Trial Outcomes & Findings for Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18 (NCT NCT00122681)

Last Updated: 2018-08-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

18729 participants

Primary outcome timeframe

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

Results posted on

2018-08-20

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Havrix Group Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Overall Study STARTED	9325	9319
Overall Study COMPLETED	7811	7798
Overall Study NOT COMPLETED	1514	1521

Reasons for withdrawal

Reasons for withdrawal
Measure	Havrix Group Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Overall Study Adverse Event	20	16
Overall Study Lost to Follow-up	1080	1097
Overall Study Protocol Violation	7	10
Overall Study Withdrawal by Subject	257	251
Overall Study Personal reasons	150	147

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Havrix Group n=9325 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=9319 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.	Total n=18644 Participants Total of all reporting groups
Age, Continuous	20.0 years STANDARD_DEVIATION 3.12 • n=93 Participants	20.0 years STANDARD_DEVIATION 3.10 • n=4 Participants	20.0 years STANDARD_DEVIATION 3.11 • n=27 Participants
Sex: Female, Male Female	9325 Participants n=93 Participants	9319 Participants n=4 Participants	18644 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Havrix Group n=7767 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=7814 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
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	4 Participants
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	2 Participants
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	2 Participants
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	6 Participants
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	4 Participants
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	2 Participants

PRIMARY outcome

Timeframe: at Month 48

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.

Outcome measures

Outcome measures
Measure	Havrix Group n=7760 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=7806 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
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	5 Participants
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	2 Participants
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	3 Participants
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	7 Participants
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	4 Participants
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	3 Participants

SECONDARY outcome

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.

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

Outcome measures

Outcome measures
Measure	Havrix Group n=7767 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=7814 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
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	8 Participants
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	5 Participants
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	3 Participants
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	12 Participants
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	9 Participants
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	3 Participants

SECONDARY outcome

Timeframe: 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-).

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.

Outcome measures

Outcome measures
Measure	Havrix Group n=3081 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=3078 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Number of Subjects Reporting Solicited Local and General Symptoms Pain, total	2403 Participants	2787 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Pain, sero+ or DNA+	622 Participants	743 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Pain, sero- & DNA-	1758 Participants	2013 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Pain, DNA+	166 Participants	219 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Redness, total	851 Participants	1349 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Redness, sero+ or DNA+	211 Participants	335 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Redness, sero- & DNA-	630 Participants	1005 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Redness, DNA+	56 Participants	96 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Swelling, total	609 Participants	1293 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Swelling, sero+ or DNA+	145 Participants	325 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Swelling, sero- & DNA-	454 Participants	959 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Swelling, DNA+	27 Participants	93 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Arthralgia, total	551 Participants	633 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Arthralgia, sero+ or DNA+	160 Participants	149 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Arthralgia, sero- & DNA-	384 Participants	480 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Arthralgia, DNA+	39 Participants	58 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Fatigue, total	1652 Participants	1771 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Fatigue, sero+ or DNA+	415 Participants	443 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Fatigue, sero- & DNA-	1215 Participants	1311 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Fatigue, DNA+	116 Participants	123 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Fever ≥ 37.5°C, total	342 Participants	385 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Fever ≥ 37.5°C, sero+ or DNA+	103 Participants	126 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Fever ≥ 37.5°C, sero- & DNA-	236 Participants	254 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Fever ≥ 37.5°C, DNA+	23 Participants	37 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Gastro-intestinal symptoms, total	847 Participants	856 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Gastro-intestinal,sero+ or DNA+	241 Participants	248 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Gastro-intestinal,sero- & DNA-	595 Participants	601 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Gastro-intestinal symptoms, DNA+	64 Participants	72 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Headache, total	1583 Participants	1668 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Headache, sero+ or DNA+	423 Participants	425 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Headache, sero- & DNA-	1141 Participants	1223 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Headache, DNA+	112 Participants	125 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Myalgia, total	1381 Participants	1607 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Myalgia, sero+ or DNA+	347 Participants	392 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Myalgia, sero- & DNA-	1019 Participants	1200 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Myalgia, DNA+	85 Participants	119 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Rash, total	258 Participants	314 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Rash, sero+ or DNA+	72 Participants	91 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Rash, sero- & DNA-	182 Participants	221 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Rash, DNA+	19 Participants	29 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Urticaria, total	244 Participants	300 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Urticaria, sero+ or DNA+	73 Participants	90 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Urticaria, sero- & DNA-	169 Participants	206 Participants
Number of Subjects Reporting Solicited Local and General Symptoms Urticaria, DNA+	14 Participants	25 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Havrix Group n=3187 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=3184 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Number of Subjects Reporting Unsolicited Adverse Events total	1466 Participants	1448 Participants
Number of Subjects Reporting Unsolicited Adverse Events sero+ DNA+	400 Participants	386 Participants
Number of Subjects Reporting Unsolicited Adverse Events sero- DNA-	1048 Participants	1049 Participants
Number of Subjects Reporting Unsolicited Adverse Events DNA+	111 Participants	122 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Havrix Group n=9325 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=9319 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Number of Subjects Reporting Serious Adverse Events (SAEs) Total	829 Participants	835 Participants
Number of Subjects Reporting Serious Adverse Events (SAEs) Sero + and DNA +	239 Participants	251 Participants
Number of Subjects Reporting Serious Adverse Events (SAEs) Sero- and DNA-	587 Participants	576 Participants
Number of Subjects Reporting Serious Adverse Events (SAEs) DNA+	69 Participants	82 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Havrix Group n=9325 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=9319 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Number of Subjects Reporting New Onset of Chronic Disease (NOCDs) Total	307 Participants	285 Participants
Number of Subjects Reporting New Onset of Chronic Disease (NOCDs) sero+ and DNA+	79 Participants	79 Participants
Number of Subjects Reporting New Onset of Chronic Disease (NOCDs) sero- and DNA-	225 Participants	201 Participants
Number of Subjects Reporting New Onset of Chronic Disease (NOCDs) DNA+	21 Participants	24 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Havrix Group n=9325 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=9319 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Number of Subjects Reporting Medically Significant Conditions Total	3378 Participants	3298 Participants
Number of Subjects Reporting Medically Significant Conditions sero+ DNA+	957 Participants	958 Participants
Number of Subjects Reporting Medically Significant Conditions sero- DNA-	2378 Participants	2303 Participants
Number of Subjects Reporting Medically Significant Conditions DNA+	285 Participants	296 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Havrix Group n=2257 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=2257 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
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	1642 subjects
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	77 subjects
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	26 subjects
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	212 subjects
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	2 subjects
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	20 subjects
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	205 subjects
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	16 subjects
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	41 subjects
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	4 subjects
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	12 subjects
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	1159 subjects
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	37 subjects
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	18 subjects
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	138 subjects
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	1 subjects
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	13 subjects
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	134 subjects
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	10 subjects
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	21 subjects
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	3 subjects
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	6 subjects
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	464 subjects
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	39 subjects
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	8 subjects
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	67 subjects
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	1 subjects
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	7 subjects
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	67 subjects
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	6 subjects
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	19 subjects
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	1 subjects
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	6 subjects
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	131 subjects
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	19 subjects
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	0 subjects
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	18 subjects
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	1 subjects
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	2 subjects
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	21 subjects
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	1 subjects
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	5 subjects
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	0 subjects
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	1 subjects

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Havrix Group n=7556 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=7619 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 HPV-16/18, DNA- & sero-	488 Participants	29 Participants
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 HPV-16, DNA- & sero-	337 Participants	22 Participants
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 HPV-18, DNA- & sero-	184 Participants	7 Participants
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 HPV-16/18, overall	540 Participants	37 Participants
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 HPV-16, overall	380 Participants	29 Participants
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 HPV-18, overall	195 Participants	8 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Havrix Group n=7572 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=7626 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 HPV-16/18, DNA- & sero-	588 Participants	35 Participants
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 HPV-16, DNA- & sero-	418 Participants	24 Participants
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 HPV-18, DNA- & sero-	212 Participants	11 Participants
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 HPV-16/18, overall	654 Participants	45 Participants
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 HPV-16, overall	473 Participants	31 Participants
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 HPV-18, overall	227 Participants	14 Participants

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Havrix Group n=7640 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=7665 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-16	380 Participants	29 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-18	195 Participants	8 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-31	199 Participants	45 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-33	100 Participants	55 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-35	43 Participants	55 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV- 39	149 Participants	147 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-45	79 Participants	19 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-51	354 Participants	304 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-52	315 Participants	293 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-56	174 Participants	182 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-58	101 Participants	111 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-59	59 Participants	56 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-66	178 Participants	168 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-68	134 Participants	138 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HRW-HPV	1351 Participants	1207 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HR-HPV	1607 Participants	1233 Participants

SECONDARY outcome

Timeframe: at Month 48

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

Outcome measures

Outcome measures
Measure	Havrix Group n=7656 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=7672 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-16	473 Participants	31 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-18	227 Participants	14 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-31	247 Participants	58 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-33	117 Participants	65 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-35	56 Participants	67 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-39	184 Participants	175 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-45	90 Participants	24 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-51	416 Participants	349 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-52	374 Participants	346 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-56	215 Participants	226 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-58	122 Participants	144 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-59	68 Participants	73 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-66	215 Participants	211 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HPV-68	169 Participants	165 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HRW-HPV	1556 Participants	1399 Participants
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types HR-HPV	1837 Participants	1424 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Havrix Group n=7760 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=7806 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
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	12 Participants
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	6 Participants
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	6 Participants
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	16 Participants
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	10 Participants
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	6 Participants

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Havrix Group n=7404 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=7466 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18 HPV-16/18, DNA- & sero-	227 Participants	20 Participants
Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18 HPV-16, DNA- & sero-	171 Participants	17 Participants
Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18 HPV-18, DNA- & sero-	66 Participants	3 Participants
Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18 HPV-16/18, overall	252 Participants	21 Participants
Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18 HPV-16, overall	192 Participants	18 Participants
Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18 HPV-18, overall	70 Participants	3 Participants

SECONDARY outcome

Timeframe: at Month 48

Outcome measures

Outcome measures
Measure	Havrix Group n=7461 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=7517 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18 HPV-16/18, DNA- & sero-	354 Participants	26 Participants
Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18 HPV-16, DNA- & sero-	269 Participants	19 Participants
Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18 HPV-18, DNA- & sero-	98 Participants	7 Participants
Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18 HPV-16/18, overall	388 Participants	28 Participants
Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18 HPV-16, overall	300 Participants	20 Participants
Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18 HPV-18, overall	103 Participants	8 Participants

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Havrix Group n=7764 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=7782 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
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	9 Participants
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	3 Participants
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	6 Participants
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	21 Participants
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	4 Participants
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	18 Participants
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	1 Participants
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	42 Participants
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	29 Participants
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	23 Participants
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	11 Participants
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	8 Participants
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	15 Participants
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	11 Participants

SECONDARY outcome

Timeframe: at Month 48

Outcome measures

Outcome measures
Measure	Havrix Group n=7757 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=7774 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
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	10 Participants
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	6 Participants
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	11 Participants
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	23 Participants
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	7 Participants
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	26 Participants
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	3 Participants
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	61 Participants
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	51 Participants
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	36 Participants
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	25 Participants
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	13 Participants
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	30 Participants
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	28 Participants

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Havrix Group n=7764 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=7782 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
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	4 Participants
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	2 Participants
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	2 Participants
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	12 Participants
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	1 Participants
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	3 Participants
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	0 Participants
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	10 Participants
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	12 Participants
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	4 Participants
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	6 Participants
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	1 Participants
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	4 Participants
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	5 Participants

SECONDARY outcome

Timeframe: at Month 48

Outcome measures

Outcome measures
Measure	Havrix Group n=7757 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=7774 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
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	4 Participants
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	3 Participants
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	5 Participants
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	13 Participants
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	3 Participants
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	4 Participants
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	2 Participants
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	21 Participants
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	24 Participants
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	7 Participants
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	15 Participants
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	1 Participants
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	7 Participants
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	11 Participants

SECONDARY outcome

Timeframe: 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.

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+)

Outcome measures

Outcome measures
Measure	Havrix Group n=898 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=1036 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
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	0 Participants
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	864 Participants
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	861 Participants
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	837 Participants
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	796 Participants
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	784 Participants
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	746 Participants
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	164 Participants
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	161 Participants
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	162 Participants
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	154 Participants
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	146 Participants
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	142 Participants
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	145 Participants
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	164 Participants
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	1025 Participants
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	1023 Participants
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	991 Participants
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	942 Participants
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	926 Participants
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	891 Participants
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	0 Participants
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	927 Participants
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	925 Participants
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	901 Participants
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	853 Participants
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	841 Participants
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	804 Participants
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	97 Participants
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	96 Participants
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	97 Participants
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	92 Participants
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	89 Participants
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	86 Participants
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	86 Participants
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	97 Participants
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	1023 Participants
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	1022 Participants
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	993 Participants
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	942 Participants
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	927 Participants
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	890 Participants

SECONDARY outcome

Timeframe: 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.

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 \[seronegative (sero-) or seropositive (sero+)\].

Outcome measures

Outcome measures
Measure	Havrix Group n=898 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=1036 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, sero-, pre-vaccination	4.0 EL.U/mL Interval 4.0 to 4.0	4.0 EL.U/mL Interval 4.0 to 4.0
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, sero-, Month 6	4.4 EL.U/mL Interval 4.2 to 4.5	630.7 EL.U/mL Interval 591.6 to 672.4
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, sero-, Month 7	4.4 EL.U/mL Interval 4.2 to 4.6	9206.5 EL.U/mL Interval 8609.4 to 9845.1
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, sero-, Month 12	4.3 EL.U/mL Interval 4.2 to 4.4	3281.1 EL.U/mL Interval 3064.5 to 3513.0
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, sero-, Month 24	4.4 EL.U/mL Interval 4.2 to 4.5	1592.0 EL.U/mL Interval 1491.6 to 1699.2
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, sero-, Month 36	4.4 EL.U/mL Interval 4.2 to 4.5	1265.1 EL.U/mL Interval 1184.8 to 1350.8
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, sero-, Month 48	4.6 EL.U/mL Interval 4.4 to 4.8	1174.3 EL.U/mL Interval 1096.1 to 1258.0
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, sero+, pre-vaccination	29.7 EL.U/mL Interval 25.0 to 35.4	28.9 EL.U/mL Interval 24.7 to 33.8
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, sero+, Month 6	24.4 EL.U/mL Interval 19.9 to 29.8	1256.9 EL.U/mL Interval 1030.1 to 1533.7
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, sero+, Month 7	21.7 EL.U/mL Interval 17.4 to 27.0	6423.1 EL.U/mL Interval 5486.3 to 7520.0
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, sero+, Month 12	20.2 EL.U/mL Interval 16.3 to 25.1	2909.6 EL.U/mL Interval 2504.3 to 3380.4
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, sero+, Month 24	18.7 EL.U/mL Interval 15.0 to 23.2	1573.2 EL.U/mL Interval 1356.7 to 1824.2
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, sero+, Month 36	17.7 EL.U/mL Interval 14.0 to 22.2	1244.3 EL.U/mL Interval 1068.9 to 1448.4
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, sero+, Month 48	18.3 EL.U/mL Interval 14.5 to 23.0	1115.9 EL.U/mL Interval 959.6 to 1297.7
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, total, pre-vaccination	5.6 EL.U/mL Interval 5.3 to 5.9	5.5 EL.U/mL Interval 5.2 to 5.8
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, total, Month 6	5.7 EL.U/mL Interval 5.4 to 6.1	703.2 EL.U/mL Interval 659.5 to 749.7
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, total, Month 7	5.6 EL.U/mL Interval 5.3 to 6.0	8695.7 EL.U/mL Interval 8171.9 to 9253.1
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, total, Month 12	5.5 EL.U/mL Interval 5.2 to 5.8	3220.5 EL.U/mL Interval 3026.4 to 3427.1
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, total, Month 24	5.6 EL.U/mL Interval 5.3 to 5.9	1589.1 EL.U/mL Interval 1497.2 to 1686.6
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, total, Month 36	5.4 EL.U/mL Interval 5.1 to 5.8	1261.9 EL.U/mL Interval 1188.3 to 1340.0
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-16, total, Month 48	5.7 EL.U/mL Interval 5.4 to 6.1	1164.6 EL.U/mL Interval 1093.9 to 1239.8
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, sero-, pre-vaccination	3.5 EL.U/mL Interval 3.5 to 3.5	3.5 EL.U/mL Interval 3.5 to 3.5
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, sero-, Month 6	3.7 EL.U/mL Interval 3.6 to 3.8	542.7 EL.U/mL Interval 510.2 to 577.2
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, sero-, Month 7	3.8 EL.U/mL Interval 3.6 to 3.9	4741.3 EL.U/mL Interval 4452.2 to 5049.1
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, sero-, Month 12	3.8 EL.U/mL Interval 3.7 to 3.9	1521.7 EL.U/mL Interval 1431.0 to 1618.1
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, sero-, Month 24	3.8 EL.U/mL Interval 3.7 to 3.9	704.4 EL.U/mL Interval 658.4 to 753.8
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, sero-, Month 36	3.7 EL.U/mL Interval 3.6 to 3.8	534.3 EL.U/mL Interval 498.9 to 572.1
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, sero-, Month 48	3.8 EL.U/mL Interval 3.7 to 3.9	476.2 EL.U/mL Interval 443.2 to 511.6
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, sero+, pre-vaccination	23.4 EL.U/mL Interval 18.9 to 29.1	24.8 EL.U/mL Interval 20.1 to 30.6
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, sero+, Month 6	19.6 EL.U/mL Interval 15.2 to 25.4	903.8 EL.U/mL Interval 714.0 to 1144.2
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, sero+, Month 7	20.8 EL.U/mL Interval 16.2 to 26.8	4135.7 EL.U/mL Interval 3548.6 to 4819.9
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, sero+, Month 12	19.9 EL.U/mL Interval 15.5 to 25.5	1509.5 EL.U/mL Interval 1271.3 to 1792.3
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, sero+, Month 24	18.9 EL.U/mL Interval 14.6 to 24.4	745.6 EL.U/mL Interval 620.1 to 896.6
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, sero+, Month 36	16.8 EL.U/mL Interval 12.8 to 22.1	580.9 EL.U/mL Interval 475.0 to 710.4
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, sero+, Month 48	16.5 EL.U/mL Interval 12.6 to 21.6	510.6 EL.U/mL Interval 415.7 to 627.2
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, total, pre-vaccination	4.4 EL.U/mL Interval 4.2 to 4.6	4.2 EL.U/mL Interval 4.0 to 4.4
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, total, Month 6	4.5 EL.U/mL Interval 4.3 to 4.8	569.5 EL.U/mL Interval 536.0 to 605.1
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, total, Month 7	4.6 EL.U/mL Interval 4.4 to 4.9	4680.5 EL.U/mL Interval 4413.4 to 4963.7
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, total, Month 12	4.6 EL.U/mL Interval 4.4 to 4.9	1520.5 EL.U/mL Interval 1435.0 to 1611.2
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, total, Month 24	4.7 EL.U/mL Interval 4.4 to 4.9	708.2 EL.U/mL Interval 664.6 to 754.8
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, total, Month 36	4.5 EL.U/mL Interval 4.3 to 4.8	538.5 EL.U/mL Interval 504.7 to 574.5
Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset Anti-HPV-18, total, Month 48	4.6 EL.U/mL Interval 4.3 to 4.8	479.4 EL.U/mL Interval 448.0 to 513.0

SECONDARY outcome

Timeframe: Month 0, 7, 12 and 24

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

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.

Outcome measures

Outcome measures
Measure	Havrix Group n=17 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=17 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test) pre-vaccination V5 HPV-16	0 Participants	0 Participants
HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test) Month 7 V5 HPV-16	0 Participants	17 Participants
HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test) Month 12 V5 HPV-16	0 Participants	2 Participants
HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test) Month 24 V5 HPV-16	0 Participants	17 Participants
HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test) pre-vaccination J4 HPV-18	0 Participants	1 Participants
HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test) Month 7 J4 HPV-18	0 Participants	17 Participants
HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test) Month 12 J4 HPV-18	1 Participants	1 Participants
HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test) Month 24 V5 HPV-18	1 Participants	11 Participants

SECONDARY outcome

Timeframe: Month 0, 7, 12, 24

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

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

Outcome measures

Outcome measures
Measure	Havrix Group n=17 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=17 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test) pre-vaccination V5 HPV-16	20.5 EL.U/mL Interval 20.5 to 20.5	20.5 EL.U/mL Interval 20.5 to 20.5
HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test) Month 7 V5 HPV-16	20.5 EL.U/mL Interval 20.5 to 20.5	816.7 EL.U/mL Interval 472.5 to 1411.4
HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test) Month 12 V5 HPV-16	20.5 EL.U/mL Interval 20.5 to 20.5	173.5 EL.U/mL Interval 25.1 to 1199.3
HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test) Month 24 V5 HPV-16	20.5 EL.U/mL Interval 20.5 to 20.5	163.3 EL.U/mL Interval 104.0 to 256.6
HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test) pre-vaccination J4 HPV-18	55.0 EL.U/mL Interval 55.0 to 55.0	57.7 EL.U/mL Interval 52.1 to 63.8
HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test) Month 7 J4 HPV-18	55.0 EL.U/mL Interval 55.0 to 55.0	679.2 EL.U/mL Interval 423.6 to 1088.9
HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test) Month 12 J4 HPV-18	71.0 EL.U/mL Interval 35.0 to 144.2	83.6 EL.U/mL Interval 0.4 to 17024.0
HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test) Month 24 V5 HPV-18	58.1 EL.U/mL Interval 51.7 to 65.2	139.5 EL.U/mL Interval 90.5 to 215.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Havrix Group n=47 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=48 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
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	0 Participants
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	46 Participants
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	45 Participants
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	46 Participants
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	41 Participants
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	40 Participants
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	0 Participants
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	46 Participants
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	44 Participants
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	46 Participants
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	41 Participants
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	39 Participants

SECONDARY outcome

Timeframe: 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.

Titers were expressed as GMTs.

Outcome measures

Outcome measures
Measure	Havrix Group n=47 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=48 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA) pre-vaccination HPV-16	20.0 titer Interval 20.0 to 20.0	20.0 titer Interval 20.0 to 20.0
Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA) Month 7 HPV-16	20.0 titer Interval 20.0 to 20.0	27364.8 titer Interval 19780.1 to 37857.9
Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA) Month 12 HPV-16	20.0 titer Interval 20.0 to 20.0	8385.9 titer Interval 5857.3 to 12006.0
Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA) Month 24 HPV-16	20.0 titer Interval 20.0 to 20.0	3647.4 titer Interval 2586.5 to 5143.4
Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA) Month 36 HPV-16	20.0 titer Interval 20.0 to 20.0	2245.1 titer Interval 1616.6 to 3117.9
Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA) Month 48 HPV-16	20.0 titer Interval 20.0 to 20.0	1931.1 titer Interval 1294.4 to 2880.8
Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA) pre-vaccination HPV-18	20.0 titer Interval 20.0 to 20.0	20.0 titer Interval 20.0 to 20.0
Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA) Month 7 HPV-18	20.0 titer Interval 20.0 to 20.0	9052.7 titer Interval 6851.8 to 11960.5
Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA) Month 12 HPV-18	20.0 titer Interval 20.0 to 20.0	1889.9 titer Interval 1316.0 to 2714.1
Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA) Month 24 HPV-18	20.0 titer Interval 20.0 to 20.0	1695.6 titer Interval 1200.7 to 2394.4
Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA) Month 36 HPV-18	20.0 titer Interval 20.0 to 20.0	1326.9 titer Interval 948.0 to 1857.3
Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA) Month 48 HPV-18	23.8 titer Interval 18.6 to 30.4	1078.1 titer Interval 714.9 to 1625.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Havrix Group n=1123 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=45 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 6-month Persistent Infection	7667.34 EL.U/mL Interval 7212.13 to 8151.29	6986.30 EL.U/mL Interval 5692.83 to 8573.66

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Havrix Group n=1123 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=45 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Number of Seroconverted Subjects for Anti-HPV-16 Without and With 6-month Persistent Infection.	1118 Participants	45 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Havrix Group n=1120 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=37 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 12-month Persistent Infection	7683.56 EL.U/mL Interval 7229.22 to 8166.44	6839.71 EL.U/mL Interval 5362.44 to 8723.96

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Havrix Group n=1120 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=37 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Number of Seroconverted Subjects for Anti-HPV-16 Without and With 12-month Persistent Infection	1115 Participants	37 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Havrix Group n=1248 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=28 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 6-month Persistent Infection	3963.50 EL.U/mL Interval 3750.71 to 4188.37	2945.69 EL.U/mL Interval 2271.74 to 3819.58

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Havrix Group n=1248 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=28 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Number of Seroconverted Subjects for Anti-HPV-18 Without and With 6-month Persistent Infection.	1242 Participants	28 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Havrix Group n=1243 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=21 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 12-month Persistent Infection	3965.67 EL.U/mL Interval 3753.09 to 4190.29	3063.23 EL.U/mL Interval 2261.65 to 4148.91

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Havrix Group n=1243 Participants Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=21 Participants Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
Number of Seroconverted Subjects for Anti-HPV-18 Without and With 12-month Persistent Infection	1237 Participants	21 Participants

Adverse Events

Havrix Group

Serious events: 829 serious events

Other events: 2678 other events

Deaths: 0 deaths

Cervarix Group

Serious events: 835 serious events

Other events: 2869 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Havrix Group n=9325 participants at risk Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine \[HAV\] (Havrix™-based investigational formulation) at Months 0, 1 and 6.	Cervarix Group n=9319 participants at risk Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus \[HPV\] vaccine) at Months 0, 1 and 6.
General disorders Pain at injection site	78.0% 2403/3080 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.	90.5% 2787/3078 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
General disorders Redness at injection site	27.6% 851/3080 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.	43.8% 1349/3078 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
General disorders Swelling at injection site	19.8% 609/3080 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.	42.0% 1293/3078 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
General disorders Arthralgia	17.9% 551/3081 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.	20.6% 633/3078 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
General disorders Fatigue	53.6% 1652/3081 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.	57.5% 1771/3078 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
General disorders Fever ≥ 37.5 degrees Celsius	11.1% 342/3081 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.	12.5% 385/3078 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
General disorders Gastro-intestinal symptoms	27.5% 847/3081 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.	27.8% 856/3078 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
General disorders Headache	51.4% 1583/3081 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.	54.2% 1668/3078 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
General disorders Myalgia	44.8% 1381/3081 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.	52.2% 1607/3078 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
General disorders Rash	8.4% 258/3081 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.	10.2% 314/3078 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
General disorders Urticaria	7.9% 244/3081 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.	9.7% 300/3078 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
Nervous system disorders Headache	7.8% 250/3187 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.	7.2% 228/3184 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
Infections and infestations Influenza	5.5% 176/3187 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.	4.9% 157/3184 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.
Infections and infestations Gynaecological Chlamydia infection	11.6% 1085/9325 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.	11.1% 1035/9319 • Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period. Results presented per group consist of a summary of the events (SAEs and AEs other than SAEs, respectively) reported, compiling overall number of subjects with events across the different periods of assessment.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER