Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine

A Long-term, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Novel HPV Vaccine in Healthy Female Subjects Vaccinated in the Primary Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00359619

Enrollment

383

Registered

2006-08-02

Start date

2006-09-12

Completion date

2007-01-30

Last updated

2020-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Papillomavirus, Papillomavirus Vaccines

Keywords

HPV vaccine

Brief summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Interventions

BIOLOGICALCervarixTM

Subjects were administered three doses of HPV vaccine

BIOLOGICALHPV investigational vaccine GSK568893A, different formulations

Subjects were administered three doses of HPV investigational vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 25 Years

Healthy volunteers

Yes

Inclusion criteria

* A female who enrolled in the study 102115 and received three doses of vaccine. * Written informed consent obtained from the subject prior to enrolment.

Exclusion criteria

* Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine). * Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling. * Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling. * Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period.

Design outcomes

Primary

Measure	Time frame	Description
Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	At Months 18, 24, 36 and 48.	Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	At Months 18, 24, 36 and 48.	Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	At Months 18, 24, 36 and 48.	Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	At Months 18, 24, 36 and 48.	Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	At Months 18, 24, 36 and 48.	Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	At Months 18, 24, 36 and 48.	Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.

Secondary

Measure	Time frame	Description
Number of Subjects With Any Serious Adverse Events (SAEs).	From Month 0 to Months 18, 24, 36 and 48	SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject. Any = Occurrence of any symptom regardless of intensity grade.
Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	At Months 18, 24, 36 and 48.	Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
Number of Subjects With Pregnancy Outcomes.	From Month 0 to Month 18	Pregnancy outcomes were healthy baby, spontaneous abortion and elective abortion.
Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	At Months 18, 24, 36 and 48.	Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	At Months 18, 24, 36 and 48.	Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 59 EL.U/mL.
Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	At Months 18, 24, 36 and 48.	Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.
Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	From Month 0 to Months 18, 24, 36 and 48	NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. At least one NOCD = At least one NOCD experienced (regardless of the Medical Dictionary for Regulatory Activities \[MedDRA\] Preferred Term)
Number of Subjects With at Least One Medically Significant Condition (MAEs).	From Month 0 to Months 18, 24, 36 and 48	MAEs were defined as adverse events (AEs) prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (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. At least one MAE = At least one medically significant AE experienced (regardless of the MedDRA Preferred Term).

Countries

Belgium, United States

Participant flow

Recruitment details

The study is a safety follow-up of the primary study NCT00231413, starting from Month 18 post-vaccination.

Pre-assignment details

A total number of 383 subjects were enrolled in the primary study. A total of 193, 216, 182 and 166 subjects attended Month 18, Month 24, Month 36 and Month 48 visits, respectively. No separate demography data was tabulated for these intermediate timepoints, as statistics were computed only after the last study visit at Month 48.

Participants by arm

Arm	Count
Cervarix Group Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	88
Cervarix 1 Group Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	50
Cervarix 2 Group Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	49
Cervarix 3 Group Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	48
Cervarix 4 Group Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	48
Cervarix 5 Group Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	50
Cervarix 6 Group Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.	50
Total	383

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006
Overall Study	Adverse Event	0	0	1	0	0	0	1
Overall Study	Lost to Follow-up	4	4	2	1	1	5	0
Overall Study	Other	1	0	0	0	0	0	0
Overall Study	Withdrawal by Subject	3	1	4	2	2	0	3

Baseline characteristics

Characteristic	Cervarix Group	Cervarix 1 Group	Cervarix 2 Group	Cervarix 3 Group	Cervarix 4 Group	Cervarix 5 Group	Cervarix 6 Group	Total
Age, Continuous	20.9 Years STANDARD_DEVIATION 2.03	21.5 Years STANDARD_DEVIATION 2.18	21.2 Years STANDARD_DEVIATION 2.07	21.1 Years STANDARD_DEVIATION 2.09	21.4 Years STANDARD_DEVIATION 2.27	21.2 Years STANDARD_DEVIATION 2.26	20.7 Years STANDARD_DEVIATION 1.91	21.1 Years STANDARD_DEVIATION 2.11
Sex: Female, Male Female	88 Participants	50 Participants	49 Participants	48 Participants	48 Participants	50 Participants	50 Participants	383 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	6 / 88	4 / 50	2 / 49	6 / 48	3 / 48	1 / 50	1 / 50

Outcome results

Primary

Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies

Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.

Time frame: At Months 18, 24, 36 and 48.

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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)	1902.6 Titers
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)	1472.8 Titers
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)	1291.7 Titers
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)	1248.8 Titers
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)	1558.5 Titers
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)	1223.4 Titers
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)	1031.2 Titers
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)	955.5 Titers
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)	1347.4 Titers
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)	1791.7 Titers
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)	1104.9 Titers
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)	1032.9 Titers
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)	1107.7 Titers
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)	1552.9 Titers
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)	1579.5 Titers
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)	1097.4 Titers
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)	1242.8 Titers
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)	1092.8 Titers
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)	911.3 Titers
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)	841.4 Titers
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)	1310.1 Titers
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)	1869.6 Titers
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)	1672.2 Titers
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)	1381.9 Titers
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)	1128.6 Titers
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)	1130.2 Titers
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)	1764.4 Titers
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies	Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)	1150.4 Titers

Primary

Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.

Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.

Time frame: At Months 18, 24, 36 and 48.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 24 (N=28,12,11,9,16,15,15)	1477.1 EL.U/mL
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 18 (N=27,10,9,8,14,13,13)	1933.9 EL.U/mL
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 48 (N=28,12,11,9,16,15,15)	1300.9 EL.U/mL
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 36 (N=28,12,11,9,16,15,15)	1296.8 EL.U/mL
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 36 (N=28,12,11,9,16,15,15)	1200.5 EL.U/mL
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 18 (N=27,10,9,8,14,13,13)	1868.3 EL.U/mL
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 48 (N=28,12,11,9,16,15,15)	1115.4 EL.U/mL
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 24 (N=28,12,11,9,16,15,15)	1381.6 EL.U/mL
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 36 (N=28,12,11,9,16,15,15)	1023.1 EL.U/mL
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 24 (N=28,12,11,9,16,15,15)	1339.9 EL.U/mL
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 48 (N=28,12,11,9,16,15,15)	1007.5 EL.U/mL
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 18 (N=27,10,9,8,14,13,13)	1902.3 EL.U/mL
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 18 (N=27,10,9,8,14,13,13)	1996.4 EL.U/mL
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 24 (N=28,12,11,9,16,15,15)	1520.6 EL.U/mL
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 36 (N=28,12,11,9,16,15,15)	1275.3 EL.U/mL
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 48 (N=28,12,11,9,16,15,15)	1337.7 EL.U/mL
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 24 (N=28,12,11,9,16,15,15)	1264.4 EL.U/mL
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 48 (N=28,12,11,9,16,15,15)	1070.8 EL.U/mL
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 36 (N=28,12,11,9,16,15,15)	960.6 EL.U/mL
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 18 (N=27,10,9,8,14,13,13)	1437.1 EL.U/mL
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 24 (N=28,12,11,9,16,15,15)	1817.8 EL.U/mL
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 48 (N=28,12,11,9,16,15,15)	1417.8 EL.U/mL
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 36 (N=28,12,11,9,16,15,15)	1521.8 EL.U/mL
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 18 (N=27,10,9,8,14,13,13)	2200.3 EL.U/mL
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 48 (N=28,12,11,9,16,15,15)	1105.5 EL.U/mL
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 18 (N=27,10,9,8,14,13,13)	1769.8 EL.U/mL
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 24 (N=28,12,11,9,16,15,15)	1585.6 EL.U/mL
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16 Month 36 (N=28,12,11,9,16,15,15)	1076.9 EL.U/mL

Primary

Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies

Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.

Time frame: At Months 18, 24, 36 and 48.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)	994.4 Titers
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)	666.3 Titers
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)	683.5 Titers
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)	739.5 Titers
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)	355.2 Titers
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)	284.6 Titers
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)	525.5 Titers
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)	320.5 Titers
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)	297.7 Titers
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)	410.5 Titers
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)	349.8 Titers
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)	524.1 Titers
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)	465.1 Titers
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)	536.7 Titers
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)	424.6 Titers
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)	443.3 Titers
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)	442.1 Titers
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)	348.1 Titers
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)	551.1 Titers
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)	329.7 Titers
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)	574.9 Titers
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)	412.0 Titers
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)	426.1 Titers
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)	497.7 Titers
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 48 (N=33,18,16,18,18,20,19)	330.2 Titers
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 18 (N=32,15,13,16,16,17,17)	570.5 Titers
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 24 (N=33,18,16,18,18,20,19)	425.4 Titers
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies	Anti-HPV-16 Month 36 (N=33,18,16,18,18,20,19)	364.9 Titers

Primary

Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.

Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.

Time frame: At Months 18, 24, 36 and 48.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)	1060.9 EL.U/mL
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)	781.7 EL.U/mL
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)	733.6 EL.U/mL
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)	729.3 EL.U/mL
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)	248.6 EL.U/mL
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)	286.1 EL.U/mL
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)	469.3 EL.U/mL
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)	321.2 EL.U/mL
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)	333.4 EL.U/mL
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)	387.0 EL.U/mL
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)	532.5 EL.U/mL
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)	278.3 EL.U/mL
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)	536.7 EL.U/mL
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)	465.1 EL.U/mL
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)	424.6 EL.U/mL
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)	443.3 EL.U/mL
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)	563.7 EL.U/mL
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)	382.0 EL.U/mL
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)	502.4 EL.U/mL
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)	381.7 EL.U/mL
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)	536.5 EL.U/mL
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)	637.9 EL.U/mL
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)	456.5 EL.U/mL
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)	440.7 EL.U/mL
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)	356.7 EL.U/mL
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)	572.2 EL.U/mL
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)	419.7 EL.U/mL
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)	320.9 EL.U/mL

Primary

Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.

Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).

Time frame: At Months 18, 24, 36 and 48.

Arm	Measure	Group	Value (NUMBER)
Cervarix Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 18 (N=27,10,9,8,14,13,13)	27 subjects
Cervarix Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 24 (N=28,12,11,9,16,15,15)	28 subjects
Cervarix Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 36 (N=28,12,11,9,16,15,15)	28 subjects
Cervarix Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 48 (N=28,12,11,9,16,15,15)	28 subjects
Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 36 (N=28,12,11,9,16,15,15)	12 subjects
Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 48 (N=28,12,11,9,16,15,15)	12 subjects
Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 18 (N=27,10,9,8,14,13,13)	10 subjects
Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 24 (N=28,12,11,9,16,15,15)	12 subjects
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 36 (N=28,12,11,9,16,15,15)	11 subjects
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 48 (N=28,12,11,9,16,15,15)	11 subjects
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 18 (N=27,10,9,8,14,13,13)	9 subjects
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 24 (N=28,12,11,9,16,15,15)	11 subjects
Cervarix 3 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 18 (N=27,10,9,8,14,13,13)	8 subjects
Cervarix 3 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 24 (N=28,12,11,9,16,15,15)	9 subjects
Cervarix 3 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 48 (N=28,12,11,9,16,15,15)	9 subjects
Cervarix 3 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 36 (N=28,12,11,9,16,15,15)	9 subjects
Cervarix 4 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 24 (N=28,12,11,9,16,15,15)	16 subjects
Cervarix 4 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 18 (N=27,10,9,8,14,13,13)	14 subjects
Cervarix 4 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 36 (N=28,12,11,9,16,15,15)	16 subjects
Cervarix 4 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 48 (N=28,12,11,9,16,15,15)	16 subjects
Cervarix 5 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 24 (N=28,12,11,9,16,15,15)	15 subjects
Cervarix 5 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 18 (N=27,10,9,8,14,13,13)	13 subjects
Cervarix 5 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 48 (N=28,12,11,9,16,15,15)	15 subjects
Cervarix 5 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 36 (N=28,12,11,9,16,15,15)	15 subjects
Cervarix 6 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 24 (N=28,12,11,9,16,15,15)	15 subjects
Cervarix 6 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 48 (N=28,12,11,9,16,15,15)	15 subjects
Cervarix 6 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 36 (N=28,12,11,9,16,15,15)	15 subjects
Cervarix 6 Group	Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.	Anti-HPV-16, Month 18 (N=27,10,9,8,14,13,13)	13 subjects

Primary

Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.

Time frame: At Months 18, 24, 36 and 48.

Arm	Measure	Group	Value (NUMBER)
Cervarix Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)	26 subjects
Cervarix Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)	26 subjects
Cervarix Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)	26 subjects
Cervarix Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)	26 subjects
Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)	13 subjects
Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)	10 subjects
Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)	13 subjects
Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)	13 subjects
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)	12 subjects
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)	14 subjects
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)	14 subjects
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)	14 subjects
Cervarix 3 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)	18 subjects
Cervarix 3 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)	18 subjects
Cervarix 3 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)	16 subjects
Cervarix 3 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)	18 subjects
Cervarix 4 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)	12 subjects
Cervarix 4 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)	11 subjects
Cervarix 4 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)	12 subjects
Cervarix 4 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)	12 subjects
Cervarix 5 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)	18 subjects
Cervarix 5 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)	15 subjects
Cervarix 5 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)	18 subjects
Cervarix 5 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)	18 subjects
Cervarix 6 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 24 (N=26,13,14,18,12,18,17)	17 subjects
Cervarix 6 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 18 (N=26,10,12,16,11,15,15)	15 subjects
Cervarix 6 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 48 (N=26,13,14,18,12,18,17)	17 subjects
Cervarix 6 Group	Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.	Anti-HPV-18 Month 36 (N=26,13,14,18,12,18,17)	17 subjects

Secondary

Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.

Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.

Time frame: At Months 18, 24, 36 and 48.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)	187.7 EL.U/mL.
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)	174.7 EL.U/mL.
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)	164.6 EL.U/mL.
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)	125.3 EL.U/mL.
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)	1336.1 EL.U/mL.
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)	1284.5 EL.U/mL.
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)	1776.8 EL.U/mL.
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)	1346.7 EL.U/mL.
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)	2105.3 EL.U/mL.
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)	2076.2 EL.U/mL.
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)	1776.6 EL.U/mL.
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)	2685.9 EL.U/mL.
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)	1966.7 EL.U/mL.
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)	2388.8 EL.U/mL.
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)	1744.2 EL.U/mL.
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)	1644.0 EL.U/mL.
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)	2298.0 EL.U/mL.
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)	1825.1 EL.U/mL.
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)	2714.9 EL.U/mL.
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)	2126.9 EL.U/mL.
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)	1952.4 EL.U/mL.
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)	1434.2 EL.U/mL.
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)	1584.1 EL.U/mL.
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)	1911.8 EL.U/mL.
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)	2118.1 EL.U/mL.
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)	3466.4 EL.U/mL.
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)	2518.3 EL.U/mL.
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)	2080.0 EL.U/mL.

Secondary

Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.

Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 59 EL.U/mL.

Time frame: At Months 18, 24, 36 and 48.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)	184.8 EL.U/mL
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)	138.3 EL.U/mL
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)	165.4 EL.U/mL
Cervarix Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)	190.7 EL.U/mL
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)	659.0 EL.U/mL
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)	707.8 EL.U/mL
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)	919.8 EL.U/mL
Cervarix 1 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)	713.0 EL.U/mL
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)	1103.9 EL.U/mL
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)	1274.5 EL.U/mL
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)	1731.0 EL.U/mL
Cervarix 2 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)	1036.2 EL.U/mL
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)	959.1 EL.U/mL
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)	904.9 EL.U/mL
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)	810.7 EL.U/mL
Cervarix 3 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)	806.9 EL.U/mL
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)	1086.6 EL.U/mL
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)	815.1 EL.U/mL
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)	948.1 EL.U/mL
Cervarix 4 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)	825.2 EL.U/mL
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)	1106.5 EL.U/mL
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)	1235.8 EL.U/mL
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)	1015.6 EL.U/mL
Cervarix 5 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)	914.6 EL.U/mL
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)	774.7 EL.U/mL
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)	1094.9 EL.U/mL
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)	848.2 EL.U/mL
Cervarix 6 Group	Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)	750.0 EL.U/mL

Secondary

Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.

Time frame: At Months 18, 24, 36 and 48.

Arm	Measure	Group	Value (NUMBER)
Cervarix Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)	25 subjects
Cervarix Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)	22 subjects
Cervarix Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)	23 subjects
Cervarix Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)	23 subjects
Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)	16 subjects
Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)	16 subjects
Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)	13 subjects
Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)	16 subjects
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)	15 subjects
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)	15 subjects
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)	12 subjects
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)	15 subjects
Cervarix 3 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)	13 subjects
Cervarix 3 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)	15 subjects
Cervarix 3 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)	15 subjects
Cervarix 3 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)	15 subjects
Cervarix 4 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)	14 subjects
Cervarix 4 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)	16 subjects
Cervarix 4 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)	16 subjects
Cervarix 4 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)	16 subjects
Cervarix 5 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)	17 subjects
Cervarix 5 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)	15 subjects
Cervarix 5 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)	18 subjects
Cervarix 5 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)	18 subjects
Cervarix 6 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 36 (N=28,16,15,15,16,18,19)	19 subjects
Cervarix 6 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 18 (N=27,13,12,13,14,15,17)	17 subjects
Cervarix 6 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 24 (N=28,16,15,15,16,17,19)	19 subjects
Cervarix 6 Group	Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.	Anti-HPV-31 Month 48 (N=28,16,15,15,16,18,19)	19 subjects

Secondary

Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.

Time frame: At Months 18, 24, 36 and 48.

Arm	Measure	Group	Value (NUMBER)
Cervarix Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)	19 subjects
Cervarix Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)	18 subjects
Cervarix Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)	20 subjects
Cervarix Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)	19 subjects
Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)	17 subjects
Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)	14 subjects
Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)	17 subjects
Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)	17 subjects
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)	10 subjects
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)	12 subjects
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)	12 subjects
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)	12 subjects
Cervarix 3 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)	13 subjects
Cervarix 3 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)	11 subjects
Cervarix 3 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)	13 subjects
Cervarix 3 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)	13 subjects
Cervarix 4 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)	16 subjects
Cervarix 4 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)	14 subjects
Cervarix 4 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)	16 subjects
Cervarix 4 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)	16 subjects
Cervarix 5 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)	17 subjects
Cervarix 5 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)	18 subjects
Cervarix 5 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)	15 subjects
Cervarix 5 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)	18 subjects
Cervarix 6 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 48 (N=19,17,12,13,16,18,16)	16 subjects
Cervarix 6 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 18 (N=20,14,10,11,14,15,15)	15 subjects
Cervarix 6 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 24 (N=19,17,12,13,16,17,16)	16 subjects
Cervarix 6 Group	Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.	Anti-HPV-45 Month 36 (N=18,17,12,13,16,18,16)	16 subjects

Secondary

Number of Subjects With Any Serious Adverse Events (SAEs).

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity, or are a congenital anomaly/birth defect in the offspring of a study subject. Any = Occurrence of any symptom regardless of intensity grade.

Time frame: From Month 0 to Months 18, 24, 36 and 48

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

Arm	Measure	Group	Value (NUMBER)
Cervarix Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 18	2 subjects
Cervarix Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 24	2 subjects
Cervarix Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 36	2 subjects
Cervarix Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 48	6 subjects
Cervarix 1 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 48	4 subjects
Cervarix 1 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 36	3 subjects
Cervarix 1 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 18	3 subjects
Cervarix 1 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 24	3 subjects
Cervarix 2 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 36	2 subjects
Cervarix 2 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 24	1 subjects
Cervarix 2 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 18	1 subjects
Cervarix 2 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 48	2 subjects
Cervarix 3 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 18	3 subjects
Cervarix 3 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 24	3 subjects
Cervarix 3 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 36	4 subjects
Cervarix 3 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 48	6 subjects
Cervarix 4 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 18	2 subjects
Cervarix 4 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 48	3 subjects
Cervarix 4 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 24	3 subjects
Cervarix 4 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 36	3 subjects
Cervarix 5 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 24	1 subjects
Cervarix 5 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 18	0 subjects
Cervarix 5 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 36	1 subjects
Cervarix 5 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 48	1 subjects
Cervarix 6 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 36	1 subjects
Cervarix 6 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 18	1 subjects
Cervarix 6 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 24	1 subjects
Cervarix 6 Group	Number of Subjects With Any Serious Adverse Events (SAEs).	Any SAE(s) at Month 48	1 subjects

Secondary

Number of Subjects With at Least One Medically Significant Condition (MAEs).

MAEs were defined as adverse events (AEs) prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (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. At least one MAE = At least one medically significant AE experienced (regardless of the MedDRA Preferred Term).

Time frame: From Month 0 to Months 18, 24, 36 and 48

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

Arm	Measure	Group	Value (NUMBER)
Cervarix Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 18	4 subjects
Cervarix Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 24	6 subjects
Cervarix Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 36	9 subjects
Cervarix Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 48	14 subjects
Cervarix 1 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 48	7 subjects
Cervarix 1 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 36	4 subjects
Cervarix 1 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 18	3 subjects
Cervarix 1 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 24	3 subjects
Cervarix 2 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 36	3 subjects
Cervarix 2 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 24	3 subjects
Cervarix 2 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 18	2 subjects
Cervarix 2 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 48	5 subjects
Cervarix 3 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 18	4 subjects
Cervarix 3 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 24	7 subjects
Cervarix 3 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 36	7 subjects
Cervarix 3 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 48	9 subjects
Cervarix 4 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 18	5 subjects
Cervarix 4 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 48	12 subjects
Cervarix 4 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 24	8 subjects
Cervarix 4 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 36	9 subjects
Cervarix 5 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 24	5 subjects
Cervarix 5 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 18	1 subjects
Cervarix 5 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 36	5 subjects
Cervarix 5 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 48	5 subjects
Cervarix 6 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 36	2 subjects
Cervarix 6 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 18	1 subjects
Cervarix 6 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 24	1 subjects
Cervarix 6 Group	Number of Subjects With at Least One Medically Significant Condition (MAEs).	MAE(s) at Month 48	3 subjects

Secondary

Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)

NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. At least one NOCD = At least one NOCD experienced (regardless of the Medical Dictionary for Regulatory Activities \[MedDRA\] Preferred Term)

Time frame: From Month 0 to Months 18, 24, 36 and 48

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

Arm	Measure	Group	Value (NUMBER)
Cervarix Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 24	6 subjects
Cervarix Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 48	7 subjects
Cervarix Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 36	7 subjects
Cervarix Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 18	6 subjects
Cervarix 1 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 48	1 subjects
Cervarix 1 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 24	1 subjects
Cervarix 1 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 36	1 subjects
Cervarix 1 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 18	1 subjects
Cervarix 2 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 48	7 subjects
Cervarix 2 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 18	6 subjects
Cervarix 2 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 24	6 subjects
Cervarix 2 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 36	6 subjects
Cervarix 3 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 24	2 subjects
Cervarix 3 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 18	2 subjects
Cervarix 3 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 48	3 subjects
Cervarix 3 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 36	2 subjects
Cervarix 4 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 48	4 subjects
Cervarix 4 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 24	3 subjects
Cervarix 4 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 36	3 subjects
Cervarix 4 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 18	3 subjects
Cervarix 5 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 36	1 subjects
Cervarix 5 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 48	1 subjects
Cervarix 5 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 24	1 subjects
Cervarix 5 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 18	1 subjects
Cervarix 6 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 48	4 subjects
Cervarix 6 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 18	2 subjects
Cervarix 6 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 24	2 subjects
Cervarix 6 Group	Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)	NOCD(s) at Month 36	3 subjects

Secondary

Number of Subjects With Pregnancy Outcomes.

Pregnancy outcomes were normal infant, abnormal infant/congenital anomaly, spontaneous abortion and elective termination.

Time frame: From Month 0 to Month 48

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

Arm	Measure	Group	Value (NUMBER)
Cervarix Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix Group	Number of Subjects With Pregnancy Outcomes.	Normal infant	9 subjects
Cervarix Group	Number of Subjects With Pregnancy Outcomes.	Elective termination	1 subjects
Cervarix Group	Number of Subjects With Pregnancy Outcomes.	Abnormal infant/congenital anomaly	1 subjects
Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination	0 subjects
Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Abnormal infant/congenital anomaly	1 subjects
Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Normal infant	6 subjects
Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Abnormal infant/congenital anomaly	0 subjects
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Normal infant	3 subjects
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination	0 subjects
Cervarix 3 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	1 subjects
Cervarix 3 Group	Number of Subjects With Pregnancy Outcomes.	Normal infant	2 subjects
Cervarix 3 Group	Number of Subjects With Pregnancy Outcomes.	Abnormal infant/congenital anomaly	0 subjects
Cervarix 3 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination	1 subjects
Cervarix 4 Group	Number of Subjects With Pregnancy Outcomes.	Abnormal infant/congenital anomaly	0 subjects
Cervarix 4 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination	1 subjects
Cervarix 4 Group	Number of Subjects With Pregnancy Outcomes.	Normal infant	0 subjects
Cervarix 4 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	1 subjects
Cervarix 5 Group	Number of Subjects With Pregnancy Outcomes.	Abnormal infant/congenital anomaly	0 subjects
Cervarix 5 Group	Number of Subjects With Pregnancy Outcomes.	Normal infant	1 subjects
Cervarix 5 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 5 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination	1 subjects
Cervarix 6 Group	Number of Subjects With Pregnancy Outcomes.	Abnormal infant/congenital anomaly	0 subjects
Cervarix 6 Group	Number of Subjects With Pregnancy Outcomes.	Normal infant	4 subjects
Cervarix 6 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination	0 subjects
Cervarix 6 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects

Secondary

Number of Subjects With Pregnancy Outcomes.

Pregnancy outcomes were healthy baby, spontaneous abortion and elective abortion.

Time frame: From Month 0 to Month 18

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

Arm	Measure	Group	Value (NUMBER)
Cervarix Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	1 subjects
Cervarix Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	3 subjects
Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	0 subjects
Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	2 subjects
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 3 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 3 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	1 subjects
Cervarix 3 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects
Cervarix 4 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	1 subjects
Cervarix 4 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	0 subjects
Cervarix 4 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects
Cervarix 5 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 5 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	1 subjects
Cervarix 5 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects
Cervarix 6 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	3 subjects
Cervarix 6 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects
Cervarix 6 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects

Secondary

Number of Subjects With Pregnancy Outcomes.

Pregnancy outcomes were healthy baby, spontaneous abortion, elective abortion and ongoing pregnancy.

Time frame: From Month 0 to Month 24

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

Arm	Measure	Group	Value (NUMBER)
Cervarix Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix Group	Number of Subjects With Pregnancy Outcomes.	Ongoing pregnancy	0 subjects
Cervarix Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	1 subjects
Cervarix Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	4 subjects
Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	1 subjects
Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects
Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Ongoing pregnancy	0 subjects
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Ongoing pregnancy	0 subjects
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	2 subjects
Cervarix 3 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects
Cervarix 3 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	2 subjects
Cervarix 3 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 3 Group	Number of Subjects With Pregnancy Outcomes.	Ongoing pregnancy	1 subjects
Cervarix 4 Group	Number of Subjects With Pregnancy Outcomes.	Ongoing pregnancy	0 subjects
Cervarix 4 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	0 subjects
Cervarix 4 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects
Cervarix 4 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	1 subjects
Cervarix 5 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	1 subjects
Cervarix 5 Group	Number of Subjects With Pregnancy Outcomes.	Ongoing pregnancy	0 subjects
Cervarix 5 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects
Cervarix 5 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 6 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 6 Group	Number of Subjects With Pregnancy Outcomes.	Ongoing pregnancy	0 subjects
Cervarix 6 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	3 subjects
Cervarix 6 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects

Secondary

Number of Subjects With Pregnancy Outcomes.

Pregnancy outcomes were healthy baby, abnormal infant/congenital anomaly, spontaneous abortion and elective abortion.

Time frame: From Month 0 to Month 36

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

Arm	Measure	Group	Value (NUMBER)
Cervarix Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	1 subjects
Cervarix Group	Number of Subjects With Pregnancy Outcomes.	Abnormal infant/congenital anomaly	1 subjects
Cervarix Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	4 subjects
Cervarix Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	4 subjects
Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects
Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Abnormal infant/congenital anomaly	0 subjects
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	3 subjects
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Abnormal infant/congenital anomaly	0 subjects
Cervarix 3 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	1 subjects
Cervarix 3 Group	Number of Subjects With Pregnancy Outcomes.	Abnormal infant/congenital anomaly	0 subjects
Cervarix 3 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	2 subjects
Cervarix 3 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 4 Group	Number of Subjects With Pregnancy Outcomes.	Abnormal infant/congenital anomaly	0 subjects
Cervarix 4 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	0 subjects
Cervarix 4 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	1 subjects
Cervarix 4 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects
Cervarix 5 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 5 Group	Number of Subjects With Pregnancy Outcomes.	Abnormal infant/congenital anomaly	0 subjects
Cervarix 5 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	1 subjects
Cervarix 5 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects
Cervarix 6 Group	Number of Subjects With Pregnancy Outcomes.	Healthy baby	3 subjects
Cervarix 6 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion	0 subjects
Cervarix 6 Group	Number of Subjects With Pregnancy Outcomes.	Abnormal infant/congenital anomaly	0 subjects
Cervarix 6 Group	Number of Subjects With Pregnancy Outcomes.	Elective abortion	0 subjects

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies

Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.

Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies

Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.

Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.

Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.

Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.

Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.

Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.

Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.

Number of Subjects With Any Serious Adverse Events (SAEs).

Number of Subjects With at Least One Medically Significant Condition (MAEs).

Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)

Number of Subjects With Pregnancy Outcomes.

Number of Subjects With Pregnancy Outcomes.

Number of Subjects With Pregnancy Outcomes.

Number of Subjects With Pregnancy Outcomes.