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

• ClinicalTrials.gov Identifier: NCT00294047
• Recruitment Status: Completed
• First Posted: February 20, 2006
• Results First Posted: March 27, 2012
• Last Update Posted: January 2, 2020
• Sponsor: GlaxoSmithKline
• 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
• Conditions: Infections, Papillomavirus; Papillomavirus Vaccines
• Interventions: Biological: Cervarix; Biological: Placebo control
• Enrollment: 5752

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Cervarix Group	Aluminium Hydroxide Group	Total
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
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%

Outcome Measures

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.
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

Outcome Measure Data

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
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).
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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).
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
Description	Detection was done on all subjects irrespective of their baseline HPV DNA status.
Time Frame	Up to Month 48

Outcome Measure Data

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
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
Description	Detection was done on all subjects irrespective of their baseline HPV DNA status.
Time Frame	Up to Month 48

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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).
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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.
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.

Outcome Measure Data

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
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.
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.

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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).
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.

Outcome Measure Data

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
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).
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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).
Description	NOCDs include autoimmune disorders, asthma and type I diabetes.
Time Frame	Up to Month 48

Outcome Measure Data

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
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).
Description	[Not Specified]
Time Frame	Up to Month 48

Outcome Measure Data

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
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).
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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)
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; the same HPV type was found in at least one of the two (closest) preceding cytology samples, or; 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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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.
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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 84

Outcome Measure Data

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
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
		2 0.1%	12 0.7%
HPV-16, DNA- and sero- subjects	Number Analyzed	1507 participants	1491 participants
		1 0.1%	9 0.6%
HPV-18, DNA- and sero- subjects	Number Analyzed	1565 participants	1541 participants
		2 0.1%	4 0.3%
HPV-16/18, DNA- and sero+ subjects	Number Analyzed	870 participants	848 participants
		0 0.0%	3 0.4%
HPV-16, DNA- and sero+ subjects	Number Analyzed	588 participants	583 participants
		0 0.0%	1 0.2%
HPV-18, DNA- and sero+ subjects	Number Analyzed	552 participants	539 participants
		0 0.0%	2 0.4%
HPV-16/18, overall	Number Analyzed	2168 participants	2146 participants
		2 0.1%	16 0.7%
HPV-16, overall	Number Analyzed	2112 participants	2090 participants
		1 0.0%	10 0.5%
HPV-18, overall	Number Analyzed	2149 participants	2122 participants
		2 0.1%	7 0.3%

42. 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
Description	[Not Specified]
Time Frame	Up to Month 84

Outcome Measure Data

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
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	2733	2735
Measure Type: Count of Participants; Unit of Measure: Participants
HPV-16/18	37 1.4%	66 2.4%
HPV-16	26 1.0%	49 1.8%
HPV-18	14 0.5%	23 0.8%

43. 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
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 84

Outcome Measure Data

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
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	2733	2735
Measure Type: Count of Participants; Unit of Measure: Participants
	179 6.5%	229 8.4%

44. Secondary Outcome

Title	Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
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 84

Outcome Measure Data

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
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
		3 0.2%	47 2.6%
HPV-16, DNA- and sero- subjects	Number Analyzed	1507 participants	1491 participants
		3 0.2%	34 2.3%
HPV-18, DNA- and sero- subjects	Number Analyzed	1565 participants	1541 participants
		0 0.0%	14 0.9%
HPV-16/18, overall	Number Analyzed	2168 participants	2146 participants
		6 0.3%	56 2.6%
HPV-16	Number Analyzed	2112 participants	2090 participants
		5 0.2%	38 1.8%
HPV-18	Number Analyzed	2149 participants	2122 participants
		1 0.0%	19 0.9%

45. Secondary Outcome

Title	Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
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

Outcome Measure Data

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
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		2169	2148
Measure Type: Count of Participants; Unit of Measure: Participants
HPV-16	Number Analyzed	2112 participants	2090 participants
		5 0.2%	38 1.8%
HPV-18	Number Analyzed	2149 participants	2122 participants
		1 0.0%	19 0.9%
HPV-31	Number Analyzed	2117 participants	2127 participants
		5 0.2%	23 1.1%
HPV-33	Number Analyzed	2149 participants	2130 participants
		6 0.3%	8 0.4%
HPV-35	Number Analyzed	2156 participants	2137 participants
		7 0.3%	13 0.6%
HPV-39	Number Analyzed	2141 participants	2114 participants
		21 1.0%	23 1.1%
HPV-45	Number Analyzed	2150 participants	2125 participants
		5 0.2%	23 1.1%
HPV-51	Number Analyzed	2115 participants	2107 participants
		38 1.8%	34 1.6%
HPV-52	Number Analyzed	2103 participants	2095 participants
		25 1.2%	22 1.1%
HPV-56	Number Analyzed	2114 participants	2115 participants
		15 0.7%	28 1.3%
HPV-58	Number Analyzed	2142 participants	2128 participants
		19 0.9%	13 0.6%
HPV-59	Number Analyzed	2147 participants	2120 participants
		9 0.4%	22 1.0%
HPV-66	Number Analyzed	2133 participants	2117 participants
		22 1.0%	43 2.0%
HPV-68	Number Analyzed	2128 participants	2120 participants
		15 0.7%	15 0.7%
HPV-31/45	Number Analyzed	2165 participants	2146 participants
		10 0.5%	44 2.1%
HPV-31/45/33/52/58	Number Analyzed	2169 participants	2148 participants
		56 2.6%	78 3.6%
HPV-39/45/59/68	Number Analyzed	2169 participants	2148 participants
		49 2.3%	74 3.4%
HPV-31/33/35/52/58	Number Analyzed	2169 participants	2148 participants
		56 2.6%	70 3.3%
HPV-31/45/33/52/58/35/39/51/56/59	Number Analyzed	2169 participants	2148 participants
		119 5.5%	160 7.4%
HPV-HRW	Number Analyzed	2169 participants	2148 participants
		143 6.6%	192 8.9%
HPV-HR	Number Analyzed	2169 participants	2148 participants