             2
Protocol Violation             1             1
Withdrawal by Subject             33             31
Lost to Follow-up             187             190
Absent Cervix             2             0
Work related reasons             4             2
Center closed, subject did not transfer             1             0
Family problems             2             2
Lack of time             3             1
Personal reason             2             4
Subject does not want male physician             1             0
Transport reimbursement delayed             0             1
Unable to reach study site             1             0
Under investigation locally             1             0
Visit missed             0             1
No consent for Month 84 Follow-up             731             754
[1]
The number of subjects who remained up to Month 48 in the Cervarix Group = 2146
[2]
The number of subjects who remained up to Month 48 in the Aluminium Hydroxide Group = 2116
Arm/Group Title Cervarix Group Aluminium Hydroxide Group Total
Hide Arm/Group Description Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. Total of all reporting groups
Overall Number of Baseline Participants 2881 2871 5752
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2881 participants 2871 participants 5752 participants
37.0  (7.24) 37.0  (7.32) 37.0  (7.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2881 participants 2871 participants 5752 participants
Female
2881
 100.0%
2871
 100.0%
5752
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
Hide Description

CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.

Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.

  • DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA)
  • Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus
Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2224 2190
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- and sero- subjects Number Analyzed 1898 participants 1854 participants
7
   0.4%
36
   1.9%
HPV-16, DNA- and sero- subjects Number Analyzed 1545 participants 1521 participants
5
   0.3%
27
   1.8%
HPV-18, DNA- and sero- subjects Number Analyzed 1597 participants 1571 participants
2
   0.1%
10
   0.6%
HPV-16/18, DNA- and sero+ subjects Number Analyzed 900 participants 864 participants
2
   0.2%
14
   1.6%
HPV-16, DNA- and sero+ subjects Number Analyzed 605 participants 594 participants
1
   0.2%
9
   1.5%
HPV-18, DNA- and sero+ subjects Number Analyzed 574 participants 550 participants
1
   0.2%
5
   0.9%
HPV-16/18, overall Number Analyzed 2224 participants 2190 participants
9
   0.4%
51
   2.3%
HPV-16, overall Number Analyzed 2167 participants 2131 participants
6
   0.3%
36
   1.7%
HPV-18, overall Number Analyzed 2203 participants 2165 participants
3
   0.1%
16
   0.7%
2.Primary Outcome
Title Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
Hide Description

CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.

  • DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0).
  • Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2224 2190
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- and sero- subjects Number Analyzed 1898 participants 1854 participants
7
   0.4%
36
   1.9%
HPV-16, DNA- and sero- subjects Number Analyzed 1545 participants 1521 participants
5
   0.3%
27
   1.8%
HPV-18, DNA- and sero- subjects Number Analyzed 1597 participants 1571 participants
2
   0.1%
10
   0.6%
HPV-16/18, DNA- and sero+ subjects Number Analyzed 900 participants 864 participants
2
   0.2%
12
   1.4%
HPV-16, DNA- and sero+ subjects Number Analyzed 605 participants 594 participants
1
   0.2%
8
   1.3%
HPV-18, DNA- and sero+ subjects Number Analyzed 574 participants 550 participants
1
   0.2%
4
   0.7%
HPV-16/18, overall Number Analyzed 2224 participants 2190 participants
9
   0.4%
49
   2.2%
HPV-16, overall Number Analyzed 2167 participants 2131 participants
6
   0.3%
35
   1.6%
HPV-18, overall Number Analyzed 2203 participants 2165 participants
3
   0.1%
15
   0.7%
3.Primary Outcome
Title Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
Hide Description CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus
Time Frame Up to Month 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2168 2147
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- and sero- subjects Number Analyzed 1852 participants 1818 participants
7
   0.4%
71
   3.9%
HPV-16, DNA- and sero- subjects Number Analyzed 1507 participants 1491 participants
5
   0.3%
53
   3.6%
HPV-18, DNA- and sero- subjects Number Analyzed 1565 participants 1541 participants
3
   0.2%
20
   1.3%
HPV-16/18, DNA- and sero+ subjects Number Analyzed 870 participants 849 participants
3
   0.3%
16
   1.9%
HPV-16, DNA- and sero+ subjects Number Analyzed 588 participants 584 participants
2
   0.3%
10
   1.7%
HPV-18, DNA- and sero+ subjects Number Analyzed 552 participants 540 participants
1
   0.2%
6
   1.1%
HPV-16/18, overall Number Analyzed 2168 participants 2147 participants
10
   0.5%
90
   4.2%
HPV-16, overall Number Analyzed 2112 participants 2091 participants
7
   0.3%
63
   3.0%
HPV-18, overall Number Analyzed 2149 participants 2123 participants
4
   0.2%
29
   1.4%
4.Primary Outcome
Title Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
Hide Description CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time Frame Up to Month 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2168 2147
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- and sero- subjects Number Analyzed 1852 participants 1818 participants
7
   0.4%
71
   3.9%
HPV-16, DNA- and sero- subjects Number Analyzed 1507 participants 1491 participants
5
   0.3%
53
   3.6%
HPV-18, DNA- and sero- subjects Number Analyzed 1565 participants 1541 participants
2
   0.1%
20
   1.3%
HPV-16/18, DNA- and sero+ subjects Number Analyzed 870 participants 849 participants
3
   0.3%
14
   1.6%
HPV-16, DNA- and sero+ subjects Number Analyzed 588 participants 584 participants
2
   0.3%
9
   1.5%
HPV-18, DNA- and sero+ subjects Number Analyzed 552 participants 540 participants
1
   0.2%
5
   0.9%
HPV-16/18, overall Number Analyzed 2168 participants 2147 participants
10
   0.5%
88
   4.1%
HPV-16, overall Number Analyzed 2112 participants 2091 participants
7
   0.3%
62
   3.0%
HPV-18, overall Number Analyzed 2149 participants 2123 participants
3
   0.1%
28
   1.3%
5.Secondary Outcome
Title Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Hide Description

Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.

Detection was done in:

  • DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0).
  • Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2178 2152
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- and sero- subjects Number Analyzed 1859 participants 1822 participants
6
   0.3%
34
   1.9%
HPV-16, DNA- and sero- subjects Number Analyzed 1518 participants 1495 participants
5
   0.3%
26
   1.7%
HPV-18, DNA- and sero- subjects Number Analyzed 1566 participants 1542 participants
1
   0.1%
8
   0.5%
HPV-16/18, DNA- and sero+ subjects Number Analyzed 880 participants 851 participants
2
   0.2%
11
   1.3%
HPV-16, DNA- and sero+ subjects Number Analyzed 591 participants 583 participants
1
   0.2%
8
   1.4%
HPV-18, DNA- and sero+ subjects Number Analyzed 562 participants 543 participants
1
   0.2%
3
   0.6%
HPV-16/18, overall Number Analyzed 2178 participants 2152 participants
8
   0.4%
45
   2.1%
HPV-16, overall Number Analyzed 2126 participants 2094 participants
6
   0.3%
34
   1.6%
HPV-18, overall Number Analyzed 2160 participants 2127 participants
2
   0.1%
11
   0.5%
6.Secondary Outcome
Title Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Hide Description

Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals).

  • DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0).
  • Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2146 2124
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- and sero- subjects Number Analyzed 1832 participants 1800 participants
2
   0.1%
18
   1.0%
HPV-16, DNA- and sero- subjects Number Analyzed 1499 participants 1476 participants
1
   0.1%
12
   0.8%
HPV-18, DNA- and sero- subjects Number Analyzed 1543 participants 1525 participants
1
   0.1%
6
   0.4%
HPV-16/18, DNA- and sero+ subjects Number Analyzed 864 participants 839 participants
0
   0.0%
3
   0.4%
HPV-16, DNA- and sero+ subjects Number Analyzed 579 participants 577 participants
0
   0.0%
2
   0.3%
HPV-18, DNA- and sero+ subjects Number Analyzed 553 participants 532 participants
0
   0.0%
1
   0.2%
HPV-16/18, overall Number Analyzed 2146 participants 2124 participants
2
   0.1%
21
   1.0%
HPV-16, overall Number Analyzed 2095 participants 2069 participants
1
   0.0%
14
   0.7%
HPV-18, overall Number Analyzed 2128 participants 2099 participants
1
   0.0%
7
   0.3%
7.Secondary Outcome
Title Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
Hide Description

Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.

Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus.

HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2179 2154
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 2126 participants 2094 participants
6
   0.3%
34
   1.6%
HPV-18 Number Analyzed 2160 participants 2127 participants
2
   0.1%
11
   0.5%
HPV-31 Number Analyzed 2126 participants 2132 participants
4
   0.2%
19
   0.9%
HPV-33 Number Analyzed 2158 participants 2136 participants
8
   0.4%
6
   0.3%
HPV-35 Number Analyzed 2165 participants 2144 participants
8
   0.4%
13
   0.6%
HPV-39 Number Analyzed 2150 participants 2119 participants
20
   0.9%
11
   0.5%
HPV-45 Number Analyzed 2160 participants 2130 participants
4
   0.2%
17
   0.8%
HPV-51 Number Analyzed 2125 participants 2113 participants
27
   1.3%
26
   1.2%
HPV-52 Number Analyzed 2113 participants 2101 participants
33
   1.6%
38
   1.8%
HPV-56 Number Analyzed 2154 participants 2123 participants
16
   0.7%
20
   0.9%
HPV-58 Number Analyzed 2152 participants 2135 participants
12
   0.6%
8
   0.4%
HPV-59 Number Analyzed 2158 participants 2126 participants
12
   0.6%
11
   0.5%
HPV-66 Number Analyzed 2141 participants 2122 participants
27
   1.3%
27
   1.3%
HPV-68 Number Analyzed 2138 participants 2128 participants
15
   0.7%
23
   1.1%
HPV-31/45 Number Analyzed 2175 participants 2152 participants
8
   0.4%
35
   1.6%
HPV-31/45/33/52/58 Number Analyzed 2179 participants 2154 participants
58
   2.7%
83
   3.9%
HPV-39/45/59/68 Number Analyzed 2179 participants 2154 participants
50
   2.3%
60
   2.8%
HPV-31/33/35/52/58 Number Analyzed 2179 participants 2154 participants
63
   2.9%
80
   3.7%
HPV-31/45/33/52/58/35/39/51/56/59 Number Analyzed 2179 participants 2154 participants
132
   6.1%
146
   6.8%
HPV-HRW Number Analyzed 2179 participants 2154 participants
163
   7.5%
185
   8.6%
HPV-HR Number Analyzed 2179 participants 2154 participants
170
   7.8%
217
  10.1%
8.Secondary Outcome
Title Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
Hide Description

Persistent HPV infection (12-month definition) = detection of the same HPV type(s) by PCR in cervical samples at available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals).

Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus.

HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68

Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2147 2126
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 2095 participants 2069 participants
1
   0.0%
14
   0.7%
HPV-18 Number Analyzed 2128 participants 2099 participants
1
   0.0%
7
   0.3%
HPV-31 Number Analyzed 2096 participants 2104 participants
2
   0.1%
10
   0.5%
HPV-33 Number Analyzed 2126 participants 2110 participants
5
   0.2%
5
   0.2%
HPV-35 Number Analyzed 2133 participants 2116 participants
3
   0.1%
8
   0.4%
HPV-39 Number Analyzed 2119 participants 2091 participants
12
   0.6%
5
   0.2%
HPV-45 Number Analyzed 2129 participants 2102 participants
4
   0.2%
8
   0.4%
HPV-51 Number Analyzed 2093 participants 2086 participants
11
   0.5%
14
   0.7%
HPV-52 Number Analyzed 2081 participants 2074 participants
21
   1.0%
23
   1.1%
HPV-56 Number Analyzed 2124 participants 2096 participants
4
   0.2%
8
   0.4%
HPV-58 Number Analyzed 2120 participants 2108 participants
8
   0.4%
7
   0.3%
HPV-59 Number Analyzed 2126 participants 2098 participants
4
   0.2%
3
   0.1%
HPV-66 Number Analyzed 2109 participants 2094 participants
10
   0.5%
8
   0.4%
HPV-68 Number Analyzed 2106 participants 2100 participants
7
   0.3%
13
   0.6%
HPV-31/45 Number Analyzed 2144 participants 2124 participants
6
   0.3%
17
   0.8%
HPV-31/45/33/52/58 Number Analyzed 2147 participants 2126 participants
39
   1.8%
49
   2.3%
HPV-39/45/59/68 Number Analyzed 2147 participants 2126 participants
27
   1.3%
29
   1.4%
HPV-31/33/35/52/58 Number Analyzed 2147 participants 2126 participants
38
   1.8%
51
   2.4%
HPV-31/45/33/52/58/35/39/51/56/59 Number Analyzed 2147 participants 2126 participants
70
   3.3%
84
   4.0%
HPV-HRW Number Analyzed 2147 participants 2126 participants
86
   4.0%
105
   4.9%
HPV-HR Number Analyzed 2147 participants 2126 participants
88
   4.1%
122
   5.7%
9.Secondary Outcome
Title Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Hide Description

CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.

Detection was done in:

  • DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).
  • Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.

Note: Results for seropositive status were not analysed.

Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2224 2190
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- and sero- subjects Number Analyzed 1898 participants 1854 participants
0
   0.0%
4
   0.2%
HPV-16, DNA- and sero- subjects Number Analyzed 1545 participants 1521 participants
0
   0.0%
3
   0.2%
HPV-18, DNA- and sero- subjects Number Analyzed 1597 participants 1571 participants
0
   0.0%
2
   0.1%
HPV-16/18, overall Number Analyzed 2224 participants 2190 participants
0
   0.0%
6
   0.3%
HPV-16, overall Number Analyzed 2167 participants 2131 participants
0
   0.0%
3
   0.1%
HPV-18, overall Number Analyzed 2203 participants 2165 participants
0
   0.0%
4
   0.2%
10.Secondary Outcome
Title Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Hide Description

CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.

Detection was done in:

  • DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).
  • Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2224 2190
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- and sero- subjects Number Analyzed 1898 participants 1854 participants
1
   0.1%
7
   0.4%
HPV-16, DNA- and sero- subjects Number Analyzed 1545 participants 1521 participants
0
   0.0%
5
   0.3%
HPV-18, DNA- and sero- subjects Number Analyzed 1597 participants 1571 participants
1
   0.1%
3
   0.2%
HPV-16/18, DNA- and sero+ subjects Number Analyzed 900 participants 864 participants
0
   0.0%
3
   0.3%
HPV-16, DNA- and sero+ subjects Number Analyzed 605 participants 594 participants
0
   0.0%
1
   0.2%
HPV-18, DNA- and sero+ subjects Number Analyzed 574 participants 550 participants
0
   0.0%
2
   0.4%
HPV-16/18, overall Number Analyzed 2224 participants 2190 participants
1
   0.0%
11
   0.5%
HPV-16, overall Number Analyzed 2167 participants 2131 participants
0
   0.0%
6
   0.3%
HPV-18, overall Number Analyzed 2203 participants 2165 participants
1
   0.0%
6
   0.3%
11.Secondary Outcome
Title Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Hide Description

CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.

Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.

Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2740 2737
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18
35
   1.3%
56
   2.0%
HPV-16
24
   0.9%
42
   1.5%
HPV-18
13
   0.5%
20
   0.7%
12.Secondary Outcome
Title Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status
Hide Description

CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.

Detection was done on all subjects irrespective of their baseline HPV DNA status.

Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2740 2737
Measure Type: Count of Participants
Unit of Measure: Participants
152
   5.5%
178
   6.5%
13.Secondary Outcome
Title Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
Hide Description

Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US).

Detection was done in:

  • DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).
  • Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.

Results for seropositive status were not analysed.

Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2224 2190
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- and sero- subjects Number Analyzed 1898 participants 1854 participants
2
   0.1%
31
   1.7%
HPV-16, DNA- and sero- subjects Number Analyzed 1545 participants 1521 participants
2
   0.1%
24
   1.6%
HPV-18, DNA- and sero- subjects Number Analyzed 1597 participants 1571 participants
0
   0.0%
8
   0.5%
HPV-16/18, overall Number Analyzed 2224 participants 2190 participants
5
   0.2%
38
   1.7%
HPV-16 Number Analyzed 2167 participants 2131 participants
4
   0.2%
27
   1.3%
HPV-18 Number Analyzed 2203 participants 2165 participants
1
   0.0%
12
   0.6%
14.Secondary Outcome
Title Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
Hide Description

Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus.

HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68

Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2225 2192
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 2167 participants 2131 participants
4
   0.2%
27
   1.3%
HPV-18 Number Analyzed 2203 participants 2165 participants
1
   0.0%
12
   0.6%
HPV-31 Number Analyzed 2172 participants 2170 participants
4
   0.2%
12
   0.6%
HPV-33 Number Analyzed 2204 participants 2173 participants
4
   0.2%
4
   0.2%
HPV-35 Number Analyzed 2211 participants 2181 participants
4
   0.2%
10
   0.5%
HPV-39 Number Analyzed 2196 participants 2156 participants
10
   0.5%
11
   0.5%
HPV-45 Number Analyzed 2206 participants 2168 participants
3
   0.1%
17
   0.8%
HPV-51 Number Analyzed 2171 participants 2149 participants
21
   1.0%
18
   0.8%
HPV-52 Number Analyzed 2158 participants 2139 participants
19
   0.9%
19
   0.9%
HPV-56 Number Analyzed 2200 participants 2158 participants
9
   0.4%
19
   0.9%
HPV-58 Number Analyzed 2198 participants 2172 participants
12
   0.5%
6
   0.3%
HPV-59 Number Analyzed 2202 participants 2164 participants
4
   0.2%
15
   0.7%
HPV-66 Number Analyzed 2187 participants 2160 participants
13
   0.6%
26
   1.2%
HPV-68 Number Analyzed 2184 participants 2164 participants
8
   0.4%
8
   0.4%
HPV-31/45 Number Analyzed 2221 participants 2190 participants
7
   0.3%
28
   1.3%
HPV-31/45/33/52/58 Number Analyzed 2225 participants 2192 participants
40
   1.8%
54
   2.5%
HPV-39/45/59/68 Number Analyzed 2225 participants 2192 participants
24
   1.1%
48
   2.2%
HPV-31/33/35/52/58 Number Analyzed 2225 participants 2192 participants
41
   1.8%
49
   2.2%
HPV-31/45/33/52/58/35/39/51/56/59 Number Analyzed 2225 participants 2192 participants
79
   3.6%
107
   4.9%
HPV-HRW Number Analyzed 2225 participants 2192 participants
94
   4.2%
126
   5.7%
HPV-HR Number Analyzed 2225 participants 2192 participants
96
   4.3%
148
   6.8%
15.Secondary Outcome
Title Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy
Hide Description Detection was done on all subjects irrespective of their baseline HPV DNA status.
Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2740 2737
Measure Type: Count of Participants
Unit of Measure: Participants
76
   2.8%
84
   3.1%
16.Secondary Outcome
Title Number of Subjects With First Colposcopy
Hide Description Detection was done on all subjects irrespective of their baseline HPV DNA status.
Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2741 2738
Measure Type: Count of Participants
Unit of Measure: Participants
392
  14.3%
422
  15.4%
17.Secondary Outcome
Title Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection
Hide Description

Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.

CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.

Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.

Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2772 2779
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18
90
   3.2%
158
   5.7%
HPV-16
64
   2.3%
118
   4.2%
HPV-18
30
   1.1%
52
   1.9%
18.Secondary Outcome
Title Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
Hide Description

Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.

Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.

The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types)

Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2772 2779
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18
89
   3.2%
155
   5.6%
HPV-16
63
   2.3%
117
   4.2%
HPV-18
29
   1.0%
49
   1.8%
19.Secondary Outcome
Title Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Hide Description

Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination.

Immuno subset=subjects from selected sites N≥1000, at least 250 per region

Time Frame At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 406 374
Measure Type: Count of Participants
Unit of Measure: Participants
Sero- before vaccination Number Analyzed 406 participants 374 participants
0
   0.0%
0
   0.0%
Sero- at Month 7 Number Analyzed 406 participants 371 participants
406
 100.0%
13
   3.5%
Sero- at Month 12 Number Analyzed 384 participants 349 participants
384
 100.0%
28
   8.0%
Sero- at Month 18 Number Analyzed 377 participants 340 participants
377
 100.0%
9
   2.6%
Sero- at Month 24 Number Analyzed 392 participants 350 participants
392
 100.0%
11
   3.1%
Sero- at Month 36 Number Analyzed 361 participants 320 participants
361
 100.0%
23
   7.2%
Sero- at Month 48 Number Analyzed 345 participants 316 participants
345
 100.0%
31
   9.8%
Sero- at Month 60 Number Analyzed 275 participants 251 participants
275
 100.0%
11
   4.4%
Sero- at Month 72 Number Analyzed 277 participants 260 participants
276
  99.6%
5
   1.9%
Sero- at Month 84 Number Analyzed 275 participants 255 participants
273
  99.3%
2
   0.8%
Sero+ before vaccination Number Analyzed 170 participants 179 participants
170
 100.0%
179
 100.0%
Sero+ at Month 7 Number Analyzed 170 participants 179 participants
170
 100.0%
166
  92.7%
Sero+ at Month 12 Number Analyzed 154 participants 158 participants
154
 100.0%
151
  95.6%
Sero+ at Month 24 Number Analyzed 158 participants 165 participants
158
 100.0%
144
  87.3%
Sero+ at Month 18 Number Analyzed 147 participants 154 participants
147
 100.0%
136
  88.3%
Sero+ at Month 36 Number Analyzed 137 participants 146 participants
137
 100.0%
131
  89.7%
Sero+ at Month 48 Number Analyzed 132 participants 145 participants
132
 100.0%
135
  93.1%
Sero+ at Month 60 Number Analyzed 99 participants 95 participants
99
 100.0%
79
  83.2%
Sero+ at Month 72 Number Analyzed 99 participants 102 participants
99
 100.0%
57
  55.9%
Sero+ at Month 84 Number Analyzed 95 participants 101 participants
95
 100.0%
51
  50.5%
20.Secondary Outcome
Title Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Hide Description

Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination.

Immuno subset=subjects from selected sites N≥1000, at least 250 per region

Time Frame At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 405 379
Measure Type: Count of Participants
Unit of Measure: Participants
Sero- before vaccination Number Analyzed 405 participants 379 participants
0
   0.0%
0
   0.0%
Sero- at Month 7 Number Analyzed 405 participants 374 participants
405
 100.0%
12
   3.2%
Sero- at Month 12 Number Analyzed 376 participants 352 participants
375
  99.7%
16
   4.5%
Sero- at Month 18 Number Analyzed 366 participants 347 participants
366
 100.0%
12
   3.5%
Sero- at Month 24 Number Analyzed 389 participants 358 participants
387
  99.5%
14
   3.9%
Sero- at Month 36 Number Analyzed 348 participants 328 participants
346
  99.4%
14
   4.3%
Sero- at Month 48 Number Analyzed 338 participants 320 participants
336
  99.4%
16
   5.0%
Sero- at Month 60 Number Analyzed 268 participants 246 participants
266
  99.3%
11
   4.5%
Sero- at Month 72 Number Analyzed 269 participants 254 participants
261
  97.0%
3
   1.2%
Sero- at month 84 Number Analyzed 268 participants 248 participants
257
  95.9%
3
   1.2%
Sero+ before vaccination Number Analyzed 163 participants 164 participants
163
 100.0%
164
 100.0%
Sero+ at Month 7 Number Analyzed 163 participants 161 participants
163
 100.0%
146
  90.7%
Sero+ at Month 12 Number Analyzed 154 participants 144 participants
154
 100.0%
133
  92.4%
Sero+ at Month 18 Number Analyzed 149 participants 141 participants
149
 100.0%
118
  83.7%
Sero+ at Month 24 Number Analyzed 153 participants 150 participants
153
 100.0%
114
  76.0%
Sero+ at Month 36 Number Analyzed 142 participants 131 participants
142
 100.0%
92
  70.2%
Sero+ at Month 48 Number Analyzed 133 participants 131 participants
133
 100.0%
94
  71.8%
Sero+ at Month 60 Number Analyzed 101 participants 91 participants
101
 100.0%
58
  63.7%
Sero+ at Month 72 Number Analyzed 103 participants 99 participants
103
 100.0%
32
  32.3%
Sero+ at Month 84 Number Analyzed 98 participants 98 participants
98
 100.0%
32
  32.7%
21.Secondary Outcome
Title Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
Hide Description

GMCs were expressed in ELISA units per milliliter (EL.U/mL).

Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination.

Immuno subset=subjects from selected sites (N≥1000, at least 250 per region)

Time Frame At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 406 374
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Sero-before vaccination Number Analyzed 406 participants 374 participants
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Sero- at Month 7 Number Analyzed 406 participants 371 participants
5412.9
(4934.3 to 5938.0)
4.3
(4.1 to 4.4)
Sero- at Month 12 Number Analyzed 384 participants 349 participants
1542.5
(1393.2 to 1707.8)
4.4
(4.2 to 4.5)
Sero- at Month 18 Number Analyzed 377 participants 340 participants
992.6
(893.9 to 1102.2)
4.1
(4.0 to 4.2)
Sero- at Month 24 Number Analyzed 392 participants 350 participants
827.8
(745.2 to 919.5)
4.2
(4.1 to 4.4)
Sero- at Month 36 Number Analyzed 361 participants 320 participants
612.9
(550.1 to 682.8)
4.5
(4.2 to 4.7)
Sero- at Month 48 Number Analyzed 345 participants 316 participants
546.2
(490.4 to 608.2)
4.6
(4.4 to 4.9)
Sero- at Month 60 Number Analyzed 275 participants 251 participants
447.1
(394.3 to 507.0)
4.3
(4.1 to 4.5)
Sero- at Month 72 Number Analyzed 277 participants 260 participants
412.8
(364.0 to 468.1)
9.8
(9.5 to 10.0)
Sero- at Month 84 Number Analyzed 275 participants 255 participants
381.0
(334.7 to 433.8)
9.6
(9.4 to 9.9)
Sero+ before vaccination Number Analyzed 170 participants 179 participants
39.3
(33.6 to 45.9)
38.6
(33.2 to 44.9)
Sero+ at Month 7 Number Analyzed 170 participants 179 participants
5845.5
(5113.8 to 6682.0)
33.4
(28.2 to 39.5)
Sero+ at month 12 Number Analyzed 154 participants 158 participants
2705.8
(2313.2 to 3165.1)
38.0
(32.0 to 45.3)
Sero+ at Month 18 Number Analyzed 147 participants 154 participants
2104.7
(1780.5 to 2487.8)
30.5
(25.2 to 36.9)
Sero+ at Month 24 Number Analyzed 158 participants 165 participants
1883.5
(1599.4 to 2218.1)
29.6
(24.5 to 35.7)
Sero+ at month 36 Number Analyzed 137 participants 146 participants
1363.8
(1138.2 to 1634.2)
30.6
(25.3 to 37.0)
Sero+ at Month 48 Number Analyzed 132 participants 145 participants
1261.2
(1048.4 to 1517.1)
34.3
(28.8 to 40.8)
Sero+ at Month 60 Number Analyzed 99 participants 95 participants
943.0
(749.2 to 1187.0)
24.7
(19.2 to 31.7)
Sero+ at Month 72 Number Analyzed 99 participants 102 participants
1053.7
(841.0 to 1320.3)
25.6
(20.7 to 31.5)
Sero+ at Month 84 Number Analyzed 95 participants 101 participants
954.3
(755.3 to 1205.8)
23.9
(19.3 to 29.5)
[1]
Not calculable as no subject had HPV-16 antibody concentration equal to or above the assay cut-off value.
22.Secondary Outcome
Title Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
Hide Description

GMCs were expressed in ELISA units per milliliter (EL.U/mL).

Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination.

Immuno subset=subjects from selected sites (N≥1000, at least 250 per region)

Time Frame At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 405 379
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Sero- before vaccination Number Analyzed 405 participants 379 participants
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Sero- at Month 7 Number Analyzed 405 participants 374 participants
2567.7
(2339.5 to 2818.2)
3.7
(3.6 to 3.9)
Sero- at Month 12 Number Analyzed 376 participants 352 participants
645.3
(576.6 to 722.1)
3.7
(3.6 to 3.9)
Sero- at Month 18 Number Analyzed 366 participants 347 participants
402.6
(359.7 to 450.6)
3.7
(3.6 to 3.8)
Sero- at Month 24 Number Analyzed 389 participants 358 participants
321.7
(286.9 to 360.7)
3.7
(3.6 to 3.9)
Sero- at Month 36 Number Analyzed 348 participants 328 participants
245.9
(218.5 to 276.8)
3.7
(3.6 to 3.8)
Sero- at Month 48 Number Analyzed 338 participants 320 participants
228.5
(201.9 to 258.7)
3.7
(3.6 to 3.8)
Sero- at Month 60 Number Analyzed 268 participants 246 participants
174.3
(151.2 to 200.8)
3.8
(3.6 to 4.0)
Sero- at Month 72 Number Analyzed 269 participants 254 participants
177.7
(154.1 to 204.8)
9.2
(9.0 to 9.5)
Sero- at Month 84 Number Analyzed 268 participants 248 participants
166.2
(143.4 to 192.7)
9.1
(9.0 to 9.3)
Sero+ before vaccination Number Analyzed 163 participants 164 participants
23.0
(19.9 to 26.7)
24.2
(20.6 to 28.4)
Sero+ at Month 7 Number Analyzed 163 participants 161 participants
2933.9
(2557.1 to 3366.3)
21.9
(18.1 to 26.5)
Sero+ at Month 12 Number Analyzed 154 participants 144 participants
936.2
(796.4 to 1100.4)
23.6
(19.4 to 28.7)
Sero+ at Month 18 Number Analyzed 149 participants 141 participants
661.3
(560.9 to 779.7)
19.5
(15.7 to 24.2)
Sero+ at Month 24 Number Analyzed 153 participants 150 participants
573.6
(487.7 to 674.6)
16.6
(13.5 to 20.5)
Sero+ at Month 36 Number Analyzed 142 participants 131 participants
423.1
(357.9 to 500.1)
16.4
(12.9 to 20.7)
Sero+ at Month 48 Number Analyzed 133 participants 131 participants
392.3
(328.9 to 468.0)
15.9
(12.7 to 19.9)
Sero+ at Month 60 Number Analyzed 101 participants 91 participants
306.0
(245.7 to 380.9)
12.9
(9.8 to 16.9)
Sero+ at Month 72 Number Analyzed 103 participants 99 participants
324.8
(264.3 to 399.1)
16.2
(13.3 to 19.6)
Sero+ at Month 84 Number Analyzed 98 participants 98 participants
302.2
(243.4 to 375.2)
16.5
(13.4 to 20.4)
[1]
Not calculable as no subject had HPV-18 antibody concentration equal to or above the assay cut-off value.
23.Secondary Outcome
Title Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
Hide Description Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16/18 assay cut-off value was defined as greater than or equal to 40 Estimated dose 50% (ED50). Sero- subjects are subjects who had an antibody concentration below 40 ED50 prior to vaccination. Sero+ subjects are subjects who had an antibody concentration equal to or above 50 ED50 prior to vaccination. ED50 = the estimated serum dilution reducing the signal generated by viral infection by 50%
Time Frame Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 38 37
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 sero- [pre-vaccination] Number Analyzed 37 participants 37 participants
0
   0.0%
0
   0.0%
HPV-16 sero- [at Month 7] Number Analyzed 37 participants 37 participants
37
 100.0%
1
   2.7%
HPV-16 sero- [at Month 12] Number Analyzed 37 participants 37 participants
37
 100.0%
0
   0.0%
HPV-16 sero- [at Month 18] Number Analyzed 36 participants 37 participants
36
 100.0%
0
   0.0%
HPV-16 sero- [at Month 24] Number Analyzed 35 participants 37 participants
35
 100.0%
2
   5.4%
HPV-16 sero- [at Month 48] Number Analyzed 27 participants 33 participants
27
 100.0%
1
   3.0%
HPV-16 sero- [at Month 84] Number Analyzed 20 participants 25 participants
19
  95.0%
1
   4.0%
HPV-16 sero+ [pre-vaccination] Number Analyzed 4 participants 1 participants
4
 100.0%
1
 100.0%
HPV-16 sero+ [at Month 7] Number Analyzed 4 participants 1 participants
4
 100.0%
1
 100.0%
HPV-16 sero+ [at Month 12] Number Analyzed 4 participants 1 participants
4
 100.0%
1
 100.0%
HPV-16 sero+ [at Month 18] Number Analyzed 4 participants 1 participants
4
 100.0%
1
 100.0%
HPV-16 sero+ [at Month 24] Number Analyzed 4 participants 1 participants
4
 100.0%
0
   0.0%
HPV-16 sero+ [at Month 48] Number Analyzed 3 participants 1 participants
3
 100.0%
0
   0.0%
HPV-16 sero+ [at Month 84] Number Analyzed 3 participants 1 participants
3
 100.0%
1
 100.0%
HPV-18 sero- [pre-vaccination] Number Analyzed 38 participants 35 participants
0
   0.0%
0
   0.0%
HPV-18 sero- [at Month 7] Number Analyzed 38 participants 35 participants
38
 100.0%
0
   0.0%
HPV-18 sero- [at Month 12] Number Analyzed 38 participants 35 participants
38
 100.0%
0
   0.0%
HPV-18 sero- [at Month 18] Number Analyzed 37 participants 35 participants
37
 100.0%
0
   0.0%
HPV-18 sero- [at Month 24] Number Analyzed 36 participants 35 participants
36
 100.0%
1
   2.9%
HPV-18 sero- [at Month 48] Number Analyzed 29 participants 32 participants
29
 100.0%
0
   0.0%
HPV-18 sero- [at Month 84] Number Analyzed 22 participants 25 participants
22
 100.0%
0
   0.0%
HPV-18 sero+ [pre-vaccination] Number Analyzed 3 participants 3 participants
3
 100.0%
3
 100.0%
HPV-18 sero+ [at Month 7] Number Analyzed 3 participants 3 participants
3
 100.0%
2
  66.7%
HPV-18 sero+ [at Month 12] Number Analyzed 3 participants 3 participants
3
 100.0%
2
  66.7%
HPV-18 sero+ [at Month 18] Number Analyzed 3 participants 3 participants
3
 100.0%
2
  66.7%
HPV-18 sero+ [at Month 24] Number Analyzed 3 participants 3 participants
3
 100.0%
2
  66.7%
HPV-18 sero+ [at Month 48] Number Analyzed 1 participants 2 participants
1
 100.0%
1
  50.0%
HPV-18 sero+ [at Month 84] Number Analyzed 1 participants 1 participants
1
 100.0%
1
 100.0%
24.Secondary Outcome
Title Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
Hide Description

Titers are expressed as geometric mean antibody titers (GMTs).

Seronegative (Sero-) subjects are subjects who had an antibody titer below 40 ED50 prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody titer equal to or above 40 ED50 prior to vaccination.

ED50 = Estimated dose 50%, the estimated serum dilution reducing the signal generated by viral infection by 50%

Time Frame Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 38 37
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
HPV-16 sero- [pre-vaccination] Number Analyzed 38 participants 37 participants
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
HPV-16 sero- [at Month 7] Number Analyzed 37 participants 37 participants
11663.5
(7507.2 to 18120.8)
20.8
(19.2 to 22.4)
HPV-16 sero- [at Month 12] Number Analyzed 37 participants 37 participants
5597.7
(3688.3 to 8495.6)
NA [1] 
(NA to NA)
HPV-16 sero- [at Month 18] Number Analyzed 36 participants 37 participants
2175.2
(1390.8 to 3401.9)
NA [1] 
(NA to NA)
HPV-16 sero- [at Month 24] Number Analyzed 35 participants 37 participants
1941.7
(1193.0 to 3160.4)
22.3
(18.6 to 26.6)
HPV-16 sero- [at Month 48] Number Analyzed 27 participants 33 participants
828.9
(488.4 to 1406.7)
21.4
(18.7 to 24.5)
HPV-16 sero- [at Month 84] Number Analyzed 20 participants 37 participants
1213.4
(1213.4 to 2779.1)
NA [1] 
(NA to NA)
HPV-16 sero+ [pre-vaccination] Number Analyzed 4 participants 37 participants
139.3
(32.7 to 594.2)
45.0 [2] 
(NA to NA)
HPV-16 sero+ [at Month 7] Number Analyzed 4 participants 37 participants
20283.2
(2428.3 to 169422.0)
107.0 [2] 
(NA to NA)
HPV-16 sero+ [at Month 12] Number Analyzed 4 participants 37 participants
19484.3
(7049.3 to 53854.2)
99.0 [2] 
(NA to NA)
HPV-16 sero+ [at Month 18] Number Analyzed 4 participants 37 participants
4393.3
(798.4 to 24175.0)
93.0 [2] 
(NA to NA)
HPV-16 sero+ [at Month 24] Number Analyzed 4 participants 37 participants
9459.1
(2168.4 to 41263.7)
NA [1] 
(NA to NA)
HPV-16 sero+ [at Month 48] Number Analyzed 3 participants 37 participants
4187.2
(676.4 to 25921.6)
NA [1] 
(NA to NA)
HPV-16 sero+ [at Month 84] Number Analyzed 3 participants 37 participants
5837.0
(5837.0 to 35354.6)
NA [1] 
(NA to NA)
HPV-18 sero- [pre-vaccination] Number Analyzed 38 participants 37 participants
NA [3] 
(NA to NA)
NA [3] 
(NA to NA)
HPV-18 sero- [at Month 7] Number Analyzed 38 participants 37 participants
7959.6
(4648.0 to 13630.7)
NA [3] 
(NA to NA)
HPV-18 sero- [at Month 12] Number Analyzed 38 participants 37 participants
1979.9
(1201.6 to 3262.5)
NA [3] 
(NA to NA)
HPV-18 sero- [at Month 18] Number Analyzed 37 participants 37 participants
1334.6
(793.3 to 2245.3)
NA [3] 
(NA to NA)
HPV-18 sero- [at Month 24] Number Analyzed 36 participants 35 participants
826.6
(493.6 to 1384.1)
21.4
(18.7 to 24.5)
HPV-18 sero- [at Month 48] Number Analyzed 29 participants 37 participants
386.1
(203.9 to 731.1)
NA [3] 
(NA to NA)
HPV-18 sero- [at Month 84] Number Analyzed 22 participants 37 participants
491.2
(232.9 to 1036.0)
NA [3] 
(NA to NA)
HPV-18 sero+ [pre-vaccination] Number Analyzed 3 participants 3 participants
84.7
(9.2 to 782.4)
115.5
(21.5 to 621.0)
HPV-18 sero+ [at Month 7] Number Analyzed 3 participants 3 participants
3014.5
(446.3 to 20361.5)
163.4
(0.8 to 31959.2)
HPV-18 sero+ [at Month 12] Number Analyzed 3 participants 3 participants
3377.8
(2563.9 to 4450.1)
167.3
(0.8 to 35164.4)
HPV-18 sero+ [at Month 18] Number Analyzed 3 participants 3 participants
3125.8
(595.8 to 16398.4)
254.9
(0.4 to 172814.0)
HPV-18 sero+ [at Month 24] Number Analyzed 3 participants 3 participants
2493.0
(261.2 to 23793.7)
154.9
(0.4 to 53341.9)
HPV-18 sero+ [at Month 48] Number Analyzed 38 participants 2 participants
545.0 [2] 
(NA to NA)
86.0
(0.0 to 9662500000)
HPV-18 sero+ [at Month 84] Number Analyzed 38 participants 37 participants
NA [2] 
(NA to NA)
968.0 [2] 
(NA to NA)
[1]
Not calculable as no subject had HPV-16 antibody titer equal to or above the assay cut-off value.
[2]
Data were not calculable because of too few subjects.
[3]
Not calculable as no subject had HPV-18 antibody titer equal to or above the assay cut-off value.
25.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Hide Description Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).
Time Frame Within 7 days (Days 0-6) after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheets completed.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2830 2831
Measure Type: Count of Participants
Unit of Measure: Participants
Any pain
2411
  85.2%
1862
  65.8%
Grade 3 pain
303
  10.7%
73
   2.6%
Any redness
1058
  37.4%
530
  18.7%
Grade 3 redness
44
   1.6%
5
   0.2%
Any swelling
1080
  38.2%
428
  15.1%
Grade 3 swelling
97
   3.4%
11
   0.4%
26.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Hide Description Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = axillary temperature above 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature above 39.0°C.
Time Frame Within 7 days (Days 0-6) after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheets completed.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2832 2832
Measure Type: Count of Participants
Unit of Measure: Participants
Any arthralgia
580
  20.5%
439
  15.5%
Grade3 arthralgia
30
   1.1%
24
   0.8%
Related arthralgia
323
  11.4%
225
   7.9%
Any fatigue
1116
  39.4%
916
  32.3%
Grade 3 fatigue
78
   2.8%
53
   1.9%
Related fatigue
678
  23.9%
545
  19.2%
Any fever
308
  10.9%
248
   8.8%
Grade 3 fever
17
   0.6%
8
   0.3%
Related fever
181
   6.4%
159
   5.6%
Any gastrointestinal
664
  23.4%
592
  20.9%
Grade 3 gastrointestinal
60
   2.1%
54
   1.9%
Related gastrointestinal
335
  11.8%
312
  11.0%
Any headache
1165
  41.1%
1074
  37.9%
Grade 3 headache
76
   2.7%
72
   2.5%
Related headache
666
  23.5%
598
  21.1%
Any myalgia
878
  31.0%
622
  22.0%
Grade 3 myalgia
46
   1.6%
32
   1.1%
Related myalgia
541
  19.1%
391
  13.8%
Any rash
185
   6.5%
124
   4.4%
Grade 3 rash
1
   0.0%
7
   0.2%
Related rash
88
   3.1%
61
   2.2%
Any urticaria
258
   9.1%
201
   7.1%
Grade 3 urticaria
21
   0.7%
18
   0.6%
Related urticaria
84
   3.0%
79
   2.8%
27.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Hide Description

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 unsolicited AE = an event that prevented normal activity.

A related AE = event assessed by the investigator as causally related to the study vaccination.

Time Frame Within 30 days (Days 0 – 29) post-vaccination period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2877 2870
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
1153
  40.1%
1164
  40.6%
Grade 3 AEs
208
   7.2%
184
   6.4%
Related AEs
246
   8.6%
191
   6.7%
28.Secondary Outcome
Title Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Hide Description SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. A related SAE was defined as an event assessed by the investigator as causally related to the study vaccination.
Time Frame Up to Month 48 and up to Month 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2877 2870
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAEs, M48
286
   9.9%
266
   9.3%
Related SAEs, M48
5
   0.2%
8
   0.3%
Any SAEs, M84
291
  10.1%
269
   9.4%
Related SAEs, M84
5
   0.2%
8
   0.3%
29.Secondary Outcome
Title Number of Subjects Reporting Related or Fatal Serious Adverse Event.
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame Up to Month 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2877 2870
Measure Type: Count of Participants
Unit of Measure: Participants
Fatal AEs
13
   0.5%
5
   0.2%
Related SAEs
5
   0.2%
8
   0.3%
30.Secondary Outcome
Title Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study.
Hide Description

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Time Frame Up to Month 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2877 2870
Measure Type: Count of Participants
Unit of Measure: Participants
28
   1.0%
14
   0.5%
31.Secondary Outcome
Title Number of Subjects Reporting New Onset of Chronic Disease (NOCDs).
Hide Description NOCDs include autoimmune disorders, asthma and type I diabetes.
Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2877 2870
Measure Type: Count of Participants
Unit of Measure: Participants
143
   5.0%
165
   5.7%
32.Secondary Outcome
Title Number of Subjects Reporting New Onset of Autoimmune Disease (NOADs).
Hide Description [Not Specified]
Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2877 2870
Measure Type: Count of Participants
Unit of Measure: Participants
24
   0.8%
24
   0.8%
33.Secondary Outcome
Title Number of Subjects Reporting Medically Significant Conditions (MAEs).
Hide Description Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2877 2870
Measure Type: Count of Participants
Unit of Measure: Participants
1170
  40.7%
1140
  39.7%
34.Secondary Outcome
Title Number of Subjects With Pregnancies and Their Outcomes.
Hide Description Pregnancy outcomes are live infant, premature live infant, elective termination, ectopic pregnancy, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).
Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 359 357
Measure Type: Count of Participants
Unit of Measure: Participants
Live infant No ACA, M48
259
  72.1%
249
  69.7%
Live infant CA, M48
4
   1.1%
7
   2.0%
Elective termination No ACA, M48
19
   5.3%
24
   6.7%
Elective termination CA, M48
1
   0.3%
0
   0.0%
Ectopic pregnancy, M48
5
   1.4%
6
   1.7%
Spontaneous abortion No ACA, M48
69
  19.2%
66
  18.5%
Spontaneous abortion CA, M48
0
   0.0%
1
   0.3%
Stillbirth No ACA, M48
0
   0.0%
2
   0.6%
Lost to follow-up, M48
2
   0.6%
2
   0.6%
35.Secondary Outcome
Title Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA)
Hide Description

CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer.

Detection was done on subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.

TAA: Type assignment algorithm. The lesion was assigned to an HPV type found in the lesion if

  1. the same HPV type was found in at least one of the two (closest) preceding cytology samples, or
  2. none of the HPV types found in the lesion were found in any of the two preceding cytology samples (isolate HPV types)
Time Frame Up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2224 2190
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18 DNA- Number Analyzed 2224 participants 2190 participants
1
   0.0%
9
   0.4%
HPV-16 DNA- Number Analyzed 2167 participants 2131 participants
0
   0.0%
5
   0.2%
HPV-18 DNA- Number Analyzed 2203 participants 2165 participants
1
   0.0%
5
   0.2%
36.Secondary Outcome
Title Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Hide Description Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in: - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time Frame Up to Month 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2124 2109
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- and sero- subjects Number Analyzed 1815 participants 1786 participants
6
   0.3%
67
   3.8%
HPV-16, DNA- and sero- subjects Number Analyzed 1482 participants 1466 participants
5
   0.3%
51
   3.5%
HPV-18, DNA- and sero- subjects Number Analyzed 1535 participants 1511 participants
1
   0.1%
17
   1.1%
HPV-16/18, DNA- and sero+ subjects Number Analyzed 851 participants 837 participants
3
   0.4%
13
   1.6%
HPV-16, DNA- and sero+ subjects Number Analyzed 574 participants 573 participants
2
   0.3%
9
   1.6%
HPV-18, DNA- and sero+ subjects Number Analyzed 541 participants 534 participants
1
   0.2%
4
   0.7%
HPV-16/18, overall Number Analyzed 2124 participants 2109 participants
9
   0.4%
82
   3.9%
HPV-16, overall Number Analyzed 2073 participants 2055 participants
7
   0.3%
60
   2.9%
HPV-18, overall Number Analyzed 2108 participants 2085 participants
2
   0.1%
23
   1.1%
37.Secondary Outcome
Title Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Hide Description Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time Frame Up to Month 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2093 2081
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- and sero- subjects Number Analyzed 1789 participants 1764 participants
2
   0.1%
37
   2.1%
HPV-16, DNA- and sero- subjects Number Analyzed 1464 participants 1447 participants
1
   0.1%
27
   1.9%
HPV-18, DNA- and sero- subjects Number Analyzed 1513 participants 1494 participants
1
   0.1%
10
   0.7%
HPV-16/18, DNA- and sero+ subjects Number Analyzed 835 participants 825 participants
0
   0.0%
5
   0.6%
HPV-16, DNA- and sero+ subjects Number Analyzed 562 participants 567 participants
0
   0.0%
3
   0.5%
HPV-18, DNA- and sero+ subjects Number Analyzed 532 participants 523 participants
0
   0.0%
2
   0.4%
HPV-16/18, overall Number Analyzed 2093 participants 2081 participants
2
   0.1%
43
   2.1%
HPV-16, overall Number Analyzed 2043 participants 2030 participants
1
   0.0%
30
   1.5%
HPV-18, overall Number Analyzed 2077 participants 2057 participants
1
   0.0%
13
   0.6%
38.Secondary Outcome
Title Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
Hide Description Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Time Frame Up to Month 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2125 2111
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 2073 participants 2055 participants
7
   0.3%
60
   2.9%
HPV-18 Number Analyzed 2108 participants 2085 participants
2
   0.1%
23
   1.1%
HPV-31 Number Analyzed 2073 participants 2090 participants
10
   0.5%
29
   1.4%
HPV-33 Number Analyzed 2105 participants 2094 participants
12
   0.6%
9
   0.4%
HPV-35 Number Analyzed 2112 participants 2101 participants
11
   0.5%
17
   0.8%
HPV-39 Number Analyzed 2097 participants 2078 participants
34
   1.6%
26
   1.3%
HPV-45 Number Analyzed 2106 participants 2088 participants
9
   0.4%
30
   1.4%
HPV-51 Number Analyzed 2071 participants 2072 participants
48
   2.3%
42
   2.0%
HPV-52 Number Analyzed 2060 participants 2058 participants
54
   2.6%
56
   2.7%
HPV-56 Number Analyzed 2100 participants 2081 participants
28
   1.3%
30
   1.4%
HPV-58 Number Analyzed 2098 participants 2092 participants
24
   1.1%
19
   0.9%
HPV-59 Number Analyzed 2105 participants 2083 participants
22
   1.0%
21
   1.0%
HPV-66 Number Analyzed 2089 participants 2080 participants
45
   2.2%
49
   2.4%
HPV-68 Number Analyzed 2084 participants 2085 participants
31
   1.5%
33
   1.6%
HPV-31/45 Number Analyzed 2121 participants 2109 participants
19
   0.9%
57
   2.7%
HPV-31/45/33/52/58 Number Analyzed 2125 participants 2111 participants
98
   4.6%
128
   6.1%
HPV-39/45/59/68 Number Analyzed 2125 participants 2111 participants
92
   4.3%
102
   4.8%
HPV-31/33/35/52/58 Number Analyzed 2125 participants 2111 participants
101
   4.8%
118
   5.6%
HPV-31/45/33/52/58/35/39/51/56/59 Number Analyzed 2125 participants 2111 participants
206
   9.7%
220
  10.4%
HPV-HRW Number Analyzed 2125 participants 2111 participants
255
  12.0%
274
  13.0%
HPV-HR Number Analyzed 2125 participants 2111 participants
262
  12.3%
330
  15.6%
39.Secondary Outcome
Title Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
Hide Description Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68
Time Frame Up to Month 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2094 2083
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 2043 participants 2030 participants
1
   0.0%
30
   1.5%
HPV-18 Number Analyzed 2077 participants 2057 participants
1
   0.0%
13
   0.6%
HPV-31 Number Analyzed 2044 participants 2062 participants
7
   0.3%
17
   0.8%
HPV-33 Number Analyzed 2074 participants 2068 participants
9
   0.4%
7
   0.3%
HPV-35 Number Analyzed 2081 participants 2073 participants
5
   0.2%
9
   0.4%
HPV-39 Number Analyzed 2067 participants 2050 participants
20
   1.0%
10
   0.5%
HPV-45 Number Analyzed 2076 participants 2060 participants
7
   0.3%
13
   0.6%
HPV-51 Number Analyzed 2040 participants 2045 participants
23
   1.1%
26
   1.3%
HPV-52 Number Analyzed 2029 participants 2031 participants
34
   1.7%
31
   1.5%
HPV-56 Number Analyzed 2071 participants 2054 participants
11
   0.5%
15
   0.7%
HPV-58 Number Analyzed 2067 participants 2065 participants
14
   0.7%
13
   0.6%
HPV-59 Number Analyzed 2074 participants 2055 participants
7
   0.3%
10
   0.5%
HPV-66 Number Analyzed 2058 participants 2052 participants
22
   1.1%
16
   0.8%
HPV-68 Number Analyzed 2053 participants 2057 participants
13
   0.6%
22
   1.1%
HPV-31/45 Number Analyzed 2091 participants 2081 participants
14
   0.7%
28
   1.3%
HPV-31/45/33/52/58 Number Analyzed 2094 participants 2083 participants
65
   3.1%
75
   3.6%
HPV-39/45/59/68 Number Analyzed 2094 participants 2083 participants
46
   2.2%
54
   2.6%
HPV-31/33/35/52/58 Number Analyzed 2094 participants 2083 participants
64
   3.1%
72
   3.5%
HPV-31/45/33/52/58/35/39/51/56/59 Number Analyzed 2094 participants 2083 participants
118
   5.6%
129
   6.2%
HPV-HRW Number Analyzed 2094 participants 2083 participants
145
   6.9%
160
   7.7%
HPV-HR Number Analyzed 2094 participants 2083 participants
147
   7.0%
194
   9.3%
40.Secondary Outcome
Title Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Hide Description CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Note: Results for seropositive status were not analysed.
Time Frame Up to Month 84
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
Arm/Group Title Cervarix Group Aluminium Hydroxide Group
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Number of Participants Analyzed 2168 2146
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- and sero- subjects Number Analyzed 1852 participants 1818 participants
1
   0.1%
6
   0.3%
HPV-16, DNA- and sero- subjects Number Analyzed 1507 participants 1491 participants
1
   0.1%
5
   0.3%
HPV-18, DNA- and sero- subjects Number Analyzed 1565 participants 1541 participants
1
   0.1%
2
   0.1%
HPV-16/18, overall Number Analyzed 2168 participants 2146 participants
1
   0.0%
8
   0.4%
HPV-16, overall Number Analyzed 2112 participants 2090 participants
1
   0.0%
5
   0.2%
HPV-18, overall Number Analyzed 2149 participants 2122 participants
1
   0.0%
4
   0.2%
41.Secondary Outcome
Title Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Hide