Trial Outcomes & Findings for Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs (NCT NCT00541970)

NCT ID: NCT00541970

Last Updated: 2018-08-17

Results Overview

Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

961 participants

Primary outcome timeframe

One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).

Results posted on

2018-08-17

Participant Flow

The study included two phases, an active vaccination phase (Months 0-7) followed by a safety follow-up phase (up to the end of the study at Month 60).

The study was run in an open manner for subjects in the groups receiving the Cervarix vaccine on a 3-dose vaccination schedule. For subjects in the group receiving the Cervarix vaccine on a 2-dose vaccination schedule, the study was run in an observer-blind manner until Month 24, and then in an open manner.

Participant milestones

Participant milestones
Measure	Cervarix 1/Placebo Group Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Month 7 STARTED	240	241	240	239
Month 7 COMPLETED	231	228	229	234
Month 7 NOT COMPLETED	9	13	11	5
Month 12 STARTED	240	241	240	239
Month 12 COMPLETED	228	219	219	223
Month 12 NOT COMPLETED	12	22	21	16
Month 18 STARTED	240	241	240	239
Month 18 COMPLETED	226	217	215	222
Month 18 NOT COMPLETED	14	24	25	17
Month 24 STARTED	240	241	240	239
Month 24 COMPLETED	211	209	208	217
Month 24 NOT COMPLETED	29	32	32	22
Month 36 STARTED	240	241	240	239
Month 36 COMPLETED	179	175	174	179
Month 36 NOT COMPLETED	61	66	66	60
Month 48 STARTED	240	241	240	239
Month 48 COMPLETED	169	168	167	164
Month 48 NOT COMPLETED	71	73	73	75
Month 60 STARTED	240	241	240	239
Month 60 COMPLETED	162	164	158	167
Month 60 NOT COMPLETED	78	77	82	72

Reasons for withdrawal

Reasons for withdrawal
Measure	Cervarix 1/Placebo Group Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Month 7 Protocol Violation	9	13	11	5
Month 12 Adverse Event	0	1	1	1
Month 12 Protocol Violation	12	21	20	15
Month 18 Adverse Event	0	1	1	1
Month 18 Protocol Violation	14	23	24	16
Month 24 Adverse Event	0	1	1	1
Month 24 Protocol Violation	29	31	31	21
Month 36 Protocol Violation	61	66	66	60
Month 48 Withdrawal by Subject	2	4	4	2
Month 48 Other	3	1	1	0
Month 48 Lost to Follow-up	66	68	68	73
Month 60 Protocol Violation	78	77	82	72

Baseline Characteristics

Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cervarix 1/Placebo Group n=240 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=241 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=240 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=239 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.	Total n=960 Participants Total of all reporting groups
Age, Continuous	17.1 Years STANDARD_DEVIATION 4.30 • n=5 Participants	17.2 Years STANDARD_DEVIATION 4.30 • n=7 Participants	17.3 Years STANDARD_DEVIATION 4.25 • n=5 Participants	17.2 Years STANDARD_DEVIATION 4.38 • n=4 Participants	17.2 Years STANDARD_DEVIATION 4.31 • n=21 Participants
Sex: Female, Male Female	240 Participants n=5 Participants	241 Participants n=7 Participants	240 Participants n=5 Participants	239 Participants n=4 Participants	960 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).

Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=224 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=206 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=204 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=208 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies Anti-HPV-18	3543.2 EL.U/mL Interval 3126.6 to 4015.3	5997.5 EL.U/mL Interval 5310.9 to 6772.8	4811.4 EL.U/mL Interval 4282.7 to 5405.3	5087.1 EL.U/mL Interval 4460.2 to 5802.1
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies Anti-HPV-16	5844.6 EL.U/mL Interval 5259.6 to 6494.7	10500.9 EL.U/mL Interval 9356.9 to 11784.8	7741.6 EL.U/mL Interval 6868.2 to 8726.1	13045.3 EL.U/mL Interval 11211.4 to 15179.2

PRIMARY outcome

Timeframe: Within 7 days (Day 0-6) after vaccination.

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented. Analysis for this outcome was done on subjects with available results for this outcome measure.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling larger than (\>) 50 millimeters (mm).

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=238 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=239 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=238 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=238 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms Any Pain	222 Participants	225 Participants	222 Participants	225 Participants
Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms Any Swelling	92 Participants	88 Participants	83 Participants	118 Participants
Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms Grade 3 Pain	18 Participants	27 Participants	26 Participants	35 Participants
Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms Any Redness	109 Participants	112 Participants	123 Participants	145 Participants
Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms Redness > 50 mm	3 Participants	4 Participants	1 Participants	3 Participants
Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms Swelling > 50 mm	4 Participants	3 Participants	1 Participants	5 Participants

PRIMARY outcome

Timeframe: Within 7 days (Day 0-6) after vaccination.

Assessed solicited general symptoms were arthralgia, fatigue, fever (defined as axillary temperature equal or above (≥) 37.5 degrees Celsius (°C), gastrointestinal symptoms, which included nausea, vomiting, diarrhoea and/or abdominal pain, headache, myalgia, rash and urticaria. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related symptom = symptom assessed by the investigator to be causally related to vaccination.

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=238 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=239 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=238 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=238 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia	45 Participants	57 Participants	39 Participants	43 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia	39 Participants	43 Participants	35 Participants	35 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever (Axillary Temperature >= 37.5°C)	23 Participants	20 Participants	22 Participants	39 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever (Axillary Temperature >= 39.0°C)	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal Symptoms	3 Participants	7 Participants	2 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	101 Participants	116 Participants	112 Participants	125 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	79 Participants	81 Participants	91 Participants	95 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia	3 Participants	9 Participants	6 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Rash	8 Participants	9 Participants	8 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Urticaria	2 Participants	4 Participants	4 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia	0 Participants	3 Participants	4 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	100 Participants	109 Participants	104 Participants	107 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	76 Participants	82 Participants	87 Participants	83 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	11 Participants	4 Participants	5 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	18 Participants	15 Participants	16 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal Symptoms	48 Participants	48 Participants	36 Participants	68 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal Symptoms	36 Participants	43 Participants	27 Participants	50 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	9 Participants	9 Participants	7 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia	79 Participants	109 Participants	98 Participants	99 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia	62 Participants	87 Participants	75 Participants	77 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Rash	12 Participants	12 Participants	10 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Urticaria	1 Participants	3 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: At Month 3, 1 month after the second dose of vaccine or placebo

Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The analysis was performed on the subjects who were administered a 2-dose vaccination schedule.

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=224 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=206 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=203 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies . Anti-HPV-16	5844.6 EL.U/mL Interval 5259.6 to 6494.7	397.9 EL.U/mL Interval 337.4 to 469.2	266.4 EL.U/mL Interval 227.2 to 312.4	—
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies . Anti-HPV-18	3543.2 EL.U/mL Interval 3126.6 to 4015.3	228.3 EL.U/mL Interval 196.7 to 265.0	181.9 EL.U/mL Interval 156.8 to 211.1	—

SECONDARY outcome

Timeframe: At Month 7, 1 month after the last dose of vaccine or placebo.

Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). Groups were stratified into 3 age strata: 9-14, 15-19 and 20-25 years of age at the time of first vaccination. The 15-19 years age stratum in the group receiving the Cervarix vaccine on a 3-dose vaccination schedule was considered an active comparator.

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=221 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=206 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=204 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=208 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies 9-14 years, Anti-HPV-16	2003.9 EL.U/mL Interval 1635.7 to 2455.0	15028.4 EL.U/mL Interval 12611.3 to 17908.6	11058.6 EL.U/mL Interval 9273.8 to 13186.7	22066.3 EL.U/mL Interval 18140.7 to 26841.2
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies 15-19 years, Anti-HPV-16	1168.5 EL.U/mL Interval 957.4 to 1426.2	10818.7 EL.U/mL Interval 8979.8 to 13034.2	7869.6 EL.U/mL Interval 6488.9 to 9543.9	12817.4 EL.U/mL Interval 9723.2 to 16896.2
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies 20-25 years, Anti-HPV-16	1371.2 EL.U/mL Interval 1092.2 to 1721.6	7331.4 EL.U/mL Interval 5965.2 to 9010.4	5209.2 EL.U/mL Interval 4166.5 to 6512.7	7370.0 EL.U/mL Interval 5673.6 to 9573.6
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies 15-19 years, Anti-HPV-18	719.8 EL.U/mL Interval 571.2 to 907.0	6170.1 EL.U/mL Interval 5046.8 to 7543.5	5039.3 EL.U/mL Interval 4283.4 to 5928.5	4907.0 EL.U/mL Interval 3780.8 to 6368.7
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies 9-14 years, Anti-HPV-18	1134.3 EL.U/mL Interval 922.8 to 1394.3	8085.8 EL.U/mL Interval 6654.5 to 9825.0	5630.7 EL.U/mL Interval 4772.1 to 6643.7	7192.9 EL.U/mL Interval 5952.6 to 8691.6
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies 20-25 years, Anti-HPV-18	656.5 EL.U/mL Interval 514.6 to 837.5	4389.6 EL.U/mL Interval 3525.6 to 5465.4	3889.2 EL.U/mL Interval 2980.9 to 5074.3	3576.8 EL.U/mL Interval 2886.5 to 4432.2

SECONDARY outcome

Timeframe: At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.

Population: The analysis was performed on the According-to-Protocol cohort for Immunogenicity, which included all evaluable subjects eligible for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=216 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=198 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=195 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=198 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies Anti-HPV-16 at Month 24	821.2 EL.U/mL Interval 718.5 to 938.5	1756.4 EL.U/mL Interval 1556.6 to 1981.9	1285.1 EL.U/mL Interval 1139.6 to 1449.2	2425.9 EL.U/mL Interval 2071.1 to 2841.5
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies Anti-HPV-18 at Month 36	302.2 EL.U/mL Interval 254.9 to 358.2	712.8 EL.U/mL Interval 605.4 to 839.3	617.9 EL.U/mL Interval 532.3 to 717.2	874.2 EL.U/mL Interval 734.9 to 1040.0
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies Anti-HPV-18 at Month 48	260.4 EL.U/mL Interval 218.5 to 310.2	626.3 EL.U/mL Interval 531.0 to 738.7	517.0 EL.U/mL Interval 446.2 to 599.1	723.2 EL.U/mL Interval 607.2 to 861.4
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies Anti-HPV-18 at Month 18	389.2 EL.U/mL Interval 338.7 to 447.2	1025.2 EL.U/mL Interval 889.0 to 1182.2	883.1 EL.U/mL Interval 774.7 to 1006.8	1096.6 EL.U/mL Interval 939.4 to 1280.1
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies Anti-HPV-16 at Month 12	1064.7 EL.U/mL Interval 937.5 to 1209.1	3256.0 EL.U/mL Interval 2918.8 to 3632.1	2438.7 EL.U/mL Interval 2167.2 to 2744.2	4726.7 EL.U/mL Interval 4036.8 to 5534.6
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies Anti-HPV-16 at Month 18	968.1 EL.U/mL Interval 845.2 to 1109.0	2229.4 EL.U/mL Interval 1983.2 to 2506.2	1659.1 EL.U/mL Interval 1466.9 to 1876.4	3185.1 EL.U/mL Interval 2735.1 to 3709.2
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies Anti-HPV-16 at Month 36	688.3 EL.U/mL Interval 592.2 to 799.9	1462.2 EL.U/mL Interval 1288.8 to 1658.8	1094.0 EL.U/mL Interval 961.1 to 1245.1	2195.4 EL.U/mL Interval 1850.8 to 2604.1
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies Anti-HPV-16 at Month 48	649.5 EL.U/mL Interval 556.0 to 758.8	1261.2 EL.U/mL Interval 1106.4 to 1437.7	953.5 EL.U/mL Interval 835.5 to 1088.2	1892.3 EL.U/mL Interval 1594.2 to 2246.0
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies Anti-HPV-18 at Month 12	472.9 EL.U/mL Interval 410.5 to 544.8	1760.1 EL.U/mL Interval 1531.5 to 2022.8	1426.2 EL.U/mL Interval 1250.8 to 1626.1	1714.5 EL.U/mL Interval 1469.7 to 2000.0
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies Anti-HPV-18 at Month 24	345.9 EL.U/mL Interval 299.3 to 399.8	818.2 EL.U/mL Interval 706.5 to 947.5	674.6 EL.U/mL Interval 591.8 to 769.0	866.8 EL.U/mL Interval 741.2 to 1013.6

SECONDARY outcome

Timeframe: At Month 7, 1 month after the last dose of vaccine or placebo.

Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=221 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=206 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=204 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=208 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies Anti-HPV-16	1677.5 EL.U/mL Interval 1677.5 to 1677.5	11784.8 EL.U/mL Interval 11784.8 to 11784.8	8726.1 EL.U/mL Interval 8726.1 to 8726.1	15179.2 EL.U/mL Interval 15179.2 to 15179.2
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies Anti-HPV-18	817.3 EL.U/mL Interval 715.6 to 933.4	5997.5 EL.U/mL Interval 5310.9 to 6772.8	4811.4 EL.U/mL Interval 4282.7 to 5405.3	5087.1 EL.U/mL Interval 4460.2 to 5802.1

SECONDARY outcome

Timeframe: At Month 7 (M7)

Assessed parameters were alanine aminotransferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocritis (Hct), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range. This outcome presents BAS results.

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=223 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=221 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=221 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=225 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. BAS, PRE NORMAL, M7 NORMAL	219 Participants	214 Participants	208 Participants	214 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. BAS, PRE NORMAL, M7 BELOW	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. BAS, PRE NORMAL, M7 ABOVE	2 Participants	3 Participants	6 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. BAS, PRE NORMAL, M7 MISSING	1 Participants	2 Participants	4 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. BAS, PRE BELOW, M7 NORMAL	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. BAS, PRE BELOW, M7 BELOW	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. BAS, PRE BELOW, M7 ABOVE	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. BAS, PRE ABOVE, M7 NORMAL	1 Participants	2 Participants	2 Participants	4 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. BAS, PRE ABOVE, M7 BELOW	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. BAS, PRE ABOVE, M7 ABOVE	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 7 (M7)

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=226 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=225 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=228 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=229 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. CREA, PRE NORMAL, M7 MISSING	1 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. CREA, PRE ABOVE, M7 ABOVE	1 Participants	3 Participants	2 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. CREA, PRE NORMAL, M7 NORMAL	202 Participants	200 Participants	210 Participants	206 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. CREA, PRE NORMAL, M7 BELOW	7 Participants	4 Participants	3 Participants	6 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. CREA, PRE NORMAL, M7 ABOVE	5 Participants	7 Participants	1 Participants	4 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. CREA, PRE BELOW, M7 NORMAL	6 Participants	3 Participants	3 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. CREA, PRE BELOW, M7 BELOW	2 Participants	4 Participants	4 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. CREA, PRE BELOW, M7 ABOVE	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. CREA, PRE BELOW, M7 MISSING	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. CREA, PRE ABOVE, M7 NORMAL	2 Participants	4 Participants	4 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. CREA, PRE ABOVE, M7 BELOW	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 7 (M7)

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=226 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=223 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=223 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=226 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. EOS, PRE NORMAL, M7 NORMAL	203 Participants	207 Participants	200 Participants	205 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. EOS, PRE NORMAL, M7 BELOW	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. EOS, PRE NORMAL, M7 ABOVE	5 Participants	6 Participants	8 Participants	6 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. EOS, PRE NORMAL, M7 MISSING	1 Participants	1 Participants	4 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. EOS, PRE BELOW, M7 NORMAL	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. EOS, PRE BELOW, M7 BELOW	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. EOS, PRE BELOW, M7 ABOVE	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. EOS, PRE ABOVE, M7 BELOW	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. EOS, PRE ABOVE, M7 MISSING	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. EOS, PRE ABOVE, M7 NORMAL	8 Participants	3 Participants	3 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. EOS, PRE ABOVE, M7 ABOVE	8 Participants	3 Participants	7 Participants	5 Participants

SECONDARY outcome

Timeframe: At Month 7 (M7)

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=229 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=228 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=227 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=233 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. Hct, PRE NORMAL, M7 BELOW	6 Participants	5 Participants	8 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. Hct, PRE BELOW, M7 NORMAL	3 Participants	5 Participants	4 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. Hct, PRE BELOW, M7 ABOVE	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. Hct, PRE ABOVE, M7 ABOVE	1 Participants	5 Participants	2 Participants	6 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. Hct, PRE NORMAL, M7 NORMAL	196 Participants	193 Participants	189 Participants	208 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. Hct, PRE NORMAL, M7 ABOVE	11 Participants	8 Participants	7 Participants	6 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. Hct, PRE NORMAL, M7 MISSING	2 Participants	2 Participants	4 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. Hct, PRE BELOW, M7 BELOW	3 Participants	2 Participants	3 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. Hct, PRE ABOVE, M7 NORMAL	7 Participants	8 Participants	10 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. Hct, PRE ABOVE, M7 BELOW	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 7 (M7)

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=229 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=227 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=229 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=233 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. ALT, PRE NORMAL, M7 NORMAL	211 Participants	211 Participants	213 Participants	209 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. ALT, PRE NORMAL, M7 BELOW	3 Participants	2 Participants	4 Participants	4 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. ALT, PRE BELOW, M7 NORMAL	0 Participants	2 Participants	0 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. ALT, PRE BELOW, M7 BELOW	1 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. ALT, PRE BELOW, M7 ABOVE	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. ALT, PRE ABOVE, M7 NORMAL	9 Participants	4 Participants	1 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. ALT, PRE ABOVE, M7 BELOW	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. ALT, PRE ABOVE, M7 ABOVE	4 Participants	1 Participants	2 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. ALT, PRE ABOVE, M7 MISSING	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. ALT, PRE NORMAL, M7 ABOVE	1 Participants	6 Participants	7 Participants	5 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. ALT, PRE NORMAL, M7 MISSING	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 7 (M7)

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=226 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=223 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=223 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=227 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. LYM, PRE ABOVE, M7 BELOW	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. LYM, PRE ABOVE, M7 ABOVE	4 Participants	2 Participants	5 Participants	4 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. LYM, PRE NORMAL, M7 NORMAL	201 Participants	202 Participants	192 Participants	202 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. LYM, PRE NORMAL, M7 BELOW	3 Participants	0 Participants	3 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. LYM, PRE NORMAL, M7 ABOVE	6 Participants	7 Participants	5 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. LYM, PRE NORMAL, M7 MISSING	1 Participants	2 Participants	4 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. LYM, PRE BELOW, M7 NORMAL	4 Participants	3 Participants	3 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. LYM, PRE BELOW, M7 BELOW	2 Participants	0 Participants	2 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. LYM, PRE BELOW, M7 ABOVE	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. LYM, PRE ABOVE, M7 NORMAL	5 Participants	7 Participants	8 Participants	5 Participants

SECONDARY outcome

Timeframe: At Month 7 (M7)

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=226 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=223 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=223 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=227 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. MON, PRE NORMAL, M7 NORMAL	212 Participants	202 Participants	197 Participants	208 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. MON, PRE NORMAL, M7 MISSING	1 Participants	2 Participants	3 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. MON, PRE NORMAL, M7 ABOVE	4 Participants	6 Participants	9 Participants	6 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. MON, PRE NORMAL, M7 BELOW	0 Participants	1 Participants	2 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. MON, PRE BELOW, M7 NORMAL	1 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. MON, PRE BELOW, M7 BELOW	2 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. MON, PRE BELOW, M7 ABOVE	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. MON, PRE ABOVE, M7 NORMAL	5 Participants	6 Participants	6 Participants	4 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. MON, PRE ABOVE], M7 BELOW	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. MON, PRE ABOVE, M7 ABOVE	1 Participants	4 Participants	5 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. MON, PRE ABOVE, M7 MISSING	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 7 (M7)

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=224 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=223 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=223 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=226 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. NEU, PRE NORMAL, M7 ABOVE	5 Participants	1 Participants	1 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. NEU, PRE BELOW, M7 BELOW	2 Participants	4 Participants	7 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. NEU, PRE ABOVE, M7 NORMAL	6 Participants	5 Participants	5 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. NEU, PRE ABOVE, M7 BELOW	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. NEU, PRE NORMAL, M7 NORMAL	184 Participants	188 Participants	185 Participants	186 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. NEU, PRE NORMAL, M7 BELOW	16 Participants	16 Participants	9 Participants	9 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. NEU, PRE NORMAL, M7 MISSING	1 Participants	2 Participants	7 Participants	6 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. NEU, PRE BELOW, M7 NORMAL	8 Participants	6 Participants	9 Participants	15 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. NEU, PRE BELOW, M7 ABOVE	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. NEU, PRE ABOVE, M7 ABOVE	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. NEU, PRE BELOW, M7 MISSING	1 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At Month 7 (M7)

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=229 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=228 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=228 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=233 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. RBC, PRE NORMAL, M7 NORMAL	204 Participants	204 Participants	196 Participants	213 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. RBC, PRE NORMAL, M7 BELOW	7 Participants	7 Participants	2 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. RBC, PRE NORMAL, M7 ABOVE	2 Participants	3 Participants	2 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. RBC, PRE NORMAL, M7 MISSING	1 Participants	1 Participants	4 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. RBC, PRE BELOW, M7 NORMAL	4 Participants	3 Participants	2 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. RBC, PRE BELOW, M7 BELOW	2 Participants	3 Participants	10 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. RBC, PRE BELOW, M7 ABOVE	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. RBC, PRE ABOVE, M7 NORMAL	5 Participants	4 Participants	6 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. RBC, PRE ABOVE, M7 BELOW	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. RBC, PRE ABOVE, M7 ABOVE	4 Participants	3 Participants	6 Participants	1 Participants

SECONDARY outcome

Timeframe: At Month 7 (M7)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented, on subjects with available results.

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=229 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=228 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=229 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=233 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. WBC, PRE NORMAL, M7 ABOVE	5 Participants	4 Participants	8 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. WBC, PRE NORMAL, M7 MISSING	1 Participants	1 Participants	4 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. WBC, PRE BELOW, M7 BELOW	4 Participants	4 Participants	3 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. WBC, PRE ABOVE, M7 BELOW	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. WBC, PRE NORMAL, M7 NORMAL	197 Participants	199 Participants	194 Participants	212 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. WBC, PRE NORMAL, M7 BELOW	4 Participants	9 Participants	5 Participants	9 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. WBC, PRE BELOW, M7 NORMAL	4 Participants	5 Participants	3 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. WBC, PRE BELOW, M7 ABOVE	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. WBC, PRE ABOVE, M7 NORMAL	10 Participants	4 Participants	9 Participants	4 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. WBC, PRE ABOVE, M7 ABOVE	4 Participants	2 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 7 (M7)

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=226 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=227 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=228 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=232 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. PLA, PRE NORMAL, M7 MISSING	1 Participants	2 Participants	4 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. PLA, PRE BELOW, M7 NORMAL	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. PLA, PRE BELOW, M7 BELOW	0 Participants	3 Participants	0 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. PLA, PRE BELOW, M7 ABOVE	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. PLA, PRE ABOVE, M7 NORMAL	9 Participants	11 Participants	8 Participants	4 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. PLA, PRE ABOVE, M7 ABOVE	6 Participants	3 Participants	5 Participants	4 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. PLA, PRE NORMAL, M7 NORMAL	204 Participants	204 Participants	206 Participants	218 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. PLA, PRE NORMAL, M7 BELOW	1 Participants	2 Participants	3 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. PLA, PRE NORMAL, M7 ABOVE	5 Participants	2 Participants	2 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed. PLA, PRE ABOVE, M7 BELOW	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Month 12, at Month 18, at Month 24, at Month 36, and at Month 48 during the safety follow-up phase.

Seroconversion was defined as the appearance of antibodies (i.e.titers greater than or equal to (≥) cut-off value) in the serum of subjects seronegative before vaccination. Assay cut-off was defined as ≥ 8 ELISA units per milliliter (EL.U/mL) for HPV-16, and 7 EL.U/mL for HPV-18. Seronegative subjects are subjects who had an antibody concentration below cut-off value. Cut-off values were 8 EL.U/mL for antibody concentrations against HPV-16, and 7 EL.U/mL for antibody concentrations against HPV-18.

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=216 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=198 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=195 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=198 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18) Anti-HPV-16 at Month 12	194 Participants	162 Participants	172 Participants	169 Participants
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18) Anti-HPV-16 at Month 18	192 Participants	166 Participants	172 Participants	168 Participants
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18) Anti-HPV-16 at Month 24	185 Participants	155 Participants	165 Participants	162 Participants
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18) Anti-HPV-16 at Month 36	156 Participants	135 Participants	146 Participants	135 Participants
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18) Anti-HPV-16 at Month 48	149 Participants	130 Participants	139 Participants	129 Participants
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18) Anti-HPV-18 at Month 12	187 Participants	173 Participants	166 Participants	173 Participants
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18) Anti-HPV-18 at Month 18	184 Participants	177 Participants	166 Participants	173 Participants
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18) Anti-HPV-18 at Month 24	173 Participants	165 Participants	159 Participants	166 Participants
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18) Anti-HPV-18 at Month 36	144 Participants	145 Participants	139 Participants	132 Participants
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18) Anti-HPV-18 at Month 48	138 Participants	139 Participants	135 Participants	129 Participants

SECONDARY outcome

Timeframe: At Month 60 of the safety follow-up phase

Population: The analysis was performed on the ATP cohort for Immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The assay cut-off for Month 60 was defined as ≥ 19 ELISA units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=137 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=134 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=131 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=146 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies Anti-HPV-16 at Month 60	658.0 EL.U/mL Interval 560.4 to 772.5	1254.0 EL.U/mL Interval 1088.5 to 1444.8	976.1 EL.U/mL Interval 846.1 to 1126.1	1858.5 EL.U/mL Interval 1586.2 to 2177.6
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies Anti-HPV-18 at Month 60	269.4 EL.U/mL Interval 223.0 to 325.5	622.2 EL.U/mL Interval 519.0 to 745.9	557.9 EL.U/mL Interval 473.7 to 657.0	745.3 EL.U/mL Interval 629.3 to 882.7

SECONDARY outcome

Timeframe: At Month 60 of the safety follow-up phase

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=130 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=122 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=119 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=127 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18) Anti-HPV-18 at Month 60	116 Participants	122 Participants	116 Participants	125 Participants
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18) Anti-HPV-16 at Month 60	130 Participants	114 Participants	119 Participants	127 Participants

SECONDARY outcome

Timeframe: From Month 0 to Month 48.

Population: The analysis was performed on pregnant subjects in the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.

Pregnancy outcomes were ectopic pregnancy, elective termination with no apparent congenital anomaly (ACA), elective termination with congenital anomaly (CA), lost to follow up, pregnancy ongoing, spontaneous abortion with no ACA and live infant with no ACA.

Outcome measures

Outcome measures
Measure	Cervarix 1/Placebo Group n=23 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 1/Placebo/Cervarix 1 Group n=16 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2/Placebo/Cervarix 2 Group n=24 Participants Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.	Cervarix 2 Group n=20 Participants Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
Number of Subjects With Pregnancy Outcomes. Ectopic pregnancy	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Pregnancy Outcomes. Pregnancy ongoing	0 Participants	1 Participants	2 Participants	2 Participants
Number of Subjects With Pregnancy Outcomes. Spontaneous abortion with NO ACA	1 Participants	0 Participants	3 Participants	1 Participants
Number of Subjects With Pregnancy Outcomes. Elective termination with NO ACA	5 Participants	3 Participants	3 Participants	5 Participants
Number of Subjects With Pregnancy Outcomes. Elective termination with CA	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Pregnancy Outcomes. Live infant with NO ACA	15 Participants	12 Participants	15 Participants	12 Participants
Number of Subjects With Pregnancy Outcomes. Lost to follow up	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Throughout the study period, from Month 0 to Month 60.

Population: The analysis was performed on pregnant subjects in the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.