Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18

Phase 3, Open, Age-stratified Study to Assess Immunogenicity and Safety of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to 3-dose Schedule (0,1,6 Months) in Healthy Female Subjects Aged 15 - 55 Years and Long Term Follow-up

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00196937

Enrollment

667

Registered

2005-09-20

Start date

2004-10-07

Completion date

2005-12-15

Last updated

2019-12-11

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

Conditions

Infections, Papillomavirus

Keywords

HPV Vaccine Safety

Brief summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine over 12 months, in women up to 55 years of age at study start. Approximately 660 study subjects will receive the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule. The study will be extended to assess long-term safety and immunogenicity of the HPV-16/18 vaccine.

Interventions

BIOLOGICALCervarix

Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

for primary study: * A woman who the investigator believes that she and/or her parents/legally acceptable representative can and will comply with the requirements of the protocol. * A woman between, and including, 15 and 55 years of age at the time of the first vaccination. * Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative and, in addition, the subject should sign and personally date a written informed assent). * Free of obvious health problems. * Subject must have a negative urine pregnancy test. * Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using adequate contraceptive precautions for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore become of childbearing potential must agree to follow the same precautions Inclusion criteria for extension studies * A female who enrolled in the primary study and received three doses of vaccine. * Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative and, in addition, the subject must sign and personally date a written informed assent).

Exclusion criteria

for primary study: * Pregnant or breastfeeding. * A woman planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12). * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose, or planned administration during the study period. * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of study 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. * Previous administration of components of the investigational vaccine * Previous vaccination against HPV. * Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination. * History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine. * Hypersensitivity to latex. * Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. * History of chronic condition(s) requiring treatment. * Administration of immunoglobulins and/or any blood product within 3 months preceding the first dose of study vaccine or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window. * Acute disease at the time of enrolment.

Design outcomes

Primary

Measure	Time frame	Description
Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age	At Month 7	Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies \[i.e. antibody titer greater than or equal to (≥) the cut-off value\] in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Data for the Cervarix (46-55 Years) Group are presented in the Secondary Outcomes as per Protocol.
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	At Months 18, 24, 36 and 48	Anti-HPV 16/18 antibody titers were detected in sera samples and presented as Geometric Mean Titers (GMT), expressed in EL.U/mL. Data for pre-vaccination, Month 2, Month 7 and Month 12 are presented in the Secondary Outcomes as per Protocol.

Secondary

Measure	Time frame	Description
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12	At Month 2 and Month 12	Seroconversion was defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Seroconversion results at Month 7 are presented in the Primary Outcome Measure 1 for Cervarix (15-25 Years) Group and Cervarix (26-45 Years) Group and in the Secondary Outcome Measure 3 for the Cervarix (46-55 Years) Group.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses	Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms	During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimetres (mm) of injection site.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	During the 30-day (from the day of vaccination up to 29 subsequent days) post-vaccination period	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Number of Subjects Reporting Serious Adverse Events (SAE)	During the entire study period (from Day 0 up to Month 48)	An SAE is any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above.
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies, in Women 46 - 55 Years of Age	At Month 7	Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Seroconversion results at Month 7 for the Cervarix (15-25 Years) Group and for the Cervarix (26-45 Years) Group are presented in the Primary Outcome Measure 1.
Number of Subjects Reporting Medically Significant Conditions	During the entire study period (from Day 0 up to Month 48)	Medically significant conditions are AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or SAEs that were not related to common diseases.
Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples	At Months 18 and 24	Anti-HPV 16/18 antibody titers were detected in CVS samples and presented as GMTs, expressed in EL.U/mL based on ELISA.
Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects	At Months 18 and 24	Seropositivity was defined as total IgG ≥ 0 microgram per milliliter (µg/mL) and was detected in sera and in CVS samples by ELISA.
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	During the entire study period (from Day 0 up to Month 48)	Outcomes of pregnancies were: Abnormal infant / Congenital anomaly, Elective termination, Missed abortion, Normal infant, Premature birth, Spontaneous abortion / Miscarriage and Outcome unknown.
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	During the entire study period (from Day 0 up to Month 48)	NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases.
Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	At PRE and Months 2, 7 and 12	Anti-HPV 16/18 antibody titers were detected in sera samples and presented as GMT, expressed in EL.U/mL. Data for Months 18, 24, 36 and 48 are presented in the Primary Outcome Measure 2 as per Protocol.

Countries

Germany, Poland

Participant flow

Pre-assignment details

Out of the 667 enrolled subjects, 1 subject was excluded for not receiving vaccination and the actual starting number was 666.

Participants by arm

Arm	Count
Cervarix (15-25 Years) Group Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.	229
Cervarix (26-45 Years) Group Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.	226
Cervarix (46-55 Years) Group Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.	211
Total	666

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	4	3	3
Overall Study	Non-serious adverse event	1	1	1
Overall Study	Other	3	1	1
Overall Study	Serious Adverse Event	1	0	0
Overall Study	Withdrawal by Subject	0	0	2

Baseline characteristics

Characteristic	Cervarix (15-25 Years) Group	Cervarix (26-45 Years) Group	Cervarix (46-55 Years) Group	Total
Age, Continuous	20.9 years STANDARD_DEVIATION 2.67	35.5 years STANDARD_DEVIATION 6.02	49.6 years STANDARD_DEVIATION 2.8	34.9 years STANDARD_DEVIATION 12.38
Race/Ethnicity, Customized Black	0 Participants	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized White/Caucasian	229 Participants	225 Participants	211 Participants	665 Participants
Sex: Female, Male Female	229 Participants	226 Participants	211 Participants	666 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 229	0 / 226	2 / 211
other Total, other adverse events	224 / 229	216 / 226	182 / 211
serious Total, serious adverse events	6 / 229	8 / 226	11 / 211

Outcome results

Primary

Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48

Anti-HPV 16/18 antibody titers were detected in sera samples and presented as Geometric Mean Titers (GMT), expressed in EL.U/mL. Data for pre-vaccination, Month 2, Month 7 and Month 12 are presented in the Secondary Outcomes as per Protocol.

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

Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-16 (Month 18)	2197.9 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-16 (Month 24)	1730.7 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-16 (Month 36)	1491.5 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-16 (Month 48)	1382.7 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-18 (Month 18)	816.0 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-18 (Month 24)	673.6 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-18 (Month 36)	539.9 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-18 (Month 48)	475.5 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-16 (Month 36)	607.2 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-18 (Month 36)	220.1 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-16 (Month 48)	524.2 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-18 (Month 18)	328.4 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-18 (Month 24)	280.8 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-16 (Month 18)	933.3 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-16 (Month 24)	733.0 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-18 (Month 48)	189.0 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-16 (Month 36)	363.9 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-16 (Month 24)	472.9 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-16 (Month 18)	578.5 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-16 (Month 48)	324.0 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-18 (Month 36)	136.9 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-18 (Month 24)	185.7 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-18 (Month 18)	247.9 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48	Anti-HPV-18 (Month 48)	122.9 EL.U/mL

Primary

Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age

Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies \[i.e. antibody titer greater than or equal to (≥) the cut-off value\] in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Data for the Cervarix (46-55 Years) Group are presented in the Secondary Outcomes as per Protocol.

Time frame: At Month 7

Population: The analysis was based the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the time of the analysis and who were seronegative before vaccination.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix (15-25 Years) Group	Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age	Anti-HPV-16	191 Participants
Cervarix (15-25 Years) Group	Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age	Anti-HPV-18	202 Participants
Cervarix (26-45 Years) Group	Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age	Anti-HPV-16	164 Participants
Cervarix (26-45 Years) Group	Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age	Anti-HPV-18	185 Participants

Comparison: Immune response to anti-HPV-16 in terms of SCR: To evaluate if the immunogenicity (as determined by ELISA) of the Cervarix vaccine, one month after the third dose (Month 7), in young women 26 - 45 years of age is non-inferior to that in women 15 - 25 years of age.95% CI: [-1.97, 2.29]

Comparison: Immune response to anti-HPV-18 in terms of SCR: To evaluate if the immunogenicity (as determined by ELISA) of the Cervarix vaccine, one month after the third dose (Month 7), in young women 26 - 45 years of age is non-inferior to that in women 15 - 25 years of age.95% CI: [-1.87, 2.03]

Secondary

Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12

Anti-HPV 16/18 antibody titers were detected in sera samples and presented as GMT, expressed in EL.U/mL. Data for Months 18, 24, 36 and 48 are presented in the Primary Outcome Measure 2 as per Protocol.

Time frame: At PRE and Months 2, 7 and 12

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-16 (PRE)	4.0 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-16 (Month 2)	3090.0 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-16 (Month 7)	7908.4 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-16 (Month 12)	3055.3 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-18 (PRE)	3.5 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-18 (Month 2)	2229.0 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-18 (Month 7)	3499.3 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-18 (Month 12)	1284.6 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-16 (Month 7)	4029.2 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-18 (Month 7)	1837.3 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-16 (Month 12)	1563.7 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-18 (PRE)	3.5 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-18 (Month 2)	1390.3 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-16 (PRE)	4.0 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-16 (Month 2)	1824.6 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-18 (Month 12)	619.8 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-16 (Month 7)	2566.8 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-16 (Month 2)	1269.9 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-16 (PRE)	4.0 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-16 (Month 12)	926.2 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-18 (Month 7)	1313.0 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-18 (Month 2)	957.2 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-18 (PRE)	3.5 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12	Anti-HPV-18 (Month 12)	430.2 EL.U/mL

Secondary

Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples

Anti-HPV 16/18 antibody titers were detected in CVS samples and presented as GMTs, expressed in EL.U/mL based on ELISA.

Time frame: At Months 18 and 24

Population: The analysis was based on a subset of subjects from the TVC for whom CVS samples were available and who received at least one dose of vaccine in this study.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples	Anti-HPV-16 (Month 24)	59.2 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples	Anti-HPV-18 (Month 18)	28.4 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples	Anti-HPV-16 (Month 18)	63.6 EL.U/mL
Cervarix (15-25 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples	Anti-HPV-18 (Month 24)	23.3 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples	Anti-HPV-16 (Month 24)	52.7 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples	Anti-HPV-16 (Month 18)	50.7 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples	Anti-HPV-18 (Month 18)	38.5 EL.U/mL
Cervarix (26-45 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples	Anti-HPV-18 (Month 24)	32.4 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples	Anti-HPV-18 (Month 18)	21.2 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples	Anti-HPV-16 (Month 18)	56.1 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples	Anti-HPV-16 (Month 24)	68.8 EL.U/mL
Cervarix (46-55 Years) Group	Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples	Anti-HPV-18 (Month 24)	31.2 EL.U/mL

Secondary

Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies, in Women 46 - 55 Years of Age

Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Seroconversion results at Month 7 for the Cervarix (15-25 Years) Group and for the Cervarix (26-45 Years) Group are presented in the Primary Outcome Measure 1.

Time frame: At Month 7

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix (15-25 Years) Group	Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies, in Women 46 - 55 Years of Age	Anti-HPV-16	136 Participants
Cervarix (15-25 Years) Group	Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies, in Women 46 - 55 Years of Age	Anti-HPV-18	172 Participants

Secondary

Number of Subjects Reporting Medically Significant Conditions

Medically significant conditions are AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or SAEs that were not related to common diseases.

Time frame: During the entire study period (from Day 0 up to Month 48)

Population: The analysis was based on the TVC (data up to Month 7), which included all subjects with at least one study vaccine administered and on the EFU Vaccinated cohort (data from Month 7 to Month 48) which included subjects who received 3 doses of vaccine in the primary phase of the study and for whom data were available.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix (15-25 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Day 30 to Month 7	8 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Month 18 to Month 24	3 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Month 12 to Month 18	3 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Day 0 to Day 29	12 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Month 36 to Month 48	1 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Month 24 to Month 36	5 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Month 7 to Month 12	1 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Month 12 to Month 18	5 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Day 0 to Day 29	12 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Day 30 to Month 7	8 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Month 7 to Month 12	3 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Month 18 to Month 24	3 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Month 24 to Month 36	4 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Month 36 to Month 48	7 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Month 18 to Month 24	2 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Day 30 to Month 7	10 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Month 36 to Month 48	4 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Month 24 to Month 36	6 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Month 12 to Month 18	6 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Month 7 to Month 12	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Medically Significant Conditions	Day 0 to Day 29	11 Participants

Secondary

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

NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases.

Time frame: During the entire study period (from Day 0 up to Month 48)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix (15-25 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Month 24 to Month 36	2 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Month 36 to Month 48	1 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Month 18 to Month 24	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Month 12 to Month 18	1 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Day 0 to Month 7	3 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Month 7 to Month 12	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Day 0 to Month 7	1 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Month 24 to Month 36	2 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Month 7 to Month 12	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Month 18 to Month 24	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Month 36 to Month 48	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Month 12 to Month 18	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Month 36 to Month 48	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Day 0 to Month 7	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Month 7 to Month 12	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Month 12 to Month 18	2 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Month 18 to Month 24	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)	Month 24 to Month 36	1 Participants

Secondary

Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies

Outcomes of pregnancies were: Abnormal infant / Congenital anomaly, Elective termination, Missed abortion, Normal infant, Premature birth, Spontaneous abortion / Miscarriage and Outcome unknown.

Time frame: During the entire study period (from Day 0 up to Month 48)

Population: The analysis was based on the TVC, which included all subjects with at least one vaccine administration documented and for whom data were available.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix (15-25 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Elective termination	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Premature birth	1 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Normal infant	19 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Abnormal infant / Congenital anomaly	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Outcome unknown	1 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Spontaneous abortion / Miscarriage	1 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Missed abortion	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Normal infant	21 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Abnormal infant / Congenital anomaly	1 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Elective termination	1 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Missed abortion	2 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Premature birth	1 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Spontaneous abortion / Miscarriage	4 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Outcome unknown	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Premature birth	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Elective termination	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Outcome unknown	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Spontaneous abortion / Miscarriage	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Normal infant	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Missed abortion	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies	Abnormal infant / Congenital anomaly	0 Participants

Secondary

Number of Subjects Reporting Serious Adverse Events (SAE)

An SAE is any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above.

Time frame: During the entire study period (from Day 0 up to Month 48)

Population: The analysis was based on the TVC (up to Month 7), which included all subjects with at least one study vaccine administered and on the Extended Follow-up (EFU) Vaccinated cohort (Month 7 to Month 48) which included subjects who received 3 doses of vaccine in the primary phase of the study and for whom data were available.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix (15-25 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Day 0 to Month 7	3 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Month 7 to Month 12	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Month 12 to Month 18	1 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Month 18 to Month 24	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Month 24 to Month 36	3 Participants
Cervarix (15-25 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Month 36 to Month 48	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Month 36 to Month 48	5 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Day 0 to Month 7	1 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Month 18 to Month 24	1 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Month 24 to Month 36	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Month 7 to Month 12	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Month 12 to Month 18	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Month 7 to Month 12	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Month 12 to Month 18	4 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Month 36 to Month 48	5 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Month 18 to Month 24	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Day 0 to Month 7	2 Participants
Cervarix (46-55 Years) Group	Number of Subjects Reporting Serious Adverse Events (SAE)	Month 24 to Month 36	1 Participants

Secondary

Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12

Seroconversion was defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Seroconversion results at Month 7 are presented in the Primary Outcome Measure 1 for Cervarix (15-25 Years) Group and Cervarix (26-45 Years) Group and in the Secondary Outcome Measure 3 for the Cervarix (46-55 Years) Group.

Time frame: At Month 2 and Month 12

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix (15-25 Years) Group	Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12	Anti-HPV-16 (Month 2)	195 Participants
Cervarix (15-25 Years) Group	Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12	Anti-HPV-16 (Month 12)	183 Participants
Cervarix (15-25 Years) Group	Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12	Anti-HPV-18 (Month 2)	207 Participants
Cervarix (15-25 Years) Group	Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12	Anti-HPV-18 (Month 12)	192 Participants
Cervarix (26-45 Years) Group	Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12	Anti-HPV-18 (Month 12)	182 Participants
Cervarix (26-45 Years) Group	Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12	Anti-HPV-16 (Month 2)	164 Participants
Cervarix (26-45 Years) Group	Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12	Anti-HPV-18 (Month 2)	186 Participants
Cervarix (26-45 Years) Group	Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12	Anti-HPV-16 (Month 12)	163 Participants
Cervarix (46-55 Years) Group	Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12	Anti-HPV-18 (Month 12)	169 Participants
Cervarix (46-55 Years) Group	Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12	Anti-HPV-16 (Month 12)	134 Participants
Cervarix (46-55 Years) Group	Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12	Anti-HPV-18 (Month 2)	175 Participants
Cervarix (46-55 Years) Group	Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12	Anti-HPV-16 (Month 2)	139 Participants

Secondary

Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects

Seropositivity was defined as total IgG ≥ 0 microgram per milliliter (µg/mL) and was detected in sera and in CVS samples by ELISA.

Time frame: At Months 18 and 24

Population: The analysis was based on a subset of subjects from the TVC for whom CVS samples were available and who received at least one dose of vaccine in this study.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix (15-25 Years) Group	Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects	IgG serum (Month 18)	44 Participants
Cervarix (15-25 Years) Group	Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects	IgG serum (Month 24)	59 Participants
Cervarix (15-25 Years) Group	Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects	IgG secretion (Month 18)	39 Participants
Cervarix (15-25 Years) Group	Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects	IgG secretion (Month 24)	57 Participants
Cervarix (26-45 Years) Group	Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects	IgG secretion (Month 24)	50 Participants
Cervarix (26-45 Years) Group	Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects	IgG serum (Month 18)	51 Participants
Cervarix (26-45 Years) Group	Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects	IgG secretion (Month 18)	47 Participants
Cervarix (26-45 Years) Group	Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects	IgG serum (Month 24)	51 Participants
Cervarix (46-55 Years) Group	Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects	IgG secretion (Month 24)	41 Participants
Cervarix (46-55 Years) Group	Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects	IgG serum (Month 24)	41 Participants
Cervarix (46-55 Years) Group	Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects	IgG secretion (Month 18)	39 Participants
Cervarix (46-55 Years) Group	Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects	IgG serum (Month 18)	51 Participants

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimetres (mm) of injection site.

Time frame: During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses

Population: The analysis was based on the TVC, which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed and for whom data were available.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain - Dose 3	13 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain - Dose 2	186 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain - Dose 3	179 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain - Across doses	220 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain - Dose 1	6 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain - Dose 2	11 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain - Dose 1	197 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain - Across doses	23 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness - Dose 1	77 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness - Dose 2	70 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness - Dose 3	90 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness - Across doses	133 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness - Dose 1	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness - Dose 2	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness - Dose 3	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness - Across doses	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling - Dose 1	36 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling - Dose 2	49 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling - Dose 3	66 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling - Across doses	96 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling - Dose 1	1 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling - Dose 2	2 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling - Dose 3	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling - Across doses	3 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling - Dose 2	3 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain - Dose 1	182 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness - Dose 1	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling - Dose 1	52 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain - Dose 2	162 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness - Dose 3	85 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling - Dose 1	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain - Dose 3	172 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness - Dose 2	4 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling - Dose 3	1 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain - Across doses	210 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness - Dose 2	80 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling - Dose 2	61 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain - Dose 1	6 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness - Dose 3	3 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness - Across doses	126 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain - Dose 2	6 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness - Dose 1	80 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling - Across doses	3 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain - Dose 3	7 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness - Across doses	6 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling - Dose 3	70 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain - Across doses	15 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling - Across doses	100 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain - Across doses	9 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness - Dose 1	70 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness - Dose 2	60 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness - Dose 3	65 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling - Across doses	83 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Redness - Across doses	101 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling - Dose 3	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness - Dose 1	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness - Dose 2	2 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling - Dose 1	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness - Dose 3	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling - Across doses	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Redness - Across doses	2 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain - Dose 1	141 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain - Dose 2	120 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling - Dose 1	37 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain - Dose 3	124 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Swelling - Dose 2	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Pain - Across doses	171 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain - Dose 1	3 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling - Dose 2	47 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain - Dose 2	4 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Grade 3 Pain - Dose 3	3 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Any Swelling - Dose 3	60 Participants

Secondary

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

Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Time frame: During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses

Population: The analysis was based on the Total Vaccinated Cohort (TVC), which included all subjects with at least one study vaccine administered, on subjects with symptom sheets completed and for whom data were available.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever - Dose 1	10 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Arthralgia - Dose 2	17 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Arthralgia - Dose 3	22 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Arthralgia - Across doses	45 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Arthralgia - Dose 1	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Arthralgia - Dose 2	1 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Arthralgia - Dose 3	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Arthralgia - Across doses	1 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Arthralgia - Dose 1	14 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Arthralgia - Dose 2	11 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Arthralgia - Dose 3	14 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Arthralgia - Across doses	28 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fatigue - Dose 1	85 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fatigue - Dose 2	68 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fatigue - Dose 3	84 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fatigue - Across doses	128 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fatigue - Dose 1	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fatigue - Dose 2	3 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fatigue - Dose 3	2 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fatigue - Across doses	5 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fatigue - Dose 1	46 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fatigue - Dose 2	46 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fatigue - Dose 3	54 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fatigue - Across doses	86 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Arthralgia - Dose 1	21 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever - Dose 2	9 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever - Dose 3	5 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever - Across doses	128 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever - Dose 1	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever - Dose 2	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever - Dose 3	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever - Across doses	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever - Dose 1	7 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever - Dose 2	4 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever - Dose 3	2 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever - Across doses	11 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Gastrointestinal - Dose 1	34 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Gastrointestinal - Dose 2	25 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Gastrointestinal - Dose 3	16 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Gastrointestinal - Across doses	51 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Gastrointestinal - Dose 1	1 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Gastrointestinal - Dose 2	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Gastrointestinal - Dose 3	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Gastrointestinal - Across doses	1 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Gastrointestinal - Dose 1	22 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Gastrointestinal - Dose 2	15 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Gastrointestinal - Dose 3	11 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Gastrointestinal - Across doses	30 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Headache - Dose 1	77 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Headache - Dose 2	63 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Headache - Dose 3	64 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Headache - Across doses	123 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Headache - Dose 1	3 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Headache - Dose 2	5 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Headache - Dose 3	4 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Headache - Across doses	10 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Headache - Dose 1	42 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Headache - Dose 2	34 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Headache - Dose 3	40 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Headache - Across doses	77 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Myalgia - Dose 1	93 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Myalgia - Dose 2	69 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Myalgia - Dose 3	71 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Myalgia - Across doses	126 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Myalgia - Dose 1	1 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Myalgia - Dose 2	4 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Myalgia - Dose 3	4 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Rash - Dose 2	4 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Myalgia - Across doses	8 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Myalgia - Dose 1	71 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Myalgia - Dose 2	52 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Myalgia - Dose 3	58 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Myalgia - Across doses	96 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Rash - Dose 1	6 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Rash - Dose 3	10 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Rash - Across doses	16 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Rash - Dose 1	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Rash - Dose 2	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Rash - Dose 3	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Rash - Across doses	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Rash - Dose 1	5 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Rash - Dose 2	3 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Rash - Dose 3	9 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Rash - Across doses	13 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Urticaria - Dose 1	5 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Urticaria - Dose 2	2 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Urticaria - Dose 3	6 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Urticaria - Across doses	10 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Urticaria - Dose 1	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Urticaria - Dose 2	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Urticaria - Dose 3	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Urticaria - Across doses	0 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Urticaria - Dose 1	3 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Urticaria - Dose 2	2 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Urticaria - Dose 3	5 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Urticaria - Across doss	7 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Urticaria - Dose 2	3 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Arthralgia - Dose 1	15 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Rash - Dose 2	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Myalgia - Dose 1	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Arthralgia - Dose 2	22 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Headache - Dose 1	62 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Gastrointestinal - Dose 1	3 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Arthralgia - Dose 3	20 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Rash - Dose 1	6 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Headache - Dose 2	43 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Arthralgia - Across doses	43 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Gastrointestinal - Dose 1	18 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Myalgia - Dose 2	5 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Arthralgia - Dose 1	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever - Dose 3	2 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Headache - Dose 3	47 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Arthralgia - Dose 2	3 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Gastrointestinal - Dose 2	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Urticaria - Dose 3	1 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Arthralgia - Dose 3	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Headache - Across doses	100 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Myalgia - Dose 3	6 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Arthralgia - Across doses	3 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Rash - Dose 1	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Urticaria - Dose 3	2 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Arthralgia - Dose 1	7 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Rash - Dose 2	2 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Headache - Dose 1	3 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Arthralgia - Dose 2	9 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Urticaria - Across doss	4 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Gastrointestinal - Dose 3	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Arthralgia - Dose 3	11 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Headache - Dose 2	3 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Myalgia - Across doses	9 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Arthralgia - Across doses	23 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Gastrointestinal - Dose 2	11 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Urticaria - Across doses	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fatigue - Dose 1	72 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Headache - Dose 3	1 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Rash - Dose 3	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fatigue - Dose 2	53 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Rash - Dose 3	4 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Myalgia - Dose 1	32 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fatigue - Dose 3	68 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Headache - Across doses	5 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Gastrointestinal - Across doses	3 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fatigue - Across doses	116 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever - Dose 2	1 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Urticaria - Across doses	7 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fatigue - Dose 1	2 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Headache - Dose 1	27 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Myalgia - Dose 2	28 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fatigue - Dose 2	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever - Dose 1	3 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Gastrointestinal - Dose 1	4 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fatigue - Dose 3	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Headache - Dose 2	25 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Gastrointestinal - Dose 3	14 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fatigue - Across doses	2 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Rash - Across doses	11 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Myalgia - Dose 3	38 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fatigue - Dose 1	34 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Headache - Dose 3	25 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Urticaria - Dose 3	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fatigue - Dose 2	24 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Gastrointestinal - Dose 2	6 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Urticaria - Dose 2	2 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fatigue - Dose 3	40 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Headache - Across doses	48 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Myalgia - Across doses	62 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fatigue - Across doses	60 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever - Across doses	6 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Rash - Across doses	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever - Dose 1	7 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Myalgia - Dose 1	49 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Urticaria - Dose 1	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever - Dose 2	7 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Gastrointestinal - Dose 3	10 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Rash - Dose 1	7 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever - Dose 3	8 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Urticaria - Dose 1	3 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Myalgia - Dose 2	50 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever - Across doses	116 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Rash - Across doses	14 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Rash - Dose 2	4 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever - Dose 1	1 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Gastrointestinal - Across doses	33 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Myalgia - Dose 3	64 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever - Dose 2	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Gastrointestinal - Across doses	15 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Urticaria - Dose 1	1 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever - Dose 3	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Myalgia - Across doses	97 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Rash - Dose 3	5 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever - Across doses	1 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Urticaria - Dose 2	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever - Across doses	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever - Dose 1	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Urticaria - Dose 2	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever - Dose 2	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever - Dose 3	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Rash - Across doses	7 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fever - Across doses	3 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Gastrointestinal - Dose 1	12 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Gastrointestinal - Dose 2	14 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Rash - Dose 1	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Gastrointestinal - Dose 3	12 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Urticaria - Dose 2	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Gastrointestinal - Across doses	31 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Gastrointestinal - Dose 1	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Rash - Dose 2	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Gastrointestinal - Dose 2	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Gastrointestinal - Dose 3	2 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Gastrointestinal - Across doses	3 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Rash - Dose 3	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Gastrointestinal - Dose 1	7 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Gastrointestinal - Dose 2	6 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Gastrointestinal - Dose 3	5 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Rash - Across doses	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Gastrointestinal - Across doses	16 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Urticaria - Dose 3	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Headache - Dose 1	50 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Headache - Dose 2	44 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Rash - Dose 1	4 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Headache - Dose 3	39 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Headache - Across doses	82 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Headache - Dose 1	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Rash - Dose 2	3 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Headache - Dose 2	2 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Headache - Dose 3	4 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Headache - Across doses	6 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Rash - Dose 3	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Headache - Dose 1	25 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Urticaria - Across doses	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Headache - Dose 2	17 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Headache - Dose 3	23 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Rash - Across doses	7 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Headache - Across doses	46 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Urticaria - Dose 3	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Myalgia - Dose 1	48 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Myalgia - Dose 2	42 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Urticaria - Dose 1	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Myalgia - Dose 3	41 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Myalgia - Across doses	83 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Arthralgia - Dose 1	22 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Arthralgia - Dose 2	26 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Myalgia - Dose 1	2 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Arthralgia - Dose 3	22 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Urticaria - Dose 2	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Arthralgia - Across doses	47 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Arthralgia - Dose 1	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Myalgia - Dose 2	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Arthralgia - Dose 2	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Urticaria - Dose 1	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Arthralgia - Dose 3	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Arthralgia - Across doses	2 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Arthralgia - Dose 1	9 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Myalgia - Dose 3	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Arthralgia - Dose 2	12 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Urticaria - Dose 3	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Arthralgia - Dose 3	8 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Arthralgia - Across doses	22 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Myalgia - Across doses	4 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fatigue - Dose 1	47 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Urticaria - Across doss	2 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fatigue - Dose 2	48 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fatigue - Dose 3	50 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Myalgia - Dose 1	30 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fatigue - Across doses	81 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fatigue - Dose 1	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fatigue - Dose 2	2 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Myalgia - Dose 2	23 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fatigue - Dose 3	1 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Urticaria - Across doses	3 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fatigue - Across doses	4 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fatigue - Dose 1	25 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Myalgia - Dose 3	20 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fatigue - Dose 2	23 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fatigue - Dose 3	30 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Fatigue - Across doses	44 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Related Myalgia - Across doses	48 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever - Dose 1	2 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever - Dose 2	2 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever - Dose 3	2 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Rash - Dose 1	4 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Fever - Across doses	81 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever - Dose 1	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Rash - Dose 2	3 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever - Dose 2	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Urticaria - Dose 1	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Grade 3 Fever - Dose 3	0 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Any Rash - Dose 3	1 Participants

Secondary

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

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Time frame: During the 30-day (from the day of vaccination up to 29 subsequent days) post-vaccination period

Population: The analysis was based on the TVC, which included all subjects with at least one study vaccine administered and for whom data were available.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	Subjects with any Grade 3 AE(s)	2 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	Subjects with any AE(s)	43 Participants
Cervarix (15-25 Years) Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	Subjects with any Related AE(s)	13 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	Subjects with any Grade 3 AE(s)	0 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	Subjects with any AE(s)	46 Participants
Cervarix (26-45 Years) Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	Subjects with any Related AE(s)	18 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	Subjects with any AE(s)	28 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	Subjects with any Related AE(s)	6 Participants
Cervarix (46-55 Years) Group	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	Subjects with any Grade 3 AE(s)	4 Participants

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026

Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48

Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age

Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12

Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples

Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies, in Women 46 - 55 Years of Age

Number of Subjects Reporting Medically Significant Conditions

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

Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies

Number of Subjects Reporting Serious Adverse Events (SAE)

Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12

Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

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

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