Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18

A Phase III, Double-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia, Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Females 15-25 Years of Age.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00122681

Enrollment

18729

Registered

2005-07-22

Start date

2004-05-06

Completion date

2009-11-26

Last updated

2018-08-20

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

Conditions

Infections, Papillomavirus

Brief summary

Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes 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. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

NOTE: Some 178 centers participate in this study. Given that the recruitment is completed, the researchers have listed one center per country in this website. If required, further details of centers available on request.

Interventions

BIOLOGICALCervarix™

Intramuscular injection, 3 doses

BIOLOGICALHavrix™-based investigational formulation

Intramuscular injection, 3 doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 25 Years

Healthy volunteers

Yes

Inclusion criteria

* A woman whom the investigator believes that she and/or her parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). * A woman between, and including, 15 and 25 years of age at the time of the first vaccination. * Written informed consent must be obtained from the subject prior to enrollment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legal guardian of the subject and, in addition, the subject should sign and personally date a written informed assent). * Subject must be free of obvious health problems as established by medical history and clinical examination before entering into the study. * 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 the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series. * Has had no more than 6 lifetime sexual partners prior to enrollment. This criterion may not be applicable in subjects less than 18 years of age, according to local regulatory/ethical requirements. * Subject must have intact cervix.

Exclusion criteria

* Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study. * A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Months 0-8). * Previous administration of components of the investigational vaccine. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0-29) each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window. * Previous vaccination against human papillomavirus (HPV). * History of vaccination against Hepatitis A or a known clinical history of Hepatitis A disease. * History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test. * 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 vaccines. * Hypersensitivity to latex. * Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. * History of chronic condition(s) requiring treatment. * Received immunoglobulins and/or blood product within 90 days preceding enrollment. Enrollment will be deferred until the subject is outside of specified window. * Acute disease at the time of enrolment. * Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic exam cannot be performed. Enrollment will be deferred until condition is resolved according to investigator's medical judgement.

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3	CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: 1. DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). 2. Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.

Secondary

Measure	Time frame	Description
Number of Subjects Reporting Solicited Local and General Symptoms	Within 7 days after any vaccination	Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (measured in degree celsius (°C) by axillary route), gastrointestinal symptoms, headache, myalgia, rash and urticaria. Data are presented across the 3 doses.
Number of Subjects Reporting Unsolicited Adverse Events	Within 30 days after any vaccination	Unsolicited adverse event (AE) covers any AE 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.
Number of Subjects Reporting Serious Adverse Events (SAEs)	Throughout the entire study period (Month 0 to Month 48)	SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)	Throughout the entire study (Month 0 to 48)	NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Number of Subjects Reporting Medically Significant Conditions	Throughout entire study period (Month 0 to Month 48)	Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	Throughout the entire study period (Month 0 to Month 48)	Pregnancy outcomes are normal infant, premature infant, abnormal infant, elective termination, therapeutic abortion, ectopic pregnancy, spontaneous abortion, still birth, lost to follow-up, no pregnancy/molar pregnancy, pregnancy ongoing.
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3	Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in subjects: 1. DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0) 2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3	Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68
Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3	Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type (by PCR) over a 12-month interval (evaluations were planned at approximately 6-month intervals). Detection was done in subjects: 1. DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0) 2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline
Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3	Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.
Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3	CIN2+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer. Oncogenic types detected included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative at baseline, regardless of initial serostatus.
Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	At Months 6, 7, 12, 24, 36 & 48	Cut-off values assessed for seropositivity include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Results are presented for the total group and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA - seronegative (sero-) or seropositive (sero+)
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3	CIN1+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer. Detection was done in subjects: 1. DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0) 2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline
HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	Month 0, 7, 12 and 24	HPV-16 V5 cut-off was defined as greater than or equal to 41 ELU/mL. Only seronegative subjects were analysed. Seronegative subjects are subjects who had an antibody titer of less than 41 ELU/mL before vaccination. HPV-18 J4 cut-off was defined as greater than or equal to 110 EL.U/mL. Both seropositive and seronegative subjects were included in the analysis. Seropositive subjects were subjects with an antibody titer of greater than or equal to 110 EL.U/mL. Seronegative subjects were subjects with an antibody titer less than 110 EL.U/mL.
HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	Month 0, 7, 12, 24	Titers were expressed as GMTs in ELISA units per milliliter (EL.U/mL).
Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	At Month 0, 7, 12, 24, 36 and 48	Seropositivity was defined as subjects with a titer equal to or greater than 40. Subjects with an antibody titer smaller than 40 prior to vaccination were seronegative prior to vaccination and subjects with a titer equal to or greater than 40 were seropositive prior to vaccination.
Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	At month 0, 7, 12, 24, 36 and 48	Titers were expressed as GMTs.
Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 6-month Persistent Infection	At Month 7	GMT for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.
Number of Seroconverted Subjects for Anti-HPV-16 Without and With 6-month Persistent Infection.	At Month 7	Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence interval) was not calculated.
Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 12-month Persistent Infection	At Month 7	GMTs for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.
Number of Seroconverted Subjects for Anti-HPV-16 Without and With 12-month Persistent Infection	At Month 7	Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.
Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 6-month Persistent Infection	At Month 7	GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.
Number of Seroconverted Subjects for Anti-HPV-18 Without and With 6-month Persistent Infection.	At Month 7	Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.
Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 12-month Persistent Infection	At Month 7	GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.
Number of Seroconverted Subjects for Anti-HPV-18 Without and With 12-month Persistent Infection	At Month 7	Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	At Months 6, 7, 12, 24, 36 and 48	Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL). GMTs are presented for the total group and also stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA \[seronegative (sero-) or seropositive (sero+)\].

Countries

Australia, Belgium, Brazil, Canada, Finland, Germany, Italy, Mexico, Philippines, Spain, Taiwan, Thailand, United Kingdom, United States

Participant flow

Pre-assignment details

Of the 18729 subjects enrolled in the study, 64 subjects were not vaccinated. Within the 18665 subjects vaccinated, 21 subjects from 1 center were excluded from all analyses because of potential data discrepancies identified at this center. As a result, a total of 18644 subjects are reported as started in the participant flow.

Participants by arm

Arm	Count
Havrix Group Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	9,325
Cervarix Group Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.	9,319
Total	18,644

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	20	16
Overall Study	Lost to Follow-up	1,080	1,097
Overall Study	Personal reasons	150	147
Overall Study	Protocol Violation	7	10
Overall Study	Withdrawal by Subject	257	251

Baseline characteristics

Characteristic	Havrix Group	Cervarix Group	Total
Age, Continuous	20.0 years STANDARD_DEVIATION 3.12	20.0 years STANDARD_DEVIATION 3.1	20.0 years STANDARD_DEVIATION 3.11
Sex: Female, Male Female	9325 Participants	9319 Participants	18644 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	2,678 / 9,325	2,869 / 9,319
serious Total, serious adverse events	829 / 9,325	835 / 9,319

Outcome results

Primary

Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)

CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in subjects: 1. DNA- and sero-: HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0) 2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.

Time frame: at Month 48

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or Atypical Squamous Cells of Undetermined Significance (ASC-US) or Low-grade Squamous Intraepithelial Lesion (LSIL)) at Month 0.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-16/18, DNA- & sero- subjects	97 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-16, DNA- & sero- subjects	81 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-18, DNA- & sero- subjects	23 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-16/18, overall	108 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-16, overall	91 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-18, overall	24 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-16, overall	4 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-16/18, DNA- & sero- subjects	5 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-16/18, overall	7 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-16, DNA- & sero- subjects	2 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-18, overall	3 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-18, DNA- & sero- subjects	3 Participants

Comparison: Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed95% CI: [87.7, 98.4]

Comparison: Vaccine efficacy against CIN2+ associated with HPV-16 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed95% CI: [91, 99.7]

Comparison: Vaccine efficacy against CIN2+ associated with HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.95% CI: [57.2, 97.5]

Comparison: Vaccine efficacy against CIN2+ for HPV-16 or HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).95% CI: [86.3, 97.5]

Comparison: Vaccine efficacy against CIN2+ for HPV-16 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).95% CI: [88.5, 98.9]

Comparison: Vaccine efficacy against CIN2+ for HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).95% CI: [59.2, 97.6]

Primary

Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)

CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: 1. DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). 2. Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.

Time frame: Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-16/18, overall	65 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-16, DNA- & sero- subjects	46 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-16, overall	54 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-18, DNA- & sero- subjects	15 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-18, overall	16 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-16/18, DNA- & sero- subjects	56 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-18, overall	2 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-16/18, DNA- & sero- subjects	4 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-18, DNA- & sero- subjects	2 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-16/18, overall	6 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-16, overall	4 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)	HPV-16, DNA- & sero- subjects	2 Participants

Secondary

Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset

Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL). GMTs are presented for the total group and also stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA \[seronegative (sero-) or seropositive (sero+)\].

Time frame: At Months 6, 7, 12, 24, 36 and 48

Population: The analyses were performed on the ATP cohort for immunogenicity for whom immunogenicity data were available.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero+, Month 12	20.2 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero-, Month 6	4.4 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero-, Month 7	4.4 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero-, Month 12	4.3 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero-, Month 24	4.4 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero-, Month 36	4.4 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero-, Month 48	4.6 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero+, pre-vaccination	29.7 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero+, Month 6	24.4 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero+, Month 7	21.7 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero-, pre-vaccination	4.0 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero+, Month 24	18.7 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero+, Month 36	17.7 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero+, Month 48	18.3 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, total, pre-vaccination	5.6 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, total, Month 6	5.7 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, total, Month 7	5.6 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, total, Month 12	5.5 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, total, Month 24	5.6 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, total, Month 36	5.4 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, total, Month 48	5.7 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero-, pre-vaccination	3.5 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero-, Month 6	3.7 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero-, Month 7	3.8 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero-, Month 12	3.8 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero-, Month 24	3.8 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero-, Month 36	3.7 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero-, Month 48	3.8 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero+, pre-vaccination	23.4 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero+, Month 6	19.6 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero+, Month 7	20.8 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero+, Month 12	19.9 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero+, Month 24	18.9 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero+, Month 36	16.8 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero+, Month 48	16.5 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, total, pre-vaccination	4.4 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, total, Month 6	4.5 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, total, Month 7	4.6 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, total, Month 12	4.6 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, total, Month 24	4.7 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, total, Month 36	4.5 EL.U/mL
Havrix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, total, Month 48	4.6 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero+, Month 12	1509.5 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero-, pre-vaccination	4.0 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero-, pre-vaccination	3.5 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero-, Month 6	630.7 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, total, Month 24	708.2 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero-, Month 7	9206.5 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero-, Month 6	542.7 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero-, Month 12	3281.1 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero+, Month 24	745.6 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero-, Month 24	1592.0 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero-, Month 7	4741.3 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero-, Month 36	1265.1 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, total, Month 7	4680.5 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero-, Month 48	1174.3 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero-, Month 12	1521.7 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero+, pre-vaccination	28.9 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero+, Month 36	580.9 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero+, Month 6	1256.9 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero-, Month 24	704.4 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero+, Month 7	6423.1 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, total, Month 48	479.4 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero+, Month 12	2909.6 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero-, Month 36	534.3 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero+, Month 24	1573.2 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero+, Month 48	510.6 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero+, Month 36	1244.3 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero-, Month 48	476.2 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, sero+, Month 48	1115.9 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, total, Month 12	1520.5 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, total, pre-vaccination	5.5 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero+, pre-vaccination	24.8 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, total, Month 6	703.2 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, total, pre-vaccination	4.2 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, total, Month 7	8695.7 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero+, Month 6	903.8 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, total, Month 12	3220.5 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, total, Month 36	538.5 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, total, Month 24	1589.1 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, sero+, Month 7	4135.7 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, total, Month 36	1261.9 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-18, total, Month 6	569.5 EL.U/mL
Cervarix Group	Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset	Anti-HPV-16, total, Month 48	1164.6 EL.U/mL

Secondary

Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 12-month Persistent Infection

GMTs for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.

Time frame: At Month 7

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.

Arm	Measure	Value (GEOMETRIC_MEAN)
Havrix Group	Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 12-month Persistent Infection	7683.56 EL.U/mL
Cervarix Group	Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 12-month Persistent Infection	6839.71 EL.U/mL

Comparison: Hazard ratio of anti-HPV-16 GMTs at Month 7 (by ELISA) in subjects without 12-month persistent infection compared to subjects with 12-month persistent infection.p-value: 0.379695% CI: [0.444, 1.362]Chi-squared

Secondary

Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 6-month Persistent Infection

GMT for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.

Time frame: At Month 7

Arm	Measure	Value (GEOMETRIC_MEAN)
Havrix Group	Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 6-month Persistent Infection	7667.34 EL.U/mL
Cervarix Group	Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 6-month Persistent Infection	6986.30 EL.U/mL

Comparison: Hazard ratio of anti-HPV-16 GMTs at Month 7 (by ELISA) in subjects without 6-month persistent infection compared to subjects with 6-month persistent infectionp-value: 0.39195% CI: [0.476, 1.337]Chi-squared

Secondary

Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 12-month Persistent Infection

GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.

Time frame: At Month 7

Population: The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.

Arm	Measure	Value (GEOMETRIC_MEAN)
Havrix Group	Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 12-month Persistent Infection	3965.67 EL.U/mL
Cervarix Group	Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 12-month Persistent Infection	3063.23 EL.U/mL

Comparison: Hazard ratio of anti-HPV-18 GMTs at Month 7 (by ELISA) in subjects without 12-month persistent infection compared to subjects with 12-month persistent infection.p-value: 0.211195% CI: [0.312, 1.293]Chi-squared

Secondary

Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 6-month Persistent Infection

GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.

Time frame: At Month 7

Arm	Measure	Value (GEOMETRIC_MEAN)
Havrix Group	Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 6-month Persistent Infection	3963.50 EL.U/mL
Cervarix Group	Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 6-month Persistent Infection	2945.69 EL.U/mL

Comparison: Hazard ratio of anti-HPV-18 GMTs at Month 7 (by ELISA) in subjects without 6-month persistent infection compared to subjects with 6-month persistent infection.p-value: 0.103595% CI: [0.337, 1.106]Chi-squared

Secondary

HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)

Titers were expressed as GMTs in ELISA units per milliliter (EL.U/mL).

Time frame: Month 0, 7, 12, 24

Population: The analyses was performed on the Total Vaccinated cohort on subjects with available results.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Havrix Group	HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	pre-vaccination V5 HPV-16	20.5 EL.U/mL
Havrix Group	HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	Month 7 V5 HPV-16	20.5 EL.U/mL
Havrix Group	HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	Month 12 V5 HPV-16	20.5 EL.U/mL
Havrix Group	HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	Month 24 V5 HPV-16	20.5 EL.U/mL
Havrix Group	HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	pre-vaccination J4 HPV-18	55.0 EL.U/mL
Havrix Group	HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	Month 7 J4 HPV-18	55.0 EL.U/mL
Havrix Group	HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	Month 12 J4 HPV-18	71.0 EL.U/mL
Havrix Group	HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	Month 24 V5 HPV-18	58.1 EL.U/mL
Cervarix Group	HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	Month 24 V5 HPV-18	139.5 EL.U/mL
Cervarix Group	HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	pre-vaccination V5 HPV-16	20.5 EL.U/mL
Cervarix Group	HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	pre-vaccination J4 HPV-18	57.7 EL.U/mL
Cervarix Group	HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	Month 7 V5 HPV-16	816.7 EL.U/mL
Cervarix Group	HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	Month 12 J4 HPV-18	83.6 EL.U/mL
Cervarix Group	HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	Month 12 V5 HPV-16	173.5 EL.U/mL
Cervarix Group	HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	Month 7 J4 HPV-18	679.2 EL.U/mL
Cervarix Group	HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)	Month 24 V5 HPV-16	163.3 EL.U/mL

Secondary

HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)

HPV-16 V5 cut-off was defined as greater than or equal to 41 ELU/mL. Only seronegative subjects were analysed. Seronegative subjects are subjects who had an antibody titer of less than 41 ELU/mL before vaccination. HPV-18 J4 cut-off was defined as greater than or equal to 110 EL.U/mL. Both seropositive and seronegative subjects were included in the analysis. Seropositive subjects were subjects with an antibody titer of greater than or equal to 110 EL.U/mL. Seronegative subjects were subjects with an antibody titer less than 110 EL.U/mL.

Time frame: Month 0, 7, 12 and 24

Population: Analyses was performed on the Total Vaccinated Cohort on subjects with available results.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	pre-vaccination J4 HPV-18	0 Participants
Havrix Group	HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	Month 12 V5 HPV-16	0 Participants
Havrix Group	HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	Month 7 J4 HPV-18	0 Participants
Havrix Group	HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	pre-vaccination V5 HPV-16	0 Participants
Havrix Group	HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	Month 12 J4 HPV-18	1 Participants
Havrix Group	HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	Month 24 V5 HPV-16	0 Participants
Havrix Group	HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	Month 24 V5 HPV-18	1 Participants
Havrix Group	HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	Month 7 V5 HPV-16	0 Participants
Cervarix Group	HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	Month 24 V5 HPV-18	11 Participants
Cervarix Group	HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	pre-vaccination V5 HPV-16	0 Participants
Cervarix Group	HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	Month 12 V5 HPV-16	2 Participants
Cervarix Group	HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	Month 24 V5 HPV-16	17 Participants
Cervarix Group	HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	pre-vaccination J4 HPV-18	1 Participants
Cervarix Group	HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	Month 7 J4 HPV-18	17 Participants
Cervarix Group	HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	Month 12 J4 HPV-18	1 Participants
Cervarix Group	HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)	Month 7 V5 HPV-16	17 Participants

Secondary

Number of Seroconverted Subjects for Anti-HPV-16 Without and With 12-month Persistent Infection

Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.

Time frame: At Month 7

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Seroconverted Subjects for Anti-HPV-16 Without and With 12-month Persistent Infection	1115 Participants
Cervarix Group	Number of Seroconverted Subjects for Anti-HPV-16 Without and With 12-month Persistent Infection	37 Participants

Secondary

Number of Seroconverted Subjects for Anti-HPV-16 Without and With 6-month Persistent Infection.

Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence interval) was not calculated.

Time frame: At Month 7

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Seroconverted Subjects for Anti-HPV-16 Without and With 6-month Persistent Infection.	1118 Participants
Cervarix Group	Number of Seroconverted Subjects for Anti-HPV-16 Without and With 6-month Persistent Infection.	45 Participants

Secondary

Number of Seroconverted Subjects for Anti-HPV-18 Without and With 12-month Persistent Infection

Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.

Time frame: At Month 7

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Seroconverted Subjects for Anti-HPV-18 Without and With 12-month Persistent Infection	1237 Participants
Cervarix Group	Number of Seroconverted Subjects for Anti-HPV-18 Without and With 12-month Persistent Infection	21 Participants

Secondary

Number of Seroconverted Subjects for Anti-HPV-18 Without and With 6-month Persistent Infection.

Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.

Time frame: At Month 7

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Seroconverted Subjects for Anti-HPV-18 Without and With 6-month Persistent Infection.	1242 Participants
Cervarix Group	Number of Seroconverted Subjects for Anti-HPV-18 Without and With 6-month Persistent Infection.	28 Participants

Secondary

Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus

Cut-off values assessed for seropositivity include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. Results are presented for the total group and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA - seronegative (sero-) or seropositive (sero+)

Time frame: At Months 6, 7, 12, 24, 36 & 48

Population: The analyses were performed on the ATP cohort for immunogenicity on evaluable subjects for whom immunogenicity data were available.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero-, Month 12	30 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, total, Month 6	119 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, total, Month 7	122 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, total, Month 12	125 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, total, Month 24	121 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, total, Month 36	104 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, total, Month 48	102 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero-, pre-vaccination	0 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero-, Month 6	41 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero-, Month 7	34 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, total, pre-vaccination	108 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero-, Month 24	33 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero-, Month 36	35 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero-, Month 48	47 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero+, pre-vaccination	147 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero+, Month 6	119 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero+, Month 7	106 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero+, Month 12	101 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero+, Month 24	96 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero+, Month 36	88 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero+, Month 48	85 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, total, pre-vaccination	147 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, total, Month 6	160 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, total, Month 7	140 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, total, Month 12	131 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, total, Month 24	129 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, total, Month 36	123 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, total, Month 48	132 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero-, pre-vaccination	0 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero-, Month 6	29 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero-, Month 7	32 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero-, Month 12	36 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero-, Month 24	37 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero-, Month 36	31 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero-, Month 48	32 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero+, pre-vaccination	108 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero+, Month 6	90 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero+, Month 7	90 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero+, Month 12	89 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero+, Month 24	84 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero+, Month 36	73 Participants
Havrix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero+, Month 48	70 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero-, Month 12	901 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, total, pre-vaccination	97 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, total, pre-vaccination	164 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, total, Month 6	1023 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero+, Month 24	89 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, total, Month 7	1022 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, total, Month 6	1025 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, total, Month 12	993 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero-, Month 24	853 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, total, Month 24	942 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, total, Month 7	1023 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, total, Month 36	927 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero+, Month 7	97 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, total, Month 48	890 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, total, Month 12	991 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero-, pre-vaccination	0 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero-, Month 36	841 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero-, Month 6	864 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, total, Month 24	942 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero-, Month 7	861 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero+, Month 48	86 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero-, Month 12	837 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, total, Month 36	926 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero-, Month 24	796 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero-, Month 48	804 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero-, Month 36	784 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, total, Month 48	891 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero-, Month 48	746 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero+, Month 12	92 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero+, pre-vaccination	164 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero-, pre-vaccination	0 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero+, Month 6	161 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero+, pre-vaccination	97 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero+, Month 7	162 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero-, Month 6	927 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero+, Month 12	154 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero+, Month 36	86 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero+, Month 24	146 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero-, Month 7	925 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero+, Month 36	142 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-18, sero+, Month 6	96 Participants
Cervarix Group	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus	HPV-16, sero+, Month 48	145 Participants

Secondary

Number of Subjects Reporting Medically Significant Conditions

Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

Time frame: Throughout entire study period (Month 0 to Month 48)

Population: Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects Reporting Medically Significant Conditions	Total	3378 Participants
Havrix Group	Number of Subjects Reporting Medically Significant Conditions	sero+ DNA+	957 Participants
Havrix Group	Number of Subjects Reporting Medically Significant Conditions	sero- DNA-	2378 Participants
Havrix Group	Number of Subjects Reporting Medically Significant Conditions	DNA+	285 Participants
Cervarix Group	Number of Subjects Reporting Medically Significant Conditions	DNA+	296 Participants
Cervarix Group	Number of Subjects Reporting Medically Significant Conditions	Total	3298 Participants
Cervarix Group	Number of Subjects Reporting Medically Significant Conditions	sero- DNA-	2303 Participants
Cervarix Group	Number of Subjects Reporting Medically Significant Conditions	sero+ DNA+	958 Participants

Secondary

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

NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

Time frame: Throughout the entire study (Month 0 to 48)

Population: Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)	sero- and DNA-	225 Participants
Havrix Group	Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)	sero+ and DNA+	79 Participants
Havrix Group	Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)	DNA+	21 Participants
Havrix Group	Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)	Total	307 Participants
Cervarix Group	Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)	DNA+	24 Participants
Cervarix Group	Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)	sero+ and DNA+	79 Participants
Cervarix Group	Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)	sero- and DNA-	201 Participants
Cervarix Group	Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)	Total	285 Participants

Secondary

Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18

Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type (by PCR) over a 12-month interval (evaluations were planned at approximately 6-month intervals). Detection was done in subjects: 1. DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0) 2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 10 months of follow-up after Month 12

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-16/18, DNA- & sero-	227 Participants
Havrix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-16, DNA- & sero-	171 Participants
Havrix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-18, DNA- & sero-	66 Participants
Havrix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-16/18, overall	252 Participants
Havrix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-16, overall	192 Participants
Havrix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-18, overall	70 Participants
Cervarix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-16, overall	18 Participants
Cervarix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-16/18, DNA- & sero-	20 Participants
Cervarix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-16/18, overall	21 Participants
Cervarix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-16, DNA- & sero-	17 Participants
Cervarix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-18, overall	3 Participants
Cervarix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-18, DNA- & sero-	3 Participants

Secondary

Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18

Time frame: at Month 48

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-16/18, DNA- & sero-	354 Participants
Havrix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-16, DNA- & sero-	269 Participants
Havrix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-18, DNA- & sero-	98 Participants
Havrix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-16/18, overall	388 Participants
Havrix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-16, overall	300 Participants
Havrix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-18, overall	103 Participants
Cervarix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-16, overall	20 Participants
Cervarix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-16/18, DNA- & sero-	26 Participants
Cervarix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-16/18, overall	28 Participants
Cervarix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-16, DNA- & sero-	19 Participants
Cervarix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-18, overall	8 Participants
Cervarix Group	Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18	HPV-18, DNA- & sero-	7 Participants

Secondary

Number of Subjects Reporting Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Time frame: Throughout the entire study period (Month 0 to Month 48)

Population: Analysis was performed on the Total Vaccinated Cohort. The data are presented stratified by initial (Month 0) HPV-16/18 DNA status and according to HPV-16 or 18 serostatus (by ELISA).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects Reporting Serious Adverse Events (SAEs)	Total	829 Participants
Havrix Group	Number of Subjects Reporting Serious Adverse Events (SAEs)	Sero + and DNA +	239 Participants
Havrix Group	Number of Subjects Reporting Serious Adverse Events (SAEs)	Sero- and DNA-	587 Participants
Havrix Group	Number of Subjects Reporting Serious Adverse Events (SAEs)	DNA+	69 Participants
Cervarix Group	Number of Subjects Reporting Serious Adverse Events (SAEs)	DNA+	82 Participants
Cervarix Group	Number of Subjects Reporting Serious Adverse Events (SAEs)	Total	835 Participants
Cervarix Group	Number of Subjects Reporting Serious Adverse Events (SAEs)	Sero- and DNA-	576 Participants
Cervarix Group	Number of Subjects Reporting Serious Adverse Events (SAEs)	Sero + and DNA +	251 Participants

Secondary

Number of Subjects Reporting Solicited Local and General Symptoms

Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (measured in degree celsius (°C) by axillary route), gastrointestinal symptoms, headache, myalgia, rash and urticaria. Data are presented across the 3 doses.

Time frame: Within 7 days after any vaccination

Population: Analysis was performed on a safety subset of the Total vaccinated cohort, which included vaccinated subjects from certain sites. Data are presented for the total subset (total), then stratified subject HPV-16/18 DNA \& serostatus at baseline: DNA positive (DNA+) or negative (DNA-), ELISA seropositive (sero+) or seronegative (sero-).

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Fever ≥ 37.5°C, sero- & DNA-	236 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Swelling, sero- & DNA-	454 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Fever ≥ 37.5°C, DNA+	23 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Pain, total	2403 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Gastro-intestinal symptoms, total	847 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Swelling, DNA+	27 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Gastro-intestinal,sero+ or DNA+	241 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Redness, sero+ or DNA+	211 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Gastro-intestinal,sero- & DNA-	595 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Arthralgia, total	551 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Gastro-intestinal symptoms, DNA+	64 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Pain, sero- & DNA-	1758 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Headache, total	1583 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Arthralgia, sero+ or DNA+	160 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Headache, sero+ or DNA+	423 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Redness, sero- & DNA-	630 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Headache, sero- & DNA-	1141 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Arthralgia, sero- & DNA-	384 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Headache, DNA+	112 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Fatigue, sero+ or DNA+	415 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Myalgia, total	1381 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Arthralgia, DNA+	39 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Myalgia, sero+ or DNA+	347 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Redness, DNA+	56 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Myalgia, sero- & DNA-	1019 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Fatigue, total	1652 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Myalgia, DNA+	85 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Pain, DNA+	166 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Rash, total	258 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Fatigue, sero- & DNA-	1215 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Rash, sero+ or DNA+	72 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Swelling, total	609 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Rash, sero- & DNA-	182 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Fatigue, DNA+	116 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Rash, DNA+	19 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Pain, sero+ or DNA+	622 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Urticaria, total	244 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Fever ≥ 37.5°C, total	342 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Urticaria, sero+ or DNA+	73 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Swelling, sero+ or DNA+	145 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Urticaria, sero- & DNA-	169 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Fever ≥ 37.5°C, sero+ or DNA+	103 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Urticaria, DNA+	14 Participants
Havrix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Redness, total	851 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Urticaria, DNA+	25 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Pain, total	2787 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Pain, sero+ or DNA+	743 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Pain, sero- & DNA-	2013 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Pain, DNA+	219 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Redness, total	1349 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Redness, sero+ or DNA+	335 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Redness, sero- & DNA-	1005 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Redness, DNA+	96 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Swelling, total	1293 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Swelling, sero+ or DNA+	325 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Swelling, sero- & DNA-	959 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Swelling, DNA+	93 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Arthralgia, total	633 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Arthralgia, sero+ or DNA+	149 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Arthralgia, sero- & DNA-	480 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Arthralgia, DNA+	58 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Fatigue, sero+ or DNA+	443 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Fatigue, sero- & DNA-	1311 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Fatigue, DNA+	123 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Fever ≥ 37.5°C, total	385 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Fever ≥ 37.5°C, sero+ or DNA+	126 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Fever ≥ 37.5°C, sero- & DNA-	254 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Fever ≥ 37.5°C, DNA+	37 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Gastro-intestinal symptoms, total	856 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Gastro-intestinal,sero+ or DNA+	248 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Gastro-intestinal,sero- & DNA-	601 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Gastro-intestinal symptoms, DNA+	72 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Headache, total	1668 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Headache, sero+ or DNA+	425 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Headache, sero- & DNA-	1223 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Headache, DNA+	125 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Myalgia, total	1607 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Myalgia, sero+ or DNA+	392 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Myalgia, sero- & DNA-	1200 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Myalgia, DNA+	119 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Rash, total	314 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Rash, sero+ or DNA+	91 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Rash, sero- & DNA-	221 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Rash, DNA+	29 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Urticaria, total	300 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Urticaria, sero+ or DNA+	90 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Urticaria, sero- & DNA-	206 Participants
Cervarix Group	Number of Subjects Reporting Solicited Local and General Symptoms	Fatigue, total	1771 Participants

Secondary

Number of Subjects Reporting Unsolicited Adverse Events

Unsolicited adverse event (AE) covers any AE 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.

Time frame: Within 30 days after any vaccination

Population: Analysis was performed on the Safety Subset of the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects Reporting Unsolicited Adverse Events	total	1466 Participants
Havrix Group	Number of Subjects Reporting Unsolicited Adverse Events	sero+ DNA+	400 Participants
Havrix Group	Number of Subjects Reporting Unsolicited Adverse Events	sero- DNA-	1048 Participants
Havrix Group	Number of Subjects Reporting Unsolicited Adverse Events	DNA+	111 Participants
Cervarix Group	Number of Subjects Reporting Unsolicited Adverse Events	DNA+	122 Participants
Cervarix Group	Number of Subjects Reporting Unsolicited Adverse Events	total	1448 Participants
Cervarix Group	Number of Subjects Reporting Unsolicited Adverse Events	sero- DNA-	1049 Participants
Cervarix Group	Number of Subjects Reporting Unsolicited Adverse Events	sero+ DNA+	386 Participants

Secondary

Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)

Seropositivity was defined as subjects with a titer equal to or greater than 40. Subjects with an antibody titer smaller than 40 prior to vaccination were seronegative prior to vaccination and subjects with a titer equal to or greater than 40 were seropositive prior to vaccination.

Time frame: At Month 0, 7, 12, 24, 36 and 48

Population: The analyses were performed on the ATP cohort for immunogenicity which included subjects for whom immunogenicity data were available.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	pre-vaccination HPV-16	0 Participants
Havrix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 7 HPV-16	0 Participants
Havrix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 12 HPV-16	0 Participants
Havrix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 24 HPV-16	0 Participants
Havrix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 36 HPV-16	0 Participants
Havrix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 48 HPV-16	0 Participants
Havrix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	pre-vaccination HPV-18	0 Participants
Havrix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 7 HPV-18	0 Participants
Havrix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 12 HPV-18	0 Participants
Havrix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 24 HPV-18	0 Participants
Havrix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 36 HPV-18	0 Participants
Havrix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 48 HPV-18	2 Participants
Cervarix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 36 HPV-18	41 Participants
Cervarix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	pre-vaccination HPV-16	0 Participants
Cervarix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	pre-vaccination HPV-18	0 Participants
Cervarix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 7 HPV-16	46 Participants
Cervarix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 24 HPV-18	46 Participants
Cervarix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 12 HPV-16	45 Participants
Cervarix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 7 HPV-18	46 Participants
Cervarix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 24 HPV-16	46 Participants
Cervarix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 48 HPV-18	39 Participants
Cervarix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 36 HPV-16	41 Participants
Cervarix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 12 HPV-18	44 Participants
Cervarix Group	Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 48 HPV-16	40 Participants

Secondary

Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen

CIN1+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer. Detection was done in subjects: 1. DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0) 2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline

Time frame: at Month 48

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16/18, DNA- & sero-	165 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16, DNA- & sero-	124 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-18, DNA- & sero-	52 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16/18, overall	182 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16, overall	140 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-18, overall	53 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16, overall	10 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16/18, DNA- & sero-	12 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16/18, overall	16 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16, DNA- & sero-	6 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-18, overall	6 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-18, DNA- & sero-	6 Participants

Secondary

Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16/18, DNA- & sero-	96 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16, DNA- & sero-	70 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-18, DNA- & sero-	31 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16/18, overall	111 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16, overall	84 Participants
Havrix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-18, overall	32 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16, overall	9 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16/18, DNA- & sero-	8 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16/18, overall	12 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16, DNA- & sero-	5 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-18, overall	3 Participants
Cervarix Group	Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-18, DNA- & sero-	3 Participants

Secondary

Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen

Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.

Time frame: at Month 48

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16	140 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-18	53 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-31	79 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-33	66 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-35	18 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-39	48 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-45	25 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-51	96 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-52	81 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-56	45 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-58	42 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-59	20 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-66	44 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-68	43 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-58	25 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16	10 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-51	61 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-18	6 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-66	30 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-31	11 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-52	51 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-33	23 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-59	13 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-35	7 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-56	36 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-39	26 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-68	28 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-45	3 Participants

Secondary

Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16	84 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-18	32 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-31	49 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-33	34 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-35	13 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-39	29 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-45	12 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-51	57 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-52	44 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-56	26 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-58	34 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-59	12 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-66	24 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-68	22 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-58	11 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16	9 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-51	42 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-18	3 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-66	15 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-31	6 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-52	29 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-33	21 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-59	8 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-35	4 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-56	23 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-39	18 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-68	11 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-45	1 Participants

Secondary

Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen

CIN2+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer. Oncogenic types detected included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative at baseline, regardless of initial serostatus.

Time frame: at Month 48

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16	91 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-18	24 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-31	40 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-33	41 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-35	8 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-39	16 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-45	11 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-51	46 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-52	33 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-56	13 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-58	21 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-59	5 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-66	16 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-68	15 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-58	15 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16	4 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-51	21 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-18	3 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-66	7 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-31	5 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-52	24 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-33	13 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-59	1 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-35	3 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-56	7 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-39	4 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-68	11 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-45	2 Participants

Secondary

Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16	54 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-18	16 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-31	25 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-33	25 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-35	6 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-39	10 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-45	4 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-51	27 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-52	14 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-56	10 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-58	17 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-59	4 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-66	10 Participants
Havrix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-68	11 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-58	6 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-16	4 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-51	10 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-18	2 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-66	4 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-31	2 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-52	12 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-33	12 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-59	1 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-35	1 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-56	4 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-39	3 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-68	5 Participants
Cervarix Group	Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen	HPV-45	0 Participants

Secondary

Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus

Pregnancy outcomes are normal infant, premature infant, abnormal infant, elective termination, therapeutic abortion, ectopic pregnancy, spontaneous abortion, still birth, lost to follow-up, no pregnancy/molar pregnancy, pregnancy ongoing.

Time frame: Throughout the entire study period (Month 0 to Month 48)

Population: Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.

Arm	Measure	Group	Value (NUMBER)
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, lost to follow-up	42 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, therapeutic abortion	1 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, no pregnancy, molar pregnancy	1 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, ectopic pregnancy	0 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, pregnancy ongoing	11 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, pregnancy ongoing	3 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA- (n=1553, 1540), normal infant	1164 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, spontaneous abortion	18 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, premature birth	42 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, ectopic pregnancy	2 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, abnormal infant	15 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+(n=162, 199), normal infant	110 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, elective termination	162 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, normal infant	1671 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, therapeutic abortion	0 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, no pregnancy, molar pregnancy	0 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, ectopic pregnancy	7 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, premature birth	66 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, spontaneous abortion	125 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, premature infant	5 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA -, still birth	8 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, abnormal infant	22 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, lost to follow-up	21 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, still birth	0 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, no pregnancy, molar pregnancy	1 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, elective termination	228 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, pregnancy ongoing	8 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, abnormal infant	0 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, normal infant	486 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, therapeutic abortion	1 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, premature birth	24 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, pregnancy ongoing	1 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, abnormal infant	6 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, ectopic pregnancy	9 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, elective termination	62 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, elective termination	21 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, spontaneous abortion	68 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, spontaneous abortion	195 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, still birth	3 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, lost to follow-up	7 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, lost to follow-up	21 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, no pregnancy, molar pregnancy	0 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, still birth	11 subjects
Havrix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, therapeutic abortion	0 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, pregnancy ongoing	1 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, therapeutic abortion	1 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, still birth	6 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, lost to follow-up	19 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, no pregnancy, molar pregnancy	1 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, pregnancy ongoing	6 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+(n=162, 199), normal infant	131 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, premature infant	19 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, abnormal infant	0 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, elective termination	18 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, therapeutic abortion	1 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, ectopic pregnancy	2 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, spontaneous abortion	21 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, still birth	1 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, normal infant	1642 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, premature birth	77 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, abnormal infant	26 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, elective termination	212 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, therapeutic abortion	2 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, ectopic pregnancy	20 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, spontaneous abortion	205 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, still birth	16 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, lost to follow-up	41 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, no pregnancy, molar pregnancy	4 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	total, pregnancy ongoing	12 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA- (n=1553, 1540), normal infant	1159 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, premature birth	37 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, abnormal infant	18 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, elective termination	138 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, therapeutic abortion	1 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, ectopic pregnancy	13 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, spontaneous abortion	134 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA -, still birth	10 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, lost to follow-up	21 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, no pregnancy, molar pregnancy	3 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero- DNA-, pregnancy ongoing	6 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, normal infant	464 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, premature birth	39 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, abnormal infant	8 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, ectopic pregnancy	7 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, spontaneous abortion	67 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, lost to follow-up	5 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	DNA+, no pregnancy, molar pregnancy	0 subjects
Cervarix Group	Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus	sero+ DNA+, elective termination	67 subjects

Secondary

Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18

Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in subjects: 1. DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0) 2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.

Time frame: at Month 48

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-16/18, DNA- & sero-	588 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-16, DNA- & sero-	418 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-18, DNA- & sero-	212 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-16/18, overall	654 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-16, overall	473 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-18, overall	227 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-16, overall	31 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-16/18, DNA- & sero-	35 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-16/18, overall	45 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-16, DNA- & sero-	24 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-18, overall	14 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-18, DNA- & sero-	11 Participants

Secondary

Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-18, DNA- & sero-	184 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-16/18, overall	540 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-16, DNA- & sero-	337 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-16, overall	380 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-18, overall	195 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-16/18, DNA- & sero-	488 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-18, overall	8 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-16, overall	29 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-16/18, DNA- & sero-	29 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-16, DNA- & sero-	22 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-16/18, overall	37 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18	HPV-18, DNA- & sero-	7 Participants

Secondary

Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types

Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus. HRW-HPV = All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV = High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68

Time frame: at Month 48

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-16	473 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-52	374 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-35	56 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-56	215 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-31	247 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-58	122 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-39	184 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-59	68 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-18	227 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-66	215 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-45	90 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-68	169 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-33	117 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-51	416 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HR-HPV	1837 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HRW-HPV	1556 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HR-HPV	1424 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-16	31 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-18	14 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-31	58 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-33	65 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-35	67 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-39	175 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-45	24 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-51	349 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-52	346 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-56	226 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-58	144 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-59	73 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-66	211 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-68	165 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HRW-HPV	1399 Participants

Secondary

Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types

Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-16	380 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-18	195 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-31	199 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-33	100 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-35	43 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV- 39	149 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-45	79 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-51	354 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-52	315 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-56	174 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-58	101 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-59	59 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-66	178 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-68	134 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HRW-HPV	1351 Participants
Havrix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HR-HPV	1607 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HR-HPV	1233 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-16	29 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-52	293 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-18	8 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-66	168 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-31	45 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-56	182 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-33	55 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HRW-HPV	1207 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-35	55 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-58	111 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV- 39	147 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-68	138 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-45	19 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-59	56 Participants
Cervarix Group	Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types	HPV-51	304 Participants

Secondary

Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)

Titers were expressed as GMTs.

Time frame: At month 0, 7, 12, 24, 36 and 48

Population: The analyses were performed on the ATP cohort for immunogenicity for whom immunogenicity data were available.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Havrix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	pre-vaccination HPV-16	20.0 titer
Havrix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 7 HPV-16	20.0 titer
Havrix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 12 HPV-16	20.0 titer
Havrix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 24 HPV-16	20.0 titer
Havrix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 36 HPV-16	20.0 titer
Havrix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 48 HPV-16	20.0 titer
Havrix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	pre-vaccination HPV-18	20.0 titer
Havrix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 7 HPV-18	20.0 titer
Havrix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 12 HPV-18	20.0 titer
Havrix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 24 HPV-18	20.0 titer
Havrix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 36 HPV-18	20.0 titer
Havrix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 48 HPV-18	23.8 titer
Cervarix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 36 HPV-18	1326.9 titer
Cervarix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	pre-vaccination HPV-16	20.0 titer
Cervarix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	pre-vaccination HPV-18	20.0 titer
Cervarix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 7 HPV-16	27364.8 titer
Cervarix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 24 HPV-18	1695.6 titer
Cervarix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 12 HPV-16	8385.9 titer
Cervarix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 7 HPV-18	9052.7 titer
Cervarix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 24 HPV-16	3647.4 titer
Cervarix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 48 HPV-18	1078.1 titer
Cervarix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 36 HPV-16	2245.1 titer
Cervarix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 12 HPV-18	1889.9 titer
Cervarix Group	Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)	Month 48 HPV-16	1931.1 titer

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026

Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18

Conditions

Brief summary

Detailed description

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

Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)

Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection in Subjects HPV DNA Negative and Seronegative at Baseline or Overall (Any Serostatus at Baseline)

Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset

Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 12-month Persistent Infection

Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 6-month Persistent Infection

Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 12-month Persistent Infection

Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 6-month Persistent Infection

HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)

HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)

Number of Seroconverted Subjects for Anti-HPV-16 Without and With 12-month Persistent Infection

Number of Seroconverted Subjects for Anti-HPV-16 Without and With 6-month Persistent Infection.

Number of Seroconverted Subjects for Anti-HPV-18 Without and With 12-month Persistent Infection

Number of Seroconverted Subjects for Anti-HPV-18 Without and With 6-month Persistent Infection.

Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Antibody Titers by ELISA in the Immunogenicity Subset, According to Initial (Month 0) HPV-16 or HPV-18 Serostatus

Number of Subjects Reporting Medically Significant Conditions

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

Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18

Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18

Number of Subjects Reporting Serious Adverse Events (SAEs)

Number of Subjects Reporting Solicited Local and General Symptoms

Number of Subjects Reporting Unsolicited Adverse Events

Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)

Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen

Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen

Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen

Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen

Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen

Number of Subjects With Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen

Number of Subjects With Outcome of Pregnancies, Overall and Stratified by Initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus

Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18

Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18

Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types

Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types

Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)