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

Evaluation of the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine 580299 When Administered in Healthy Females Aged 9 - 25 Years Using an Alternative Schedule and an Alternative Dosing as Compared to the Standard Schedule and Dosing

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00541970

Enrollment

961

Registered

2007-10-10

Start date

2007-10-17

Completion date

2013-03-18

Last updated

2018-08-17

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

Conditions

Infections, Papillomavirus

Keywords

viral infections, Human Papillomavirus (HPV) vaccine, safety, vaccine, immunogenicity, cervical cancer

Brief summary

Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GlaxoSmithKline (GSK) Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. In previous trials this vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities and cervical dysplasia. In this partially-blind study, GSK Biologicals will evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and an alternative dosing when administered in healthy young females aged 9 to 25 years, as compared to the standard HPV vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following a protocol amendment.

Interventions

BIOLOGICALCervarix

Intramuscular injection, different dosing /schedule

DRUGPlacebo

Intramuscular injection, different dosing /schedule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

9 Years to 25 Years

Healthy volunteers

Yes

Inclusion criteria

* Subjects who the investigator believes that they and/or their parents can and will comply with the requirements of the protocol should be enrolled in the study. * A female subject between, and including, 9 and 25 years of age at the time of the first vaccination. * Written informed consent/assent obtained from the subject prior to enrolment. For subjects above the legal age of consent, written informed consent must be obtained from the subject. For subjects below the legal age of consent, written informed consent from the subject's parents/legally acceptable representative, and written informed assent must be obtained from the subject. * Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study. * Subject must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.

Exclusion criteria

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 24). * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Concurrently participating in another clinical study, at any time during the study period (up to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine. Planned administration/administration of routine vaccines, up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window. * Pregnant or breastfeeding female. * A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose. * Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (up to Month 24). * Previous administration of components of the investigational vaccine. * Cancer or autoimmune disease under treatment. * Any medically diagnosed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Hypersensitivity to latex. * Acute disease at the time of enrolment. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period (up to Month 24).

Design outcomes

Primary

Measure	Time frame	Description
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).	Titers are given as Geometric Mean Titers (GMTs) expressed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Within 7 days (Day 0-6) after vaccination.	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).
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	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.

Secondary

Measure	Time frame	Description
Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	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.
Number of Subjects With Pregnancy Outcomes.	From Month 0 to Month 48.	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.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).	Within 30 days (Day 0-29) after vaccination.	An unsolicited adverse event (AE) is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 = an event that prevented normal activity. Related = an event assessed by the investigator as causally related to the study vaccination.
Number of Subjects With Medically Significant Conditions (MSCs).	From Month 0 to Month 7.	MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .	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.
Number of Subjects With New Onset of Autoimune Diseases (NOADs)	From Month 0 to Month 48.	NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Number of Subjects With New Onset of Chronic Diseases (NOCDs)	From Month 0 to Month 7.	NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Number of Subjects With Serious Adverse Events (SAEs).	From Month 0 to Month 7.	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.
Number of Subjects With Serious Adverse Events (SAEs)	Throughout the study period, from Month 0 to Month 60.	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.
Number of Subjects With New Onset of Autoimmune Diseases (NOADs)	From Month 0 to Month 7.	NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.
Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	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.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	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.

Countries

Canada, Germany

Participant flow

Recruitment details

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).

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	240
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.	241
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.	240
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.	239
Total	960

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
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	Lost to Follow-up	66	68	68	73
Month 48	Other	3	1	1	0
Month 48	Withdrawal by Subject	2	4	4	2
Month 60	Protocol Violation	78	77	82	72
Month 7	Protocol Violation	9	13	11	5

Baseline characteristics

Characteristic	Cervarix 1/Placebo Group	Cervarix 1/Placebo/Cervarix 1 Group	Cervarix 2/Placebo/Cervarix 2 Group	Cervarix 2 Group	Total
Age, Continuous	17.1 Years STANDARD_DEVIATION 4.3	17.2 Years STANDARD_DEVIATION 4.3	17.3 Years STANDARD_DEVIATION 4.25	17.2 Years STANDARD_DEVIATION 4.38	17.2 Years STANDARD_DEVIATION 4.31
Sex: Female, Male Female	240 Participants	241 Participants	240 Participants	239 Participants	960 Participants
Sex: Female, Male Male	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
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	229 / 240	233 / 241	228 / 240	233 / 239
serious Total, serious adverse events	14 / 240	16 / 241	19 / 240	15 / 239

Outcome results

Primary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

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.

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever (Axillary Temperature >= 37.5°C)	23 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Arthralgia	39 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Arthralgia	0 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fatigue	100 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fatigue	76 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fatigue	11 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Arthralgia	45 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever	18 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever (Axillary Temperature >= 39.0°C)	1 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Gastrointestinal Symptoms	48 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Gastrointestinal Symptoms	36 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Gastrointestinal Symptoms	3 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Headache	101 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Headache	79 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Headache	9 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Myalgia	79 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Myalgia	62 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Myalgia	3 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Rash	12 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Rash	8 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Rash	0 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Urticaria	2 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Urticaria	1 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Urticaria	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Urticaria	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Headache	116 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fatigue	109 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Urticaria	3 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Urticaria	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Headache	81 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever (Axillary Temperature >= 39.0°C)	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Myalgia	87 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fatigue	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Headache	9 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Arthralgia	3 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Myalgia	109 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Rash	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Gastrointestinal Symptoms	48 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Rash	9 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Arthralgia	43 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever	15 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Gastrointestinal Symptoms	43 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever (Axillary Temperature >= 37.5°C)	20 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Rash	12 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Arthralgia	57 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Gastrointestinal Symptoms	7 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fatigue	82 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Myalgia	9 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Gastrointestinal Symptoms	27 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever (Axillary Temperature >= 37.5°C)	22 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever	16 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever (Axillary Temperature >= 39.0°C)	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Gastrointestinal Symptoms	36 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Rash	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Rash	8 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Gastrointestinal Symptoms	2 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Headache	112 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Headache	91 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Urticaria	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Headache	7 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Myalgia	98 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Urticaria	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Myalgia	75 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Myalgia	6 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Urticaria	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Arthralgia	39 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Arthralgia	35 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Rash	10 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Arthralgia	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fatigue	104 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fatigue	87 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fatigue	5 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Urticaria	3 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Rash	1 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever	27 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Arthralgia	43 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Gastrointestinal Symptoms	50 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Gastrointestinal Symptoms	68 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fatigue	8 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Arthralgia	35 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fatigue	83 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever (Axillary Temperature >= 39.0°C)	0 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Rash	9 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Arthralgia	3 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Urticaria	5 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Headache	12 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Rash	15 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Myalgia	99 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Urticaria	0 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Headache	95 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever (Axillary Temperature >= 37.5°C)	39 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Myalgia	77 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Headache	125 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Gastrointestinal Symptoms	7 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fatigue	107 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Myalgia	7 Participants

Primary

Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms

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).

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Any Pain	222 Participants
Cervarix 1/Placebo Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Grade 3 Pain	18 Participants
Cervarix 1/Placebo Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Any Redness	109 Participants
Cervarix 1/Placebo Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Redness > 50 mm	3 Participants
Cervarix 1/Placebo Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Any Swelling	92 Participants
Cervarix 1/Placebo Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Swelling > 50 mm	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Swelling > 50 mm	3 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Redness > 50 mm	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Any Pain	225 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Any Redness	112 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Grade 3 Pain	27 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Any Swelling	88 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Grade 3 Pain	26 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Any Redness	123 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Redness > 50 mm	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Swelling > 50 mm	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Any Swelling	83 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Any Pain	222 Participants
Cervarix 2 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Any Swelling	118 Participants
Cervarix 2 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Swelling > 50 mm	5 Participants
Cervarix 2 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Grade 3 Pain	35 Participants
Cervarix 2 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Redness > 50 mm	3 Participants
Cervarix 2 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Any Pain	225 Participants
Cervarix 2 Group	Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms	Any Redness	145 Participants

Primary

Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies

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

Time frame: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18	5997.5 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16	10500.9 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16	7741.6 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18	4811.4 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16	13045.3 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18	5087.1 EL.U/mL

Secondary

Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)

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.

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 12	194 Participants
Cervarix 1/Placebo Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 18	192 Participants
Cervarix 1/Placebo Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 24	185 Participants
Cervarix 1/Placebo Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 36	156 Participants
Cervarix 1/Placebo Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 48	149 Participants
Cervarix 1/Placebo Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 12	187 Participants
Cervarix 1/Placebo Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 18	184 Participants
Cervarix 1/Placebo Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 24	173 Participants
Cervarix 1/Placebo Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 36	144 Participants
Cervarix 1/Placebo Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 48	138 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 24	155 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 36	145 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 36	135 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 48	130 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 12	173 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 18	177 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 48	139 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 24	165 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 12	162 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 18	166 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 24	159 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 18	166 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 48	135 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 12	172 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 36	146 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 12	166 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 36	139 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 18	172 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 48	139 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 24	165 Participants
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 48	129 Participants
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 24	166 Participants
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 12	173 Participants
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 48	129 Participants
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 18	173 Participants
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 18	168 Participants
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 24	162 Participants
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 36	135 Participants
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 12	169 Participants
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 36	132 Participants

Secondary

Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 60	130 Participants
Cervarix 1/Placebo Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 60	116 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 60	122 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 60	114 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 60	119 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 60	116 Participants
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-16 at Month 60	127 Participants
Cervarix 2 Group	Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)	Anti-HPV-18 at Month 60	125 Participants

Secondary

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

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 WBC results.

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE NORMAL, M7 BELOW	4 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE BELOW, M7 BELOW	4 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE ABOVE, M7 NORMAL	10 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE NORMAL, M7 MISSING	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE NORMAL, M7 ABOVE	5 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE NORMAL, M7 NORMAL	197 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE BELOW, M7 NORMAL	4 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE ABOVE, M7 ABOVE	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE NORMAL, M7 ABOVE	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE ABOVE, M7 ABOVE	2 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE NORMAL, M7 BELOW	9 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE NORMAL, M7 NORMAL	199 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE BELOW, M7 NORMAL	5 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE BELOW, M7 BELOW	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE NORMAL, M7 MISSING	1 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE ABOVE, M7 NORMAL	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE NORMAL, M7 MISSING	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE ABOVE, M7 ABOVE	3 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE NORMAL, M7 ABOVE	8 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE NORMAL, M7 NORMAL	194 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE ABOVE, M7 NORMAL	9 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE BELOW, M7 NORMAL	3 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE BELOW, M7 BELOW	3 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE NORMAL, M7 BELOW	5 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE ABOVE, M7 ABOVE	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE NORMAL, M7 NORMAL	212 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE NORMAL, M7 BELOW	9 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE NORMAL, M7 ABOVE	3 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE NORMAL, M7 MISSING	1 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE BELOW, M7 NORMAL	3 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE BELOW, M7 BELOW	1 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE ABOVE, M7 NORMAL	4 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	WBC, PRE ABOVE, M7 BELOW	0 Participants

Secondary

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Time frame: At Month 7 (M7)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE NORMAL, M7 NORMAL	219 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE NORMAL, M7 BELOW	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE NORMAL, M7 ABOVE	2 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE NORMAL, M7 MISSING	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE BELOW, M7 NORMAL	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE BELOW, M7 BELOW	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE ABOVE, M7 NORMAL	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE ABOVE, M7 ABOVE	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE NORMAL, M7 ABOVE	3 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE NORMAL, M7 MISSING	2 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE BELOW, M7 NORMAL	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE BELOW, M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE ABOVE, M7 ABOVE	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE ABOVE, M7 NORMAL	2 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE NORMAL, M7 NORMAL	214 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE NORMAL, M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE ABOVE, M7 NORMAL	2 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE ABOVE, M7 ABOVE	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE NORMAL, M7 NORMAL	208 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE NORMAL, M7 MISSING	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE BELOW, M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE NORMAL, M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE BELOW, M7 NORMAL	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE NORMAL, M7 ABOVE	6 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE BELOW, M7 NORMAL	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE ABOVE, M7 NORMAL	4 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE BELOW, M7 BELOW	1 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE ABOVE, M7 ABOVE	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE NORMAL, M7 BELOW	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE NORMAL, M7 ABOVE	3 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE NORMAL, M7 MISSING	3 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE NORMAL, M7 NORMAL	214 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	BAS, PRE ABOVE, M7 BELOW	0 Participants

Secondary

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Time frame: At Month 7 (M7)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE NORMAL, M7 NORMAL	204 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE NORMAL, M7 BELOW	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE NORMAL, M7 ABOVE	5 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE NORMAL, M7 MISSING	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE BELOW, M7 NORMAL	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE BELOW, M7 BELOW	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE ABOVE, M7 NORMAL	9 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE ABOVE, M7 ABOVE	6 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE NORMAL, M7 ABOVE	2 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE NORMAL, M7 MISSING	2 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE BELOW, M7 NORMAL	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE BELOW, M7 BELOW	3 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE ABOVE, M7 ABOVE	3 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE ABOVE, M7 NORMAL	11 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE NORMAL, M7 NORMAL	204 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE NORMAL, M7 BELOW	2 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE ABOVE, M7 NORMAL	8 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE ABOVE, M7 ABOVE	5 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE NORMAL, M7 NORMAL	206 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE NORMAL, M7 MISSING	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE BELOW, M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE NORMAL, M7 BELOW	3 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE BELOW, M7 NORMAL	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE NORMAL, M7 ABOVE	2 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE BELOW, M7 NORMAL	1 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE ABOVE, M7 NORMAL	4 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE BELOW, M7 BELOW	2 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE ABOVE, M7 ABOVE	4 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE NORMAL, M7 BELOW	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE NORMAL, M7 ABOVE	1 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE NORMAL, M7 MISSING	2 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE NORMAL, M7 NORMAL	218 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	PLA, PRE ABOVE, M7 BELOW	0 Participants

Secondary

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Time frame: At Month 7 (M7)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE BELOW, M7 BELOW	2 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE BELOW, M7 NORMAL	6 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE NORMAL, M7 MISSING	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE ABOVE, M7 ABOVE	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE NORMAL, M7 BELOW	7 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE NORMAL, M7 NORMAL	202 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE ABOVE, M7 NORMAL	2 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE BELOW, M7 MISSING	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE NORMAL, M7 ABOVE	5 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE NORMAL, M7 ABOVE	7 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE NORMAL, M7 NORMAL	200 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE NORMAL, M7 BELOW	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE NORMAL, M7 MISSING	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE BELOW, M7 NORMAL	3 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE BELOW, M7 BELOW	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE BELOW, M7 MISSING	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE ABOVE, M7 NORMAL	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE ABOVE, M7 ABOVE	3 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE BELOW, M7 BELOW	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE NORMAL, M7 NORMAL	210 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE BELOW, M7 MISSING	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE NORMAL, M7 BELOW	3 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE ABOVE, M7 NORMAL	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE NORMAL, M7 MISSING	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE ABOVE, M7 ABOVE	2 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE BELOW, M7 NORMAL	3 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE NORMAL, M7 ABOVE	1 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE ABOVE, M7 ABOVE	3 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE NORMAL, M7 ABOVE	4 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE BELOW, M7 BELOW	3 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE BELOW, M7 MISSING	1 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE ABOVE, M7 NORMAL	2 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE NORMAL, M7 BELOW	6 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE NORMAL, M7 NORMAL	206 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE BELOW, M7 NORMAL	2 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	CREA, PRE NORMAL, M7 MISSING	2 Participants

Secondary

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Time frame: At Month 7 (M7)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE NORMAL, M7 NORMAL	203 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE NORMAL, M7 MISSING	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE ABOVE, M7 NORMAL	8 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE NORMAL, M7 BELOW	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE BELOW, M7 ABOVE	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE BELOW, M7 NORMAL	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE NORMAL, M7 ABOVE	5 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE ABOVE, M7 MISSING	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE ABOVE, M7 ABOVE	8 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE BELOW, M7 BELOW	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE BELOW, M7 BELOW	1 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE ABOVE, M7 NORMAL	3 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE NORMAL, M7 ABOVE	6 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE ABOVE, M7 MISSING	1 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE NORMAL, M7 MISSING	1 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE ABOVE, M7 ABOVE	3 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE BELOW, M7 NORMAL	1 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE NORMAL, M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE NORMAL, M7 NORMAL	207 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE ABOVE, M7 ABOVE	7 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE NORMAL, M7 NORMAL	200 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE NORMAL, M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE NORMAL, M7 ABOVE	8 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE NORMAL, M7 MISSING	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE BELOW, M7 NORMAL	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE BELOW, M7 BELOW	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE ABOVE, M7 NORMAL	3 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE ABOVE, M7 MISSING	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE BELOW, M7 BELOW	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE ABOVE, M7 MISSING	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE BELOW, M7 NORMAL	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE NORMAL, M7 MISSING	3 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE NORMAL, M7 ABOVE	6 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE ABOVE, M7 ABOVE	5 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE NORMAL, M7 BELOW	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE NORMAL, M7 NORMAL	205 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE ABOVE, M7 NORMAL	7 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	EOS, PRE BELOW, M7 ABOVE	0 Participants

Secondary

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Time frame: At Month 7 (M7)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE NORMAL, M7 BELOW	6 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE BELOW, M7 NORMAL	3 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE NORMAL, M7 MISSING	2 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE NORMAL, M7 ABOVE	11 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE ABOVE, M7 ABOVE	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE ABOVE, M7 NORMAL	7 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE BELOW, M7 BELOW	3 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE NORMAL, M7 NORMAL	196 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE ABOVE, M7 NORMAL	8 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE NORMAL, M7 NORMAL	193 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE ABOVE, M7 ABOVE	5 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE NORMAL, M7 ABOVE	8 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE NORMAL, M7 MISSING	2 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE BELOW, M7 NORMAL	5 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE BELOW, M7 BELOW	2 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE NORMAL, M7 BELOW	5 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE NORMAL, M7 ABOVE	7 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE ABOVE, M7 ABOVE	2 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE BELOW, M7 BELOW	3 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE NORMAL, M7 BELOW	8 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE NORMAL, M7 MISSING	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE NORMAL, M7 NORMAL	189 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE ABOVE, M7 NORMAL	10 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE BELOW, M7 NORMAL	4 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE ABOVE, M7 ABOVE	6 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE NORMAL, M7 NORMAL	208 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE NORMAL, M7 BELOW	2 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE NORMAL, M7 ABOVE	6 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE NORMAL, M7 MISSING	1 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE BELOW, M7 NORMAL	2 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE BELOW, M7 BELOW	1 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE ABOVE, M7 NORMAL	7 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	Hct, PRE ABOVE, M7 BELOW	0 Participants

Secondary

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Time frame: At Month 7 (M7)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE NORMAL, M7 NORMAL	211 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE NORMAL, M7 MISSING	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE ABOVE, M7 NORMAL	9 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE NORMAL, M7 BELOW	3 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE BELOW, M7 NORMAL	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE NORMAL, M7 ABOVE	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE ABOVE, M7 MISSING	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE ABOVE, M7 ABOVE	4 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE BELOW, M7 BELOW	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE BELOW, M7 BELOW	1 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE ABOVE, M7 NORMAL	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE NORMAL, M7 ABOVE	6 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE ABOVE, M7 MISSING	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE NORMAL, M7 MISSING	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE ABOVE, M7 ABOVE	1 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE BELOW, M7 NORMAL	2 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE NORMAL, M7 BELOW	2 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE NORMAL, M7 NORMAL	211 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE ABOVE, M7 ABOVE	2 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE NORMAL, M7 NORMAL	213 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE NORMAL, M7 BELOW	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE NORMAL, M7 ABOVE	7 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE NORMAL, M7 MISSING	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE BELOW, M7 NORMAL	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE BELOW, M7 BELOW	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE ABOVE, M7 NORMAL	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE ABOVE, M7 MISSING	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE BELOW, M7 BELOW	2 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE ABOVE, M7 MISSING	1 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE BELOW, M7 NORMAL	2 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE NORMAL, M7 MISSING	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE NORMAL, M7 ABOVE	5 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE ABOVE, M7 ABOVE	3 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE NORMAL, M7 BELOW	4 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE NORMAL, M7 NORMAL	209 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE ABOVE, M7 NORMAL	7 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	ALT, PRE BELOW, M7 ABOVE	0 Participants

Secondary

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Time frame: At Month 7 (M7)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE NORMAL, M7 NORMAL	201 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE NORMAL, M7 BELOW	3 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE NORMAL, M7 ABOVE	6 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE NORMAL, M7 MISSING	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE BELOW, M7 NORMAL	4 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE BELOW, M7 BELOW	2 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE ABOVE, M7 NORMAL	5 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE ABOVE, M7 ABOVE	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE NORMAL, M7 ABOVE	7 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE NORMAL, M7 MISSING	2 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE BELOW, M7 NORMAL	3 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE BELOW, M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE ABOVE, M7 ABOVE	2 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE ABOVE, M7 NORMAL	7 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE NORMAL, M7 NORMAL	202 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE NORMAL, M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE ABOVE, M7 NORMAL	8 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE ABOVE, M7 ABOVE	5 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE NORMAL, M7 NORMAL	192 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE NORMAL, M7 MISSING	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE BELOW, M7 BELOW	2 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE ABOVE, M7 BELOW	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE NORMAL, M7 BELOW	3 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE BELOW, M7 NORMAL	3 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE NORMAL, M7 ABOVE	5 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE BELOW, M7 NORMAL	1 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE ABOVE, M7 NORMAL	5 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE BELOW, M7 BELOW	2 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE ABOVE, M7 ABOVE	4 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE BELOW, M7 ABOVE	2 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE NORMAL, M7 BELOW	1 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE NORMAL, M7 ABOVE	7 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE NORMAL, M7 MISSING	3 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE NORMAL, M7 NORMAL	202 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	LYM, PRE ABOVE, M7 BELOW	0 Participants

Secondary

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Time frame: At Month 7 (M7)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE BELOW, M7 BELOW	2 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE NORMAL, M7 MISSING	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE ABOVE, M7 ABOVE	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE BELOW, M7 NORMAL	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE NORMAL, M7 BELOW	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE NORMAL, M7 NORMAL	212 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE ABOVE], M7 BELOW	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE ABOVE, M7 NORMAL	5 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE NORMAL, M7 ABOVE	4 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE ABOVE, M7 MISSING	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE NORMAL, M7 BELOW	1 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE NORMAL, M7 NORMAL	202 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE NORMAL, M7 ABOVE	6 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE NORMAL, M7 MISSING	2 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE ABOVE], M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE BELOW, M7 NORMAL	1 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE BELOW, M7 BELOW	1 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE ABOVE, M7 NORMAL	6 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE ABOVE, M7 ABOVE	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE ABOVE, M7 MISSING	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE NORMAL, M7 BELOW	2 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE ABOVE], M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE BELOW, M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE NORMAL, M7 ABOVE	9 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE ABOVE, M7 MISSING	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE NORMAL, M7 NORMAL	197 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE NORMAL, M7 MISSING	3 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE ABOVE, M7 ABOVE	5 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE BELOW, M7 NORMAL	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE ABOVE, M7 NORMAL	6 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE NORMAL, M7 ABOVE	6 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE BELOW, M7 BELOW	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE NORMAL, M7 BELOW	2 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE ABOVE, M7 MISSING	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE ABOVE, M7 NORMAL	4 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE ABOVE], M7 BELOW	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE NORMAL, M7 NORMAL	208 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE NORMAL, M7 MISSING	3 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE BELOW, M7 NORMAL	2 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	MON, PRE ABOVE, M7 ABOVE	2 Participants

Secondary

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Time frame: At Month 7 (M7)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE NORMAL, M7 NORMAL	184 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE NORMAL, M7 MISSING	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE ABOVE, M7 NORMAL	6 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE NORMAL, M7 BELOW	16 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE BELOW, M7 NORMAL	8 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE NORMAL, M7 ABOVE	5 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE BELOW, M7 MISSING	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE ABOVE, M7 ABOVE	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE BELOW, M7 BELOW	2 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE BELOW, M7 BELOW	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE ABOVE, M7 NORMAL	5 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE NORMAL, M7 ABOVE	1 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE BELOW, M7 MISSING	1 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE NORMAL, M7 MISSING	2 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE ABOVE, M7 ABOVE	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE BELOW, M7 NORMAL	6 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE NORMAL, M7 BELOW	16 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE NORMAL, M7 NORMAL	188 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE ABOVE, M7 ABOVE	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE NORMAL, M7 NORMAL	185 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE NORMAL, M7 BELOW	9 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE NORMAL, M7 ABOVE	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE NORMAL, M7 MISSING	7 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE BELOW, M7 NORMAL	9 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE BELOW, M7 BELOW	7 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE ABOVE, M7 NORMAL	5 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE BELOW, M7 MISSING	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE BELOW, M7 BELOW	3 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE BELOW, M7 MISSING	1 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE ABOVE, M7 BELOW	2 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE BELOW, M7 NORMAL	15 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE NORMAL, M7 MISSING	6 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE NORMAL, M7 ABOVE	3 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE ABOVE, M7 ABOVE	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE NORMAL, M7 BELOW	9 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE NORMAL, M7 NORMAL	186 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE ABOVE, M7 NORMAL	1 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	NEU, PRE BELOW, M7 ABOVE	0 Participants

Secondary

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Time frame: At Month 7 (M7)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE NORMAL, M7 MISSING	1 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE NORMAL, M7 BELOW	7 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE ABOVE, M7 ABOVE	4 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE NORMAL, M7 ABOVE	2 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE BELOW, M7 BELOW	2 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE NORMAL, M7 NORMAL	204 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE ABOVE, M7 NORMAL	5 Participants
Cervarix 1/Placebo Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE BELOW, M7 NORMAL	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE NORMAL, M7 MISSING	1 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE ABOVE, M7 ABOVE	3 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE NORMAL, M7 NORMAL	204 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE NORMAL, M7 BELOW	7 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE NORMAL, M7 ABOVE	3 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE BELOW, M7 NORMAL	3 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE BELOW, M7 BELOW	3 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE ABOVE, M7 NORMAL	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE ABOVE, M7 BELOW	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE ABOVE, M7 ABOVE	6 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE BELOW, M7 NORMAL	2 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE NORMAL, M7 MISSING	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE NORMAL, M7 BELOW	2 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE NORMAL, M7 NORMAL	196 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE NORMAL, M7 ABOVE	2 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE ABOVE, M7 NORMAL	6 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE BELOW, M7 BELOW	10 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE NORMAL, M7 NORMAL	213 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE NORMAL, M7 MISSING	2 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE BELOW, M7 NORMAL	1 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE ABOVE, M7 ABOVE	1 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE BELOW, M7 BELOW	3 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE ABOVE, M7 NORMAL	3 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE NORMAL, M7 BELOW	7 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE BELOW, M7 ABOVE	0 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE NORMAL, M7 ABOVE	3 Participants
Cervarix 2 Group	Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.	RBC, PRE ABOVE, M7 BELOW	0 Participants

Secondary

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).

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

Time frame: Within 30 days (Day 0-29) after vaccination.

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 (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).	Related unsolicited AE(s)	26 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).	Grade 3 unsolicited AE(s)	11 Participants
Cervarix 1/Placebo Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).	Any unsolicited AE(s)	83 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).	Related unsolicited AE(s)	20 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).	Grade 3 unsolicited AE(s)	8 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).	Any unsolicited AE(s)	85 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).	Any unsolicited AE(s)	76 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).	Grade 3 unsolicited AE(s)	6 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).	Related unsolicited AE(s)	16 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).	Related unsolicited AE(s)	27 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).	Grade 3 unsolicited AE(s)	14 Participants
Cervarix 2 Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).	Any unsolicited AE(s)	107 Participants

Secondary

Number of Subjects With Medically Significant Conditions (MSCs).

MSCs were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. The following did not require reporting as long as they were not considered SAEs and occurred more than 30 days after each vaccination: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities, injury, visits for routine physical examination or visits for vaccination.

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

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With Medically Significant Conditions (MSCs).	85 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Medically Significant Conditions (MSCs).	97 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Medically Significant Conditions (MSCs).	92 Participants
Cervarix 2 Group	Number of Subjects With Medically Significant Conditions (MSCs).	89 Participants

Secondary

Number of Subjects With Medically Significant Conditions (MSCs).

Time frame: From Month 0 to Month 7.

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With Medically Significant Conditions (MSCs).	40 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Medically Significant Conditions (MSCs).	48 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Medically Significant Conditions (MSCs).	45 Participants
Cervarix 2 Group	Number of Subjects With Medically Significant Conditions (MSCs).	42 Participants

Secondary

Number of Subjects With Medically Significant Conditions (MSCs).

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	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With Medically Significant Conditions (MSCs).	79 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Medically Significant Conditions (MSCs).	94 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Medically Significant Conditions (MSCs).	88 Participants
Cervarix 2 Group	Number of Subjects With Medically Significant Conditions (MSCs).	82 Participants

Secondary

Number of Subjects With New Onset of Autoimmune Diseases (NOADs)

NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

Time frame: From Month 0 to Month 7.

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With New Onset of Autoimmune Diseases (NOADs)	1 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With New Onset of Autoimmune Diseases (NOADs)	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With New Onset of Autoimmune Diseases (NOADs)	2 Participants
Cervarix 2 Group	Number of Subjects With New Onset of Autoimmune Diseases (NOADs)	1 Participants

Secondary

Number of Subjects With New Onset of Autoimmune Diseases (NOADs)

NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

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

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With New Onset of Autoimmune Diseases (NOADs)	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With New Onset of Autoimmune Diseases (NOADs)	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With New Onset of Autoimmune Diseases (NOADs)	5 Participants
Cervarix 2 Group	Number of Subjects With New Onset of Autoimmune Diseases (NOADs)	6 Participants

Secondary

Number of Subjects With New Onset of Autoimune Diseases (NOADs)

NOADs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

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	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With New Onset of Autoimune Diseases (NOADs)	3 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With New Onset of Autoimune Diseases (NOADs)	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With New Onset of Autoimune Diseases (NOADs)	5 Participants
Cervarix 2 Group	Number of Subjects With New Onset of Autoimune Diseases (NOADs)	4 Participants

Secondary

Number of Subjects With New Onset of Chronic Diseases (NOCDs)

NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

Time frame: From Month 0 to Month 7.

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With New Onset of Chronic Diseases (NOCDs)	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With New Onset of Chronic Diseases (NOCDs)	2 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With New Onset of Chronic Diseases (NOCDs)	6 Participants
Cervarix 2 Group	Number of Subjects With New Onset of Chronic Diseases (NOCDs)	3 Participants

Secondary

Number of Subjects With New Onset of Chronic Diseases (NOCDs)

NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

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	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With New Onset of Chronic Diseases (NOCDs)	8 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With New Onset of Chronic Diseases (NOCDs)	11 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With New Onset of Chronic Diseases (NOCDs)	13 Participants
Cervarix 2 Group	Number of Subjects With New Onset of Chronic Diseases (NOCDs)	6 Participants

Secondary

Number of Subjects With New Onset of Chronic Diseases (NOCDs)

NOCDs include conditions such as autoimmune disorders, asthma, type I diabetes, or allergies.

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

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With New Onset of Chronic Diseases (NOCDs)	8 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With New Onset of Chronic Diseases (NOCDs)	11 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With New Onset of Chronic Diseases (NOCDs)	14 Participants
Cervarix 2 Group	Number of Subjects With New Onset of Chronic Diseases (NOCDs)	7 Participants

Secondary

Number of Subjects With Pregnancy Outcomes.

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.

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With Pregnancy Outcomes.	Lost to follow up	1 Participants
Cervarix 1/Placebo Group	Number of Subjects With Pregnancy Outcomes.	Live infant NO apparent congenital anomaly	22 Participants
Cervarix 1/Placebo Group	Number of Subjects With Pregnancy Outcomes.	Elective termination congenital anomaly	0 Participants
Cervarix 1/Placebo Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion NO apparent congenital anom.	2 Participants
Cervarix 1/Placebo Group	Number of Subjects With Pregnancy Outcomes.	Molar pregnancy	1 Participants
Cervarix 1/Placebo Group	Number of Subjects With Pregnancy Outcomes.	Elective termination NO apparent congenital anom.	5 Participants
Cervarix 1/Placebo Group	Number of Subjects With Pregnancy Outcomes.	Ectopic pregnancy	1 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Live infant NO apparent congenital anomaly	16 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Ectopic pregnancy	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination NO apparent congenital anom.	6 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination congenital anomaly	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Lost to follow up	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Molar pregnancy	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion NO apparent congenital anom.	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination NO apparent congenital anom.	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Live infant NO apparent congenital anomaly	22 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Lost to follow up	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion NO apparent congenital anom.	3 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Molar pregnancy	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Ectopic pregnancy	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination congenital anomaly	1 Participants
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination congenital anomaly	0 Participants
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination NO apparent congenital anom.	6 Participants
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Live infant NO apparent congenital anomaly	18 Participants
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion NO apparent congenital anom.	1 Participants
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Molar pregnancy	0 Participants
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Lost to follow up	0 Participants
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Ectopic pregnancy	1 Participants

Secondary

Number of Subjects With Pregnancy Outcomes.

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With Pregnancy Outcomes.	Ectopic pregnancy	1 Participants
Cervarix 1/Placebo Group	Number of Subjects With Pregnancy Outcomes.	Pregnancy ongoing	0 Participants
Cervarix 1/Placebo Group	Number of Subjects With Pregnancy Outcomes.	Lost to follow up	1 Participants
Cervarix 1/Placebo Group	Number of Subjects With Pregnancy Outcomes.	Elective termination with NO ACA	5 Participants
Cervarix 1/Placebo Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion with NO ACA	1 Participants
Cervarix 1/Placebo Group	Number of Subjects With Pregnancy Outcomes.	Elective termination with CA	0 Participants
Cervarix 1/Placebo Group	Number of Subjects With Pregnancy Outcomes.	Live infant with NO ACA	15 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Pregnancy ongoing	1 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Live infant with NO ACA	12 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination with CA	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Lost to follow up	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion with NO ACA	0 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination with NO ACA	3 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Pregnancy Outcomes.	Ectopic pregnancy	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Live infant with NO ACA	15 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Ectopic pregnancy	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination with NO ACA	3 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination with CA	1 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Lost to follow up	0 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Pregnancy ongoing	2 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion with NO ACA	3 Participants
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination with CA	0 Participants
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Spontaneous abortion with NO ACA	1 Participants
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Pregnancy ongoing	2 Participants
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Elective termination with NO ACA	5 Participants
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Ectopic pregnancy	0 Participants
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Lost to follow up	0 Participants
Cervarix 2 Group	Number of Subjects With Pregnancy Outcomes.	Live infant with NO ACA	12 Participants

Secondary

Number of Subjects With 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.

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

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With Serious Adverse Events (SAEs)	14 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Serious Adverse Events (SAEs)	16 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Serious Adverse Events (SAEs)	19 Participants
Cervarix 2 Group	Number of Subjects With Serious Adverse Events (SAEs)	15 Participants

Secondary

Number of Subjects With Serious Adverse Events (SAEs).

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	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With Serious Adverse Events (SAEs).	10 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Serious Adverse Events (SAEs).	13 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Serious Adverse Events (SAEs).	19 Participants
Cervarix 2 Group	Number of Subjects With Serious Adverse Events (SAEs).	13 Participants

Secondary

Number of Subjects With 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.

Time frame: From Month 0 to Month 7.

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cervarix 1/Placebo Group	Number of Subjects With Serious Adverse Events (SAEs).	4 Participants
Cervarix 1/Placebo/Cervarix 1 Group	Number of Subjects With Serious Adverse Events (SAEs).	4 Participants
Cervarix 2/Placebo/Cervarix 2 Group	Number of Subjects With Serious Adverse Events (SAEs).	4 Participants
Cervarix 2 Group	Number of Subjects With Serious Adverse Events (SAEs).	2 Participants

Secondary

Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies

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.

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	20-25 years, Anti-HPV-18	4389.6 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	9-14 years, Anti-HPV-18	8085.8 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	9-14 years, Anti-HPV-16	15028.4 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	20-25 years, Anti-HPV-16	7331.4 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	15-19 years, Anti-HPV-16	10818.7 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	15-19 years, Anti-HPV-18	6170.1 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	15-19 years, Anti-HPV-16	7869.6 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	20-25 years, Anti-HPV-16	5209.2 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	9-14 years, Anti-HPV-18	5630.7 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	20-25 years, Anti-HPV-18	3889.2 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	15-19 years, Anti-HPV-18	5039.3 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	9-14 years, Anti-HPV-16	11058.6 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	15-19 years, Anti-HPV-18	4907.0 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	20-25 years, Anti-HPV-18	3576.8 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	15-19 years, Anti-HPV-16	12817.4 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	9-14 years, Anti-HPV-18	7192.9 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	9-14 years, Anti-HPV-16	22066.3 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	20-25 years, Anti-HPV-16	7370.0 EL.U/mL

Secondary

Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies

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

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18	5997.5 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16	11784.8 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18	4811.4 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16	8726.1 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16	15179.2 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18	5087.1 EL.U/mL

Secondary

Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies

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).

Time frame: At Month 60 of the safety follow-up phase

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 60	1254.0 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 60	622.2 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 60	976.1 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 60	557.9 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 60	745.3 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 60	1858.5 EL.U/mL

Secondary

Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies

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

Time frame: 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.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 24	1756.4 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 36	712.8 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 36	1462.2 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 48	1261.2 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 12	1760.1 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 18	1025.2 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 48	626.3 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 24	818.2 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 12	3256.0 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 18	2229.4 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 24	674.6 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 18	883.1 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 48	517.0 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 12	2438.7 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 36	1094.0 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 12	1426.2 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 36	617.9 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 18	1659.1 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 48	953.5 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 24	1285.1 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 48	1892.3 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 24	866.8 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 12	1714.5 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 48	723.2 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 18	1096.6 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 18	3185.1 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 24	2425.9 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 36	2195.4 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-16 at Month 12	4726.7 EL.U/mL
Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies	Anti-HPV-18 at Month 36	874.2 EL.U/mL

Secondary

Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .

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.

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

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo Group	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
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .	Anti-HPV-16	397.9 EL.U/mL
Cervarix 1/Placebo/Cervarix 1 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .	Anti-HPV-18	228.3 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .	Anti-HPV-16	266.4 EL.U/mL
Cervarix 2/Placebo/Cervarix 2 Group	Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .	Anti-HPV-18	181.9 EL.U/mL

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026

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

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Related papers

Interventions

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Study design

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Exclusion criteria

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Secondary

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Participant flow

Recruitment details

Pre-assignment details

Participants by arm

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Baseline characteristics

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Outcome results

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms

Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies

Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)

Number of Seroconverted Subjects Against Human Papillomavirus 16 (HPV-16) and Human Papillomavirus 18 (HPV-18)

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed.

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).

Number of Subjects With Medically Significant Conditions (MSCs).

Number of Subjects With Medically Significant Conditions (MSCs).

Number of Subjects With Medically Significant Conditions (MSCs).

Number of Subjects With New Onset of Autoimmune Diseases (NOADs)

Number of Subjects With New Onset of Autoimmune Diseases (NOADs)

Number of Subjects With New Onset of Autoimune Diseases (NOADs)

Number of Subjects With New Onset of Chronic Diseases (NOCDs)

Number of Subjects With New Onset of Chronic Diseases (NOCDs)

Number of Subjects With New Onset of Chronic Diseases (NOCDs)

Number of Subjects With Pregnancy Outcomes.

Number of Subjects With Pregnancy Outcomes.

Number of Subjects With Serious Adverse Events (SAEs)

Number of Subjects With Serious Adverse Events (SAEs).

Number of Subjects With Serious Adverse Events (SAEs).

Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies

Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies

Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies

Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies

Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies .