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

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ClinicalTrials.gov Identifier: NCT00122681
Recruitment Status : Completed
First Posted : July 22, 2005
Results First Posted : January 20, 2010
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Interventions Biological: Cervarix™
Biological: Havrix™-based investigational formulation
Enrollment 18729

Recruitment Details  
Pre-assignment Details Of the 18729 subjects enrolled in the study, 64 subjects were not vaccinated. Within the 18665 subjects vaccinated, 21 subjects from 1 center were excluded from all analyses because of potential data discrepancies identified at this center. As a result, a total of 18644 subjects are reported as started in the participant flow.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6. Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Period Title: Overall Study
Started 9325 9319
Completed 7811 7798
Not Completed 1514 1521
Reason Not Completed
Adverse Event             20             16
Lost to Follow-up             1080             1097
Protocol Violation             7             10
Withdrawal by Subject             257             251
Personal reasons             150             147
Arm/Group Title Havrix Group Cervarix Group Total
Hide Arm/Group Description Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6. Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6. Total of all reporting groups
Overall Number of Baseline Participants 9325 9319 18644
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9325 participants 9319 participants 18644 participants
20.0  (3.12) 20.0  (3.10) 20.0  (3.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9325 participants 9319 participants 18644 participants
Female
9325
 100.0%
9319
 100.0%
18644
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title 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)
Hide Description

CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer.

Detection was done in:

  1. DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0).
  2. Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time Frame Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post-dose 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or Atypical Squamous Cells of Undetermined Significance (ASC-US) or Low-grade Squamous Intraepithelial Lesion (LSIL)) at Month 0.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 7767 7814
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- & sero- subjects Number Analyzed 7312 participants 7344 participants
56
   0.8%
4
   0.1%
HPV-16, DNA- & sero- subjects Number Analyzed 6165 participants 6303 participants
46
   0.7%
2
   0.0%
HPV-18, DNA- & sero- subjects Number Analyzed 6746 participants 6794 participants
15
   0.2%
2
   0.0%
HPV-16/18, overall Number Analyzed 7767 participants 7814 participants
65
   0.8%
6
   0.1%
HPV-16, overall Number Analyzed 7276 participants 7372 participants
54
   0.7%
4
   0.1%
HPV-18, overall Number Analyzed 7583 participants 7645 participants
16
   0.2%
2
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Havrix Group, Cervarix Group
Comments Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-Rate Ratio
Estimated Value 92.9
Confidence Interval (2-Sided) 95%
79.9 to 98.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Havrix Group, Cervarix Group
Comments Vaccine efficacy against CIN2+ associated with HPV-16 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-Rate Ratio
Estimated Value 95.7
Confidence Interval (2-Sided) 95%
82.9 to 99.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Havrix Group, Cervarix Group
Comments Vaccine efficacy against CIN2+ associated with HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-Rate Ratio
Estimated Value 86.7
Confidence Interval (2-Sided) 95%
39.7 to 98.7
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Havrix Group, Cervarix Group
Comments Vaccine efficacy against CIN2+ for HPV-16 or HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-Rate Ratio
Estimated Value 90.8
Confidence Interval (2-Sided) 95%
78.1 to 96.9
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Havrix Group, Cervarix Group
Comments Vaccine efficacy against CIN2+ for HPV-16 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-Rate Ratio
Estimated Value 92.7
Confidence Interval (2-Sided) 95%
79.3 to 98.2
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Havrix Group, Cervarix Group
Comments Vaccine efficacy against CIN2+ for HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-Rate Ratio
Estimated Value 87.6
Confidence Interval (2-Sided) 95%
44.1 to 98.8
Estimation Comments [Not Specified]
2.Primary Outcome
Title 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)
Hide Description

CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer.

Detection was done in subjects:

  1. DNA- and sero-: HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
  2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time Frame at Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or Atypical Squamous Cells of Undetermined Significance (ASC-US) or Low-grade Squamous Intraepithelial Lesion (LSIL)) at Month 0.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 7760 7806
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- & sero- subjects Number Analyzed 7305 participants 7338 participants
97
   1.3%
5
   0.1%
HPV-16, DNA- & sero- subjects Number Analyzed 6160 participants 6296 participants
81
   1.3%
2
   0.0%
HPV-18, DNA- & sero- subjects Number Analyzed 6739 participants 6789 participants
23
   0.3%
3
   0.0%
HPV-16/18, overall Number Analyzed 7760 participants 7806 participants
108
   1.4%
7
   0.1%
HPV-16, overall Number Analyzed 7267 participants 7364 participants
91
   1.3%
4
   0.1%
HPV-18, overall Number Analyzed 7577 participants 7638 participants
24
   0.3%
3
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Havrix Group, Cervarix Group
Comments Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-Rate Ratio
Estimated Value 94.9
Confidence Interval (2-Sided) 95%
87.7 to 98.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Havrix Group, Cervarix Group
Comments Vaccine efficacy against CIN2+ associated with HPV-16 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-Rate Ratio
Estimated Value 97.6
Confidence Interval (2-Sided) 95%
91.0 to 99.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Havrix Group, Cervarix Group
Comments Vaccine efficacy against CIN2+ associated with HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-Rate Ratio
Estimated Value 87.1
Confidence Interval (2-Sided) 95%
57.2 to 97.5
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Havrix Group, Cervarix Group
Comments Vaccine efficacy against CIN2+ for HPV-16 or HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-Rate Ratio
Estimated Value 93.6
Confidence Interval (2-Sided) 95%
86.3 to 97.5
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Havrix Group, Cervarix Group
Comments Vaccine efficacy against CIN2+ for HPV-16 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-Rate Ratio
Estimated Value 95.7
Confidence Interval (2-Sided) 95%
88.5 to 98.9
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Havrix Group, Cervarix Group
Comments Vaccine efficacy against CIN2+ for HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter 1-Rate Ratio
Estimated Value 87.6
Confidence Interval (2-Sided) 95%
59.2 to 97.6
Estimation Comments [Not Specified]
3.Secondary Outcome
Title 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
Hide Description

CIN1+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.

Detection was done in subjects:

  1. DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
  2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline
Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 7767 7814
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- & sero- Number Analyzed 7312 participants 7344 participants
96
   1.3%
8
   0.1%
HPV-16, DNA- & sero- Number Analyzed 6165 participants 6303 participants
70
   1.1%
5
   0.1%
HPV-18, DNA- & sero- Number Analyzed 6746 participants 6794 participants
31
   0.5%
3
   0.0%
HPV-16/18, overall Number Analyzed 7767 participants 7814 participants
111
   1.4%
12
   0.2%
HPV-16, overall Number Analyzed 7276 participants 7372 participants
84
   1.2%
9
   0.1%
HPV-18, overall Number Analyzed 7583 participants 7645 participants
32
   0.4%
3
   0.0%
4.Secondary Outcome
Title Number of Subjects Reporting Solicited Local and General Symptoms
Hide Description

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

Data are presented across the 3 doses.

Time Frame Within 7 days after any vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on a safety subset of the Total vaccinated cohort, which included vaccinated subjects from certain sites. Data are presented for the total subset (total), then stratified subject HPV-16/18 DNA & serostatus at baseline: DNA positive (DNA+) or negative (DNA-), ELISA seropositive (sero+) or seronegative (sero-).
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 3081 3078
Measure Type: Count of Participants
Unit of Measure: Participants
Pain, total Number Analyzed 3080 participants 3078 participants
2403
  78.0%
2787
  90.5%
Pain, sero+ or DNA+ Number Analyzed 827 participants 830 participants
622
  75.2%
743
  89.5%
Pain, sero- & DNA- Number Analyzed 2219 participants 2211 participants
1758
  79.2%
2013
  91.0%
Pain, DNA+ Number Analyzed 212 participants 236 participants
166
  78.3%
219
  92.8%
Redness, total Number Analyzed 3080 participants 3078 participants
851
  27.6%
1349
  43.8%
Redness, sero+ or DNA+ Number Analyzed 827 participants 830 participants
211
  25.5%
335
  40.4%
Redness, sero- & DNA- Number Analyzed 2219 participants 2211 participants
630
  28.4%
1005
  45.5%
Redness, DNA+ Number Analyzed 212 participants 236 participants
56
  26.4%
96
  40.7%
Swelling, total Number Analyzed 3080 participants 3078 participants
609
  19.8%
1293
  42.0%
Swelling, sero+ or DNA+ Number Analyzed 827 participants 830 participants
145
  17.5%
325
  39.2%
Swelling, sero- & DNA- Number Analyzed 2219 participants 2211 participants
454
  20.5%
959
  43.4%
Swelling, DNA+ Number Analyzed 212 participants 236 participants
27
  12.7%
93
  39.4%
Arthralgia, total Number Analyzed 3081 participants 3078 participants
551
  17.9%
633
  20.6%
Arthralgia, sero+ or DNA+ Number Analyzed 828 participants 830 participants
160
  19.3%
149
  18.0%
Arthralgia, sero- & DNA- Number Analyzed 2219 participants 2211 participants
384
  17.3%
480
  21.7%
Arthralgia, DNA+ Number Analyzed 212 participants 236 participants
39
  18.4%
58
  24.6%
Fatigue, total Number Analyzed 3081 participants 3078 participants
1652
  53.6%
1771
  57.5%
Fatigue, sero+ or DNA+ Number Analyzed 828 participants 830 participants
415
  50.1%
443
  53.4%
Fatigue, sero- & DNA- Number Analyzed 2219 participants 2211 participants
1215
  54.8%
1311
  59.3%
Fatigue, DNA+ Number Analyzed 212 participants 236 participants
116
  54.7%
123
  52.1%
Fever ≥ 37.5°C, total Number Analyzed 3081 participants 3078 participants
342
  11.1%
385
  12.5%
Fever ≥ 37.5°C, sero+ or DNA+ Number Analyzed 828 participants 830 participants
103
  12.4%
126
  15.2%
Fever ≥ 37.5°C, sero- & DNA- Number Analyzed 2219 participants 2211 participants
236
  10.6%
254
  11.5%
Fever ≥ 37.5°C, DNA+ Number Analyzed 212 participants 236 participants
23
  10.8%
37
  15.7%
Gastro-intestinal symptoms, total Number Analyzed 3081 participants 3078 participants
847
  27.5%
856
  27.8%
Gastro-intestinal,sero+ or DNA+ Number Analyzed 828 participants 830 participants
241
  29.1%
248
  29.9%
Gastro-intestinal,sero- & DNA- Number Analyzed 2219 participants 2211 participants
595
  26.8%
601
  27.2%
Gastro-intestinal symptoms, DNA+ Number Analyzed 212 participants 236 participants
64
  30.2%
72
  30.5%
Headache, total Number Analyzed 3081 participants 3078 participants
1583
  51.4%
1668
  54.2%
Headache, sero+ or DNA+ Number Analyzed 828 participants 830 participants
423
  51.1%
425
  51.2%
Headache, sero- & DNA- Number Analyzed 2219 participants 2211 participants
1141
  51.4%
1223
  55.3%
Headache, DNA+ Number Analyzed 212 participants 236 participants
112
  52.8%
125
  53.0%
Myalgia, total Number Analyzed 3081 participants 3078 participants
1381
  44.8%
1607
  52.2%
Myalgia, sero+ or DNA+ Number Analyzed 828 participants 830 participants
347
  41.9%
392
  47.2%
Myalgia, sero- & DNA- Number Analyzed 2219 participants 2211 participants
1019
  45.9%
1200
  54.3%
Myalgia, DNA+ Number Analyzed 212 participants 236 participants
85
  40.1%
119
  50.4%
Rash, total Number Analyzed 3081 participants 3078 participants
258
   8.4%
314
  10.2%
Rash, sero+ or DNA+ Number Analyzed 828 participants 830 participants
72
   8.7%
91
  11.0%
Rash, sero- & DNA- Number Analyzed 2219 participants 2211 participants
182
   8.2%
221
  10.0%
Rash, DNA+ Number Analyzed 212 participants 236 participants
19
   9.0%
29
  12.3%
Urticaria, total Number Analyzed 3081 participants 3078 participants
244
   7.9%
300
   9.7%
Urticaria, sero+ or DNA+ Number Analyzed 828 participants 830 participants
73
   8.8%
90
  10.8%
Urticaria, sero- & DNA- Number Analyzed 2219 participants 2211 participants
169
   7.6%
206
   9.3%
Urticaria, DNA+ Number Analyzed 212 participants 236 participants
14
   6.6%
25
  10.6%
5.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events
Hide Description Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time Frame Within 30 days after any vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Safety Subset of the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 3187 3184
Measure Type: Count of Participants
Unit of Measure: Participants
total Number Analyzed 3187 participants 3184 participants
1466
  46.0%
1448
  45.5%
sero+ DNA+ Number Analyzed 858 participants 854 participants
400
  46.6%
386
  45.2%
sero- DNA- Number Analyzed 2289 participants 2290 participants
1048
  45.8%
1049
  45.8%
DNA+ Number Analyzed 222 participants 243 participants
111
  50.0%
122
  50.2%
6.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame Throughout the entire study period (Month 0 to Month 48)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort. The data are presented stratified by initial (Month 0) HPV-16/18 DNA status and according to HPV-16 or 18 serostatus (by ELISA).
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 9325 9319
Measure Type: Count of Participants
Unit of Measure: Participants
Total Number Analyzed 9325 participants 9319 participants
829
   8.9%
835
   9.0%
Sero + and DNA + Number Analyzed 2419 participants 2409 participants
239
   9.9%
251
  10.4%
Sero- and DNA- Number Analyzed 6789 participants 6804 participants
587
   8.6%
576
   8.5%
DNA+ Number Analyzed 649 participants 690 participants
69
  10.6%
82
  11.9%
7.Secondary Outcome
Title Number of Subjects Reporting New Onset of Chronic Disease (NOCDs)
Hide Description NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame Throughout the entire study (Month 0 to 48)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 9325 9319
Measure Type: Count of Participants
Unit of Measure: Participants
Total Number Analyzed 9325 participants 9319 participants
307
   3.3%
285
   3.1%
sero+ and DNA+ Number Analyzed 2419 participants 2409 participants
79
   3.3%
79
   3.3%
sero- and DNA- Number Analyzed 6789 participants 6804 participants
225
   3.3%
201
   3.0%
DNA+ Number Analyzed 649 participants 690 participants
21
   3.2%
24
   3.5%
8.Secondary Outcome
Title Number of Subjects Reporting Medically Significant Conditions
Hide Description Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time Frame Throughout entire study period (Month 0 to Month 48)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 9325 9319
Measure Type: Count of Participants
Unit of Measure: Participants
Total Number Analyzed 9325 participants 9319 participants
3378
  36.2%
3298
  35.4%
sero+ DNA+ Number Analyzed 2419 participants 2409 participants
957
  39.6%
958
  39.8%
sero- DNA- Number Analyzed 6789 participants 6804 participants
2378
  35.0%
2303
  33.8%
DNA+ Number Analyzed 649 participants 690 participants
285
  43.9%
296
  42.9%
9.Secondary Outcome
Title 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
Hide Description Pregnancy outcomes are normal infant, premature infant, abnormal infant, elective termination, therapeutic abortion, ectopic pregnancy, spontaneous abortion, still birth, lost to follow-up, no pregnancy/molar pregnancy, pregnancy ongoing.
Time Frame Throughout the entire study period (Month 0 to Month 48)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Total Vaccinated Cohort and stratified according to initial (Month 0) HPV-16/18 DNA Status and According to HPV-16 or -18 Serostatus.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 2257 2257
Measure Type: Number
Unit of Measure: subjects
total, normal infant Number Analyzed 2257 participants 2257 participants
1671 1642
total, premature birth Number Analyzed 2257 participants 2257 participants
66 77
total, abnormal infant Number Analyzed 2257 participants 2257 participants
22 26
total, elective termination Number Analyzed 2257 participants 2257 participants
228 212
total, therapeutic abortion Number Analyzed 2257 participants 2257 participants
1 2
total, ectopic pregnancy Number Analyzed 2257 participants 2257 participants
9 20
total, spontaneous abortion Number Analyzed 2257 participants 2257 participants
195 205
total, still birth Number Analyzed 2257 participants 2257 participants
11 16
total, lost to follow-up Number Analyzed 2257 participants 2257 participants
42 41
total, no pregnancy, molar pregnancy Number Analyzed 2257 participants 2257 participants
1 4
total, pregnancy ongoing Number Analyzed 2257 participants 2257 participants
11 12
sero- DNA- (n=1553, 1540), normal infant Number Analyzed 1553 participants 1540 participants
1164 1159
sero- DNA-, premature birth Number Analyzed 2257 participants 2257 participants
42 37
sero- DNA-, abnormal infant Number Analyzed 2257 participants 2257 participants
15 18
sero- DNA-, elective termination Number Analyzed 2257 participants 2257 participants
162 138
sero- DNA-, therapeutic abortion Number Analyzed 2257 participants 2257 participants
0 1
sero- DNA-, ectopic pregnancy Number Analyzed 2257 participants 2257 participants
7 13
sero- DNA-, spontaneous abortion Number Analyzed 2257 participants 2257 participants
125 134
sero- DNA -, still birth Number Analyzed 2257 participants 2257 participants
8 10
sero- DNA-, lost to follow-up Number Analyzed 2257 participants 2257 participants
21 21
sero- DNA-, no pregnancy, molar pregnancy Number Analyzed 2257 participants 2257 participants
1 3
sero- DNA-, pregnancy ongoing Number Analyzed 2257 participants 2257 participants
8 6
sero+ DNA+, normal infant Number Analyzed 2257 participants 2257 participants
486 464
sero+ DNA+, premature birth Number Analyzed 2257 participants 2257 participants
24 39
sero+ DNA+, abnormal infant Number Analyzed 2257 participants 2257 participants
6 8
sero+ DNA+, elective termination Number Analyzed 2257 participants 2257 participants
62 67
sero+ DNA+, therapeutic abortion Number Analyzed 2257 participants 2257 participants
1 1
sero+ DNA+, ectopic pregnancy Number Analyzed 2257 participants 2257 participants
2 7
sero+ DNA+, spontaneous abortion Number Analyzed 2257 participants 2257 participants
68 67
sero+ DNA+, still birth Number Analyzed 2257 participants 2257 participants
3 6
sero+ DNA+, lost to follow-up Number Analyzed 2257 participants 2257 participants
21 19
sero+ DNA+, no pregnancy, molar pregnancy Number Analyzed 2257 participants 2257 participants
0 1
sero+ DNA+, pregnancy ongoing Number Analyzed 2257 participants 2257 participants
3 6
DNA+(n=162, 199), normal infant Number Analyzed 2257 participants 2257 participants
110 131
DNA+, premature infant Number Analyzed 2257 participants 2257 participants
5 19
DNA+, abnormal infant Number Analyzed 2257 participants 2257 participants
0 0
DNA+, elective termination Number Analyzed 2257 participants 2257 participants
21 18
DNA+, therapeutic abortion Number Analyzed 2257 participants 2257 participants
0 1
DNA+, ectopic pregnancy Number Analyzed 2257 participants 2257 participants
0 2
DNA+, spontaneous abortion Number Analyzed 2257 participants 2257 participants
18 21
DNA+, still birth Number Analyzed 2257 participants 2257 participants
0 1
DNA+, lost to follow-up Number Analyzed 2257 participants 2257 participants
7 5
DNA+, no pregnancy, molar pregnancy Number Analyzed 2257 participants 2257 participants
0 0
DNA+, pregnancy ongoing Number Analyzed 2257 participants 2257 participants
1 1
10.Secondary Outcome
Title Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18
Hide Description

Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.

Detection was done in subjects:

  1. DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
  2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline
Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 7556 7619
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- & sero- Number Analyzed 7122 participants 7177 participants
488
   6.9%
29
   0.4%
HPV-16, DNA- & sero- Number Analyzed 6018 participants 6163 participants
337
   5.6%
22
   0.4%
HPV-18, DNA- & sero- Number Analyzed 6567 participants 6642 participants
184
   2.8%
7
   0.1%
HPV-16/18, overall Number Analyzed 7556 participants 7619 participants
540
   7.1%
37
   0.5%
HPV-16, overall Number Analyzed 7085 participants 7196 participants
380
   5.4%
29
   0.4%
HPV-18, overall Number Analyzed 7377 participants 7457 participants
195
   2.6%
8
   0.1%
11.Secondary Outcome
Title Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18
Hide Description

Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval.

Detection was done in subjects:

  1. DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
  2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time Frame at Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine, who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 7572 7626
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- & sero- Number Analyzed 7137 participants 7182 participants
588
   8.2%
35
   0.5%
HPV-16, DNA- & sero- Number Analyzed 6029 participants 6165 participants
418
   6.9%
24
   0.4%
HPV-18, DNA- & sero- Number Analyzed 6581 participants 6649 participants
212
   3.2%
11
   0.2%
HPV-16/18, overall Number Analyzed 7572 participants 7626 participants
654
   8.6%
45
   0.6%
HPV-16, overall Number Analyzed 7099 participants 7202 participants
473
   6.7%
31
   0.4%
HPV-18, overall Number Analyzed 7394 participants 7465 participants
227
   3.1%
14
   0.2%
12.Secondary Outcome
Title Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types
Hide Description

Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.

HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68

Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 7640 7665
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 7085 participants 7196 participants
380
   5.4%
29
   0.4%
HPV-18 Number Analyzed 7377 participants 7457 participants
195
   2.6%
8
   0.1%
HPV-31 Number Analyzed 7398 participants 7394 participants
199
   2.7%
45
   0.6%
HPV-33 Number Analyzed 7496 participants 7527 participants
100
   1.3%
55
   0.7%
HPV-35 Number Analyzed 7553 participants 7572 participants
43
   0.6%
55
   0.7%
HPV- 39 Number Analyzed 7411 participants 7423 participants
149
   2.0%
147
   2.0%
HPV-45 Number Analyzed 7540 participants 7587 participants
79
   1.0%
19
   0.3%
HPV-51 Number Analyzed 7152 participants 7188 participants
354
   4.9%
304
   4.2%
HPV-52 Number Analyzed 7221 participants 7280 participants
315
   4.4%
293
   4.0%
HPV-56 Number Analyzed 7435 participants 7460 participants
174
   2.3%
182
   2.4%
HPV-58 Number Analyzed 7494 participants 7512 participants
101
   1.3%
111
   1.5%
HPV-59 Number Analyzed 7514 participants 7528 participants
59
   0.8%
56
   0.7%
HPV-66 Number Analyzed 7358 participants 7405 participants
178
   2.4%
168
   2.3%
HPV-68 Number Analyzed 7409 participants 7441 participants
134
   1.8%
138
   1.9%
HRW-HPV Number Analyzed 7640 participants 7665 participants
1351
  17.7%
1207
  15.7%
HR-HPV Number Analyzed 7640 participants 7665 participants
1607
  21.0%
1233
  16.1%
13.Secondary Outcome
Title Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types
Hide Description

Oncogenic types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.

HRW-HPV = All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV = High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68

Time Frame at Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 5 months of follow-up after Month 12.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 7656 7672
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 7099 participants 7202 participants
473
   6.7%
31
   0.4%
HPV-18 Number Analyzed 7394 participants 7465 participants
227
   3.1%
14
   0.2%
HPV-31 Number Analyzed 7414 participants 7400 participants
247
   3.3%
58
   0.8%
HPV-33 Number Analyzed 7513 participants 7534 participants
117
   1.6%
65
   0.9%
HPV-35 Number Analyzed 7569 participants 7579 participants
56
   0.7%
67
   0.9%
HPV-39 Number Analyzed 7428 participants 7429 participants
184
   2.5%
175
   2.4%
HPV-45 Number Analyzed 7556 participants 7594 participants
90
   1.2%
24
   0.3%
HPV-51 Number Analyzed 7165 participants 7190 participants
416
   5.8%
349
   4.9%
HPV-52 Number Analyzed 7237 participants 7289 participants
374
   5.2%
346
   4.7%
HPV-56 Number Analyzed 7451 participants 7467 participants
215
   2.9%
226
   3.0%
HPV-58 Number Analyzed 7511 participants 7518 participants
122
   1.6%
144
   1.9%
HPV-59 Number Analyzed 7530 participants 7536 participants
68
   0.9%
73
   1.0%
HPV-66 Number Analyzed 7375 participants 7412 participants
215
   2.9%
211
   2.8%
HPV-68 Number Analyzed 7424 participants 7450 participants
169
   2.3%
165
   2.2%
HRW-HPV Number Analyzed 7656 participants 7672 participants
1556
  20.3%
1399
  18.2%
HR-HPV Number Analyzed 7656 participants 7672 participants
1837
  24.0%
1424
  18.6%
14.Secondary Outcome
Title 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
Hide Description

CIN1+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.

Detection was done in subjects:

  1. DNA- and sero-: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and sero- for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0)
  2. Overall: subjects HPV DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline
Time Frame at Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 7760 7806
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- & sero- Number Analyzed 7305 participants 7338 participants
165
   2.3%
12
   0.2%
HPV-16, DNA- & sero- Number Analyzed 6160 participants 6296 participants
124
   2.0%
6
   0.1%
HPV-18, DNA- & sero- Number Analyzed 6739 participants 6789 participants
52
   0.8%
6
   0.1%
HPV-16/18, overall Number Analyzed 7760 participants 7806 participants
182
   2.3%
16
   0.2%
HPV-16, overall Number Analyzed 7267 participants 7364 participants
140
   1.9%
10
   0.1%
HPV-18, overall Number Analyzed 7577 participants 7638 participants
53
   0.7%
6
   0.1%
15.Secondary Outcome
Title Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18
Hide Description

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
Time Frame Up to the moment when 36 cases of CIN2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months post dose 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 10 months of follow-up after Month 12
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 7404 7466
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- & sero- Number Analyzed 6984 participants 7035 participants
227
   3.3%
20
   0.3%
HPV-16, DNA- & sero- Number Analyzed 5903 participants 6052 participants
171
   2.9%
17
   0.3%
HPV-18, DNA- & sero- Number Analyzed 6440 participants 6508 participants
66
   1.0%
3
   0.0%
HPV-16/18, overall Number Analyzed 7404 participants 7466 participants
252
   3.4%
21
   0.3%
HPV-16, overall Number Analyzed 6941 participants 7057 participants
192
   2.8%
18
   0.3%
HPV-18, overall Number Analyzed 7231 participants 7307 participants
70
   1.0%
3
   0.0%
16.Secondary Outcome
Title Number of Subjects Reporting Persistent Infection (12-month Definition) With HPV-16 or HPV-18
Hide Description

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
Time Frame at Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all evaluable subjects, who had received 3 doses of study vaccine and who had a normal or low-grade cytology (i.e. negative or ASC-US or LSIL) at Month 0. All subjects had at least 10 months of follow-up after Month 12.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 7461 7517
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16/18, DNA- & sero- Number Analyzed 7038 participants 7082 participants
354
   5.0%
26
   0.4%
HPV-16, DNA- & sero- Number Analyzed 5949 participants 6089 participants
269
   4.5%
19
   0.3%
HPV-18, DNA- & sero- Number Analyzed 6490 participants 6552 participants
98
   1.5%
7
   0.1%
HPV-16/18, overall Number Analyzed 7461 participants 7517 participants
388
   5.2%
28
   0.4%
HPV-16, overall Number Analyzed 6996 participants 7103 participants
300
   4.3%
20
   0.3%
HPV-18, overall Number Analyzed 7288 participants 7356 participants
103
   1.4%
8
   0.1%
17.Secondary Outcome
Title 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
Hide Description

Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.

Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 7764 7782
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 7276 participants 7372 participants
84
   1.2%
9
   0.1%
HPV-18 Number Analyzed 7583 participants 7645 participants
32
   0.4%
3
   0.0%
HPV-31 Number Analyzed 7599 participants 7583 participants
49
   0.6%
6
   0.1%
HPV-33 Number Analyzed 7706 participants 7720 participants
34
   0.4%
21
   0.3%
HPV-35 Number Analyzed 7764 participants 7768 participants
13
   0.2%
4
   0.1%
HPV-39 Number Analyzed 7614 participants 7609 participants
29
   0.4%
18
   0.2%
HPV-45 Number Analyzed 7745 participants 7782 participants
12
   0.2%
1
   0.0%
HPV-51 Number Analyzed 7352 participants 7363 participants
57
   0.8%
42
   0.6%
HPV-52 Number Analyzed 7414 participants 7461 participants
44
   0.6%
29
   0.4%
HPV-56 Number Analyzed 7638 participants 7646 participants
26
   0.3%
23
   0.3%
HPV-58 Number Analyzed 7702 participants 7709 participants
34
   0.4%
11
   0.1%
HPV-59 Number Analyzed 7723 participants 7720 participants
12
   0.2%
8
   0.1%
HPV-66 Number Analyzed 7564 participants 7592 participants
24
   0.3%
15
   0.2%
HPV-68 Number Analyzed 7614 participants 7633 participants
22
   0.3%
11
   0.1%
18.Secondary Outcome
Title 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
Hide Description

Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Detection was done in subjects who were HPV DNA negative at baseline regardless of initial serostatus.

Time Frame at Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 7757 7774
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 7267 participants 7364 participants
140
   1.9%
10
   0.1%
HPV-18 Number Analyzed 7577 participants 7638 participants
53
   0.7%
6
   0.1%
HPV-31 Number Analyzed 7592 participants 7575 participants
79
   1.0%
11
   0.1%
HPV-33 Number Analyzed 7700 participants 7712 participants
66
   0.9%
23
   0.3%
HPV-35 Number Analyzed 7757 participants 7760 participants
18
   0.2%
7
   0.1%
HPV-39 Number Analyzed 7608 participants 7602 participants
48
   0.6%
26
   0.3%
HPV-45 Number Analyzed 7738 participants 7774 participants
25
   0.3%
3
   0.0%
HPV-51 Number Analyzed 7341 participants 7356 participants
96
   1.3%
61
   0.8%
HPV-52 Number Analyzed 7409 participants 7455 participants
81
   1.1%
51
   0.7%
HPV-56 Number Analyzed 7631 participants 7638 participants
45
   0.6%
36
   0.5%
HPV-58 Number Analyzed 7696 participants 7701 participants
42
   0.5%
25
   0.3%
HPV-59 Number Analyzed 7716 participants 7713 participants
20
   0.3%
13
   0.2%
HPV-66 Number Analyzed 7559 participants 7583 participants
44
   0.6%
30
   0.4%
HPV-68 Number Analyzed 7606 participants 7626 participants
43
   0.6%
28
   0.4%
19.Secondary Outcome
Title 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
Hide Description

CIN2+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.

Oncogenic types detected included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Detection was done in subjects who were HPV DNA negative at baseline, regardless of initial serostatus.

Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 7764 7782
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 7276 participants 7372 participants
54
   0.7%
4
   0.1%
HPV-18 Number Analyzed 7583 participants 7645 participants
16
   0.2%
2
   0.0%
HPV-31 Number Analyzed 7599 participants 7583 participants
25
   0.3%
2
   0.0%
HPV-33 Number Analyzed 7706 participants 7720 participants
25
   0.3%
12
   0.2%
HPV-35 Number Analyzed 7764 participants 7768 participants
6
   0.1%
1
   0.0%
HPV-39 Number Analyzed 7614 participants 7609 participants
10
   0.1%
3
   0.0%
HPV-45 Number Analyzed 7745 participants 7782 participants
4
   0.1%
0
   0.0%
HPV-51 Number Analyzed 7352 participants 7363 participants
27
   0.4%
10
   0.1%
HPV-52 Number Analyzed 7414 participants 7461 participants
14
   0.2%
12
   0.2%
HPV-56 Number Analyzed 7638 participants 7646 participants
10
   0.1%
4
   0.1%
HPV-58 Number Analyzed 7702 participants 7709 participants
17
   0.2%
6
   0.1%
HPV-59 Number Analyzed 7723 participants 7720 participants
4
   0.1%
1
   0.0%
HPV-66 Number Analyzed 7564 participants 7592 participants
10
   0.1%
4
   0.1%
HPV-68 Number Analyzed 7614 participants 7633 participants
11
   0.1%
5
   0.1%
20.Secondary Outcome
Title 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
Hide Description

CIN2+ was defined as histopathologically-confirmed lesions including cervical intraepithelial neoplasia of grade 2 (CIN2), grade 3 (CIN3), AIS and invasive cervical cancer.

Oncogenic types detected included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.

Detection was done in subjects who were HPV DNA negative at baseline, regardless of initial serostatus.

Time Frame at Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 7757 7774
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 7267 participants 7364 participants
91
   1.3%
4
   0.1%
HPV-18 Number Analyzed 7577 participants 7638 participants
24
   0.3%
3
   0.0%
HPV-31 Number Analyzed 7592 participants 7575 participants
40
   0.5%
5
   0.1%
HPV-33 Number Analyzed 7700 participants 7712 participants
41
   0.5%
13
   0.2%
HPV-35 Number Analyzed 7757 participants 7760 participants
8
   0.1%
3
   0.0%
HPV-39 Number Analyzed 7608 participants 7602 participants
16
   0.2%
4
   0.1%
HPV-45 Number Analyzed 7738 participants 7774 participants
11
   0.1%
2
   0.0%
HPV-51 Number Analyzed 7341 participants 7356 participants
46
   0.6%
21
   0.3%
HPV-52 Number Analyzed 7409 participants 7455 participants
33
   0.4%
24
   0.3%
HPV-56 Number Analyzed 7631 participants 7638 participants
13
   0.2%
7
   0.1%
HPV-58 Number Analyzed 7696 participants 7701 participants
21
   0.3%
15
   0.2%
HPV-59 Number Analyzed 7716 participants 7713 participants
5
   0.1%
1
   0.0%
HPV-66 Number Analyzed 7559 participants 7583 participants
16
   0.2%
7
   0.1%
HPV-68 Number Analyzed 7606 participants 7626 participants
15
   0.2%
11
   0.1%
21.Secondary Outcome
Title 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
Hide Description

Cut-off values assessed for seropositivity include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.

Results are presented for the total group and stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA - seronegative (sero-) or seropositive (sero+)

Time Frame At Months 6, 7, 12, 24, 36 & 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the ATP cohort for immunogenicity on evaluable subjects for whom immunogenicity data were available.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 898 1036
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16, sero-, pre-vaccination Number Analyzed 750 participants 872 participants
0
   0.0%
0
   0.0%
HPV-16, sero-, Month 6 Number Analyzed 738 participants 865 participants
41
   5.6%
864
  99.9%
HPV-16, sero-, Month 7 Number Analyzed 740 participants 865 participants
34
   4.6%
861
  99.5%
HPV-16, sero-, Month 12 Number Analyzed 719 participants 839 participants
30
   4.2%
837
  99.8%
HPV-16, sero-, Month 24 Number Analyzed 672 participants 797 participants
33
   4.9%
796
  99.9%
HPV-16, sero-, Month 36 Number Analyzed 664 participants 784 participants
35
   5.3%
784
 100.0%
HPV-16, sero-, Month 48 Number Analyzed 603 participants 746 participants
47
   7.8%
746
 100.0%
HPV-16, sero+, pre-vaccination Number Analyzed 147 participants 164 participants
147
 100.0%
164
 100.0%
HPV-16, sero+, Month 6 Number Analyzed 139 participants 162 participants
119
  85.6%
161
  99.4%
HPV-16, sero+, Month 7 Number Analyzed 139 participants 163 participants
106
  76.3%
162
  99.4%
HPV-16, sero+, Month 12 Number Analyzed 134 participants 154 participants
101
  75.4%
154
 100.0%
HPV-16, sero+, Month 24 Number Analyzed 138 participants 146 participants
96
  69.6%
146
 100.0%
HPV-16, sero+, Month 36 Number Analyzed 127 participants 142 participants
88
  69.3%
142
 100.0%
HPV-16, sero+, Month 48 Number Analyzed 118 participants 145 participants
85
  72.0%
145
 100.0%
HPV-16, total, pre-vaccination Number Analyzed 897 participants 1036 participants
147
  16.4%
164
  15.8%
HPV-16, total, Month 6 Number Analyzed 877 participants 1027 participants
160
  18.2%
1025
  99.8%
HPV-16, total, Month 7 Number Analyzed 879 participants 1028 participants
140
  15.9%
1023
  99.5%
HPV-16, total, Month 12 Number Analyzed 853 participants 993 participants
131
  15.4%
991
  99.8%
HPV-16, total, Month 24 Number Analyzed 810 participants 943 participants
129
  15.9%
942
  99.9%
HPV-16, total, Month 36 Number Analyzed 791 participants 926 participants
123
  15.5%
926
 100.0%
HPV-16, total, Month 48 Number Analyzed 721 participants 891 participants
132
  18.3%
891
 100.0%
HPV-18, sero-, pre-vaccination Number Analyzed 790 participants 939 participants
0
   0.0%
0
   0.0%
HPV-18, sero-, Month 6 Number Analyzed 771 participants 930 participants
29
   3.8%
927
  99.7%
HPV-18, sero-, Month 7 Number Analyzed 772 participants 930 participants
32
   4.1%
925
  99.5%
HPV-18, sero-, Month 12 Number Analyzed 748 participants 901 participants
36
   4.8%
901
 100.0%
HPV-18, sero-, Month 24 Number Analyzed 698 participants 854 participants
37
   5.3%
853
  99.9%
HPV-18, sero-, Month 36 Number Analyzed 691 participants 841 participants
31
   4.5%
841
 100.0%
HPV-18, sero-, Month 48 Number Analyzed 633 participants 806 participants
32
   5.1%
804
  99.8%
HPV-18, sero+, pre-vaccination Number Analyzed 108 participants 97 participants
108
 100.0%
97
 100.0%
HPV-18, sero+, Month 6 Number Analyzed 105 participants 97 participants
90
  85.7%
96
  99.0%
HPV-18, sero+, Month 7 Number Analyzed 105 participants 97 participants
90
  85.7%
97
 100.0%
HPV-18, sero+, Month 12 Number Analyzed 106 participants 92 participants
89
  84.0%
92
 100.0%
HPV-18, sero+, Month 24 Number Analyzed 102 participants 89 participants
84
  82.4%
89
 100.0%
HPV-18, sero+, Month 36 Number Analyzed 98 participants 86 participants
73
  74.5%
86
 100.0%
HPV-18, sero+, Month 48 Number Analyzed 91 participants 86 participants
70
  76.9%
86
 100.0%
HPV-18, total, pre-vaccination Number Analyzed 898 participants 1036 participants
108
  12.0%
97
   9.4%
HPV-18, total, Month 6 Number Analyzed 876 participants 1027 participants
119
  13.6%
1023
  99.6%
HPV-18, total, Month 7 Number Analyzed 877 participants 1027 participants
122
  13.9%
1022
  99.5%
HPV-18, total, Month 12 Number Analyzed 854 participants 993 participants
125
  14.6%
993
 100.0%
HPV-18, total, Month 24 Number Analyzed 800 participants 943 participants
121
  15.1%
942
  99.9%
HPV-18, total, Month 36 Number Analyzed 789 participants 927 participants
104
  13.2%
927
 100.0%
HPV-18, total, Month 48 Number Analyzed 724 participants 892 participants
102
  14.1%
890
  99.8%
22.Secondary Outcome
Title Anti-HPV-16 and Anti-HPV-18 ELISA Titers in the Immunogenicity Subset
Hide Description

Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL).

GMTs are presented for the total group and also stratified according to initial (Month 0) HPV-16 or HPV-18 serostatus by ELISA [seronegative (sero-) or seropositive (sero+)].

Time Frame At Months 6, 7, 12, 24, 36 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the ATP cohort for immunogenicity for whom immunogenicity data were available.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 898 1036
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-HPV-16, sero-, pre-vaccination Number Analyzed 750 participants 872 participants
4.0
(4.0 to 4.0)
4.0
(4.0 to 4.0)
Anti-HPV-16, sero-, Month 6 Number Analyzed 738 participants 865 participants
4.4
(4.2 to 4.5)
630.7
(591.6 to 672.4)
Anti-HPV-16, sero-, Month 7 Number Analyzed 740 participants 865 participants
4.4
(4.2 to 4.6)
9206.5
(8609.4 to 9845.1)
Anti-HPV-16, sero-, Month 12 Number Analyzed 719 participants 839 participants
4.3
(4.2 to 4.4)
3281.1
(3064.5 to 3513.0)
Anti-HPV-16, sero-, Month 24 Number Analyzed 672 participants 797 participants
4.4
(4.2 to 4.5)
1592.0
(1491.6 to 1699.2)
Anti-HPV-16, sero-, Month 36 Number Analyzed 664 participants 784 participants
4.4
(4.2 to 4.5)
1265.1
(1184.8 to 1350.8)
Anti-HPV-16, sero-, Month 48 Number Analyzed 603 participants 746 participants
4.6
(4.4 to 4.8)
1174.3
(1096.1 to 1258.0)
Anti-HPV-16, sero+, pre-vaccination Number Analyzed 147 participants 164 participants
29.7
(25.0 to 35.4)
28.9
(24.7 to 33.8)
Anti-HPV-16, sero+, Month 6 Number Analyzed 139 participants 162 participants
24.4
(19.9 to 29.8)
1256.9
(1030.1 to 1533.7)
Anti-HPV-16, sero+, Month 7 Number Analyzed 139 participants 163 participants
21.7
(17.4 to 27.0)
6423.1
(5486.3 to 7520.0)
Anti-HPV-16, sero+, Month 12 Number Analyzed 134 participants 154 participants
20.2
(16.3 to 25.1)
2909.6
(2504.3 to 3380.4)
Anti-HPV-16, sero+, Month 24 Number Analyzed 138 participants 146 participants
18.7
(15.0 to 23.2)
1573.2
(1356.7 to 1824.2)
Anti-HPV-16, sero+, Month 36 Number Analyzed 127 participants 142 participants
17.7
(14.0 to 22.2)
1244.3
(1068.9 to 1448.4)
Anti-HPV-16, sero+, Month 48 Number Analyzed 118 participants 145 participants
18.3
(14.5 to 23.0)
1115.9
(959.6 to 1297.7)
Anti-HPV-16, total, pre-vaccination Number Analyzed 897 participants 1036 participants
5.6
(5.3 to 5.9)
5.5
(5.2 to 5.8)
Anti-HPV-16, total, Month 6 Number Analyzed 877 participants 1027 participants
5.7
(5.4 to 6.1)
703.2
(659.5 to 749.7)
Anti-HPV-16, total, Month 7 Number Analyzed 879 participants 1028 participants
5.6
(5.3 to 6.0)
8695.7
(8171.9 to 9253.1)
Anti-HPV-16, total, Month 12 Number Analyzed 853 participants 993 participants
5.5
(5.2 to 5.8)
3220.5
(3026.4 to 3427.1)
Anti-HPV-16, total, Month 24 Number Analyzed 810 participants 943 participants
5.6
(5.3 to 5.9)
1589.1
(1497.2 to 1686.6)
Anti-HPV-16, total, Month 36 Number Analyzed 791 participants 926 participants
5.4
(5.1 to 5.8)
1261.9
(1188.3 to 1340.0)
Anti-HPV-16, total, Month 48 Number Analyzed 721 participants 891 participants
5.7
(5.4 to 6.1)
1164.6
(1093.9 to 1239.8)
Anti-HPV-18, sero-, pre-vaccination Number Analyzed 790 participants 939 participants
3.5
(3.5 to 3.5)
3.5
(3.5 to 3.5)
Anti-HPV-18, sero-, Month 6 Number Analyzed 771 participants 930 participants
3.7
(3.6 to 3.8)
542.7
(510.2 to 577.2)
Anti-HPV-18, sero-, Month 7 Number Analyzed 772 participants 930 participants
3.8
(3.6 to 3.9)
4741.3
(4452.2 to 5049.1)
Anti-HPV-18, sero-, Month 12 Number Analyzed 748 participants 901 participants
3.8
(3.7 to 3.9)
1521.7
(1431.0 to 1618.1)
Anti-HPV-18, sero-, Month 24 Number Analyzed 698 participants 854 participants
3.8
(3.7 to 3.9)
704.4
(658.4 to 753.8)
Anti-HPV-18, sero-, Month 36 Number Analyzed 691 participants 841 participants
3.7
(3.6 to 3.8)
534.3
(498.9 to 572.1)
Anti-HPV-18, sero-, Month 48 Number Analyzed 633 participants 806 participants
3.8
(3.7 to 3.9)
476.2
(443.2 to 511.6)
Anti-HPV-18, sero+, pre-vaccination Number Analyzed 108 participants 97 participants
23.4
(18.9 to 29.1)
24.8
(20.1 to 30.6)
Anti-HPV-18, sero+, Month 6 Number Analyzed 105 participants 97 participants
19.6
(15.2 to 25.4)
903.8
(714.0 to 1144.2)
Anti-HPV-18, sero+, Month 7 Number Analyzed 105 participants 97 participants
20.8
(16.2 to 26.8)
4135.7
(3548.6 to 4819.9)
Anti-HPV-18, sero+, Month 12 Number Analyzed 106 participants 92 participants
19.9
(15.5 to 25.5)
1509.5
(1271.3 to 1792.3)
Anti-HPV-18, sero+, Month 24 Number Analyzed 102 participants 89 participants
18.9
(14.6 to 24.4)
745.6
(620.1 to 896.6)
Anti-HPV-18, sero+, Month 36 Number Analyzed 98 participants 86 participants
16.8
(12.8 to 22.1)
580.9
(475.0 to 710.4)
Anti-HPV-18, sero+, Month 48 Number Analyzed 91 participants 86 participants
16.5
(12.6 to 21.6)
510.6
(415.7 to 627.2)
Anti-HPV-18, total, pre-vaccination Number Analyzed 898 participants 1036 participants
4.4
(4.2 to 4.6)
4.2
(4.0 to 4.4)
Anti-HPV-18, total, Month 6 Number Analyzed 876 participants 1027 participants
4.5
(4.3 to 4.8)
569.5
(536.0 to 605.1)
Anti-HPV-18, total, Month 7 Number Analyzed 877 participants 1027 participants
4.6
(4.4 to 4.9)
4680.5
(4413.4 to 4963.7)
Anti-HPV-18, total, Month 12 Number Analyzed 854 participants 993 participants
4.6
(4.4 to 4.9)
1520.5
(1435.0 to 1611.2)
Anti-HPV-18, total, Month 24 Number Analyzed 800 participants 943 participants
4.7
(4.4 to 4.9)
708.2
(664.6 to 754.8)
Anti-HPV-18, total, Month 36 Number Analyzed 789 participants 927 participants
4.5
(4.3 to 4.8)
538.5
(504.7 to 574.5)
Anti-HPV-18, total, Month 48 Number Analyzed 724 participants 892 participants
4.6
(4.3 to 4.8)
479.4
(448.0 to 513.0)
23.Secondary Outcome
Title HPV-16 and HPV-18 Seroconversion (V5/J4 Monoclonal Inhibition Test)
Hide Description

HPV-16 V5 cut-off was defined as greater than or equal to 41 ELU/mL. Only seronegative subjects were analysed. Seronegative subjects are subjects who had an antibody titer of less than 41 ELU/mL before vaccination.

HPV-18 J4 cut-off was defined as greater than or equal to 110 EL.U/mL. Both seropositive and seronegative subjects were included in the analysis. Seropositive subjects were subjects with an antibody titer of greater than or equal to 110 EL.U/mL. Seronegative subjects were subjects with an antibody titer less than 110 EL.U/mL.

Time Frame Month 0, 7, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyses was performed on the Total Vaccinated Cohort on subjects with available results.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
pre-vaccination V5 HPV-16 Number Analyzed 17 participants 17 participants
0
   0.0%
0
   0.0%
Month 7 V5 HPV-16 Number Analyzed 17 participants 17 participants
0
   0.0%
17
 100.0%
Month 12 V5 HPV-16 Number Analyzed 5 participants 2 participants
0
   0.0%
2
 100.0%
Month 24 V5 HPV-16 Number Analyzed 17 participants 17 participants
0
   0.0%
17
 100.0%
pre-vaccination J4 HPV-18 Number Analyzed 17 participants 17 participants
0
   0.0%
1
   5.9%
Month 7 J4 HPV-18 Number Analyzed 17 participants 17 participants
0
   0.0%
17
 100.0%
Month 12 J4 HPV-18 Number Analyzed 5 participants 2 participants
1
  20.0%
1
  50.0%
Month 24 V5 HPV-18 Number Analyzed 17 participants 17 participants
1
   5.9%
11
  64.7%
24.Secondary Outcome
Title HPV-16 and HPV-18 Geometric Mean Titers (GMT) (V5/J4 Monoclonal Inhibition Test)
Hide Description Titers were expressed as GMTs in ELISA units per milliliter (EL.U/mL).
Time Frame Month 0, 7, 12, 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses was performed on the Total Vaccinated cohort on subjects with available results.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 17 17
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
pre-vaccination V5 HPV-16 Number Analyzed 17 participants 17 participants
20.5
(20.5 to 20.5)
20.5
(20.5 to 20.5)
Month 7 V5 HPV-16 Number Analyzed 17 participants 17 participants
20.5
(20.5 to 20.5)
816.7
(472.5 to 1411.4)
Month 12 V5 HPV-16 Number Analyzed 5 participants 2 participants
20.5
(20.5 to 20.5)
173.5
(25.1 to 1199.3)
Month 24 V5 HPV-16 Number Analyzed 17 participants 17 participants
20.5
(20.5 to 20.5)
163.3
(104.0 to 256.6)
pre-vaccination J4 HPV-18 Number Analyzed 17 participants 17 participants
55.0
(55.0 to 55.0)
57.7
(52.1 to 63.8)
Month 7 J4 HPV-18 Number Analyzed 17 participants 17 participants
55.0
(55.0 to 55.0)
679.2
(423.6 to 1088.9)
Month 12 J4 HPV-18 Number Analyzed 5 participants 2 participants
71.0
(35.0 to 144.2)
83.6
(0.4 to 17024.0)
Month 24 V5 HPV-18 Number Analyzed 17 participants 17 participants
58.1
(51.7 to 65.2)
139.5
(90.5 to 215.1)
25.Secondary Outcome
Title Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)
Hide Description

Seropositivity was defined as subjects with a titer equal to or greater than 40.

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

Time Frame At Month 0, 7, 12, 24, 36 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the ATP cohort for immunogenicity which included subjects for whom immunogenicity data were available.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 47 48
Measure Type: Count of Participants
Unit of Measure: Participants
pre-vaccination HPV-16 Number Analyzed 44 participants 46 participants
0
   0.0%
0
   0.0%
Month 7 HPV-16 Number Analyzed 44 participants 46 participants
0
   0.0%
46
 100.0%
Month 12 HPV-16 Number Analyzed 43 participants 45 participants
0
   0.0%
45
 100.0%
Month 24 HPV-16 Number Analyzed 40 participants 46 participants
0
   0.0%
46
 100.0%
Month 36 HPV-16 Number Analyzed 33 participants 41 participants
0
   0.0%
41
 100.0%
Month 48 HPV-16 Number Analyzed 33 participants 41 participants
0
   0.0%
40
  97.6%
pre-vaccination HPV-18 Number Analyzed 47 participants 48 participants
0
   0.0%
0
   0.0%
Month 7 HPV-18 Number Analyzed 44 participants 46 participants
0
   0.0%
46
 100.0%
Month 12 HPV-18 Number Analyzed 43 participants 45 participants
0
   0.0%
44
  97.8%
Month 24 HPV-18 Number Analyzed 40 participants 46 participants
0
   0.0%
46
 100.0%
Month 36 HPV-18 Number Analyzed 33 participants 41 participants
0
   0.0%
41
 100.0%
Month 48 HPV-18 Number Analyzed 33 participants 41 participants
2
   6.1%
39
  95.1%
26.Secondary Outcome
Title Titers for Anti-HPV-16 and Anti-HPV-18 Antibodies Using Pseudovirion Based Neutralizing Assay (PBNA)
Hide Description Titers were expressed as GMTs.
Time Frame At month 0, 7, 12, 24, 36 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses were performed on the ATP cohort for immunogenicity for whom immunogenicity data were available.
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description:
Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
Overall Number of Participants Analyzed 47 48
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
pre-vaccination HPV-16 Number Analyzed 44 participants 46 participants
20.0
(20.0 to 20.0)
20.0
(20.0 to 20.0)
Month 7 HPV-16 Number Analyzed 44 participants 46 participants
20.0
(20.0 to 20.0)
27364.8
(19780.1 to 37857.9)
Month 12 HPV-16 Number Analyzed 43 participants 45 participants
20.0
(20.0 to 20.0)
8385.9
(5857.3 to 12006.0)
Month 24 HPV-16 Number Analyzed 40 participants 46 participants
20.0
(20.0 to 20.0)
3647.4
(2586.5 to 5143.4)
Month 36 HPV-16 Number Analyzed 33 participants 41 participants
20.0
(20.0 to 20.0)
2245.1
(1616.6 to 3117.9)
Month 48 HPV-16 Number Analyzed 33 participants 41 participants
20.0
(20.0 to 20.0)
1931.1
(1294.4 to 2880.8)
pre-vaccination HPV-18 Number Analyzed 47 participants 48 participants
20.0
(20.0 to 20.0)
20.0
(20.0 to 20.0)
Month 7 HPV-18 Number Analyzed 44 participants 46 participants
20.0
(20.0 to 20.0)
9052.7
(6851.8 to 11960.5)
Month 12 HPV-18 Number Analyzed 43 participants 45 participants
20.0
(20.0 to 20.0)
1889.9
(1316.0 to 2714.1)
Month 24 HPV-18 Number Analyzed 40 participants 46 participants
20.0
(20.0 to 20.0)
1695.6
(1200.7 to 2394.4)
Month 36 HPV-18 Number Analyzed 33 participants 41 participants
20.0
(20.0 to 20.0)
1326.9
(948.0 to 1857.3)
Month 48 HPV-18 Number Analyzed 33 participants 41 participants
23.8
(18.6 to 30.4)
1078.1
(714.9 to 1625.6)
27.Secondary Outcome
Title Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 6-month Persistent Infection
Hide Description GMT for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.
Time Frame At Month 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.
Arm/Group Title Cervarix Group Without HPV-16 6-Month Persistent Infection Cervarix Group With HPV-16 6-Month Persistent Infection
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 6-Month persistent infection with HPV-16.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 6-Month persistent infection with HPV-16.
Overall Number of Participants Analyzed 1123 45
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
7667.34
(7212.13 to 8151.29)
6986.30
(5692.83 to 8573.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cervarix Group Without HPV-16 6-Month Persistent Infection, Cervarix Group With HPV-16 6-Month Persistent Infection
Comments Hazard ratio of anti-HPV-16 GMTs at Month 7 (by ELISA) in subjects without 6-month persistent infection compared to subjects with 6-month persistent infection
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3910
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.798
Confidence Interval (2-Sided) 95%
0.476 to 1.337
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Number of Seroconverted Subjects for Anti-HPV-16 Without and With 6-month Persistent Infection.
Hide Description Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence interval) was not calculated.
Time Frame At Month 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.
Arm/Group Title Cervarix Group Without HPV-16 6-Month Persistent Infection Cervarix Group With HPV-16 6-Month Persistent Infection
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 6-Month persistent infection with HPV-16.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 6-Month persistent infection with HPV-16.
Overall Number of Participants Analyzed 1123 45
Measure Type: Count of Participants
Unit of Measure: Participants
1118
  99.6%
45
 100.0%
29.Secondary Outcome
Title Geometric Mean Titers of Anti-HPV-16 in Subjects Without and With 12-month Persistent Infection
Hide Description GMTs for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.
Time Frame At Month 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.
Arm/Group Title Cervarix Group Without HPV-16 12-Month Persistent Infection Cervarix Group With HPV-16 12-Month Persistent Infection
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, without 12 Month persistent infection with HPV-16.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, with 12 Month persistent infection with HPV-16.
Overall Number of Participants Analyzed 1120 37
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
7683.56
(7229.22 to 8166.44)
6839.71
(5362.44 to 8723.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cervarix Group Without HPV-16 12-Month Persistent Infection
Comments Hazard ratio of anti-HPV-16 GMTs at Month 7 (by ELISA) in subjects without 12-month persistent infection compared to subjects with 12-month persistent infection.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3796
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.778
Confidence Interval (2-Sided) 95%
0.444 to 1.362
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Number of Seroconverted Subjects for Anti-HPV-16 Without and With 12-month Persistent Infection
Hide Description Seroconversion rates for anti-HPV-16 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.
Time Frame At Month 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-16 DNA negative and seronegative at baseline.
Arm/Group Title Cervarix Group Without HPV-16 12-Month Persistent Infection Cervarix Group With HPV-16 12-Month Persistent Infection
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, without 12 Month persistent infection with HPV-16.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, with 12 Month persistent infection with HPV-16.
Overall Number of Participants Analyzed 1120 37
Measure Type: Count of Participants
Unit of Measure: Participants
1115
  99.6%
37
 100.0%
31.Secondary Outcome
Title Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 6-month Persistent Infection
Hide Description GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.
Time Frame At Month 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.
Arm/Group Title Cervarix Group Without HPV-18 6-Month Persistent Infection Cervarix Group With HPV-18 6-Month Persistent Infection
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 6-Month persistent infection with HPV-18.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 6-Month persistent infection with HPV-18.
Overall Number of Participants Analyzed 1248 28
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
3963.50
(3750.71 to 4188.37)
2945.69
(2271.74 to 3819.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cervarix Group Without HPV-18 6-Month Persistent Infection, Cervarix Group With HPV-18 6-Month Persistent Infection
Comments Hazard ratio of anti-HPV-18 GMTs at Month 7 (by ELISA) in subjects without 6-month persistent infection compared to subjects with 6-month persistent infection.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1035
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.610
Confidence Interval 95%
0.337 to 1.106
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Number of Seroconverted Subjects for Anti-HPV-18 Without and With 6-month Persistent Infection.
Hide Description Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 6-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.
Time Frame At Month 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.
Arm/Group Title Cervarix Group Without HPV-18 6-Month Persistent Infection Cervarix Group With HPV-18 6-Month Persistent Infection
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 6-Month persistent infection with HPV-18.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 6-Month persistent infection with HPV-18.
Overall Number of Participants Analyzed 1248 28
Measure Type: Count of Participants
Unit of Measure: Participants
1242
  99.5%
28
 100.0%
33.Secondary Outcome
Title Geometric Mean Titers of Anti-HPV-18 in Subjects Without and With 12-month Persistent Infection
Hide Description GMTs for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections.
Time Frame At Month 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.
Arm/Group Title Cervarix Group Without HPV-18 12-Month Persistent Infection Cervarix Group With HPV-18 12-Month Persistent Infection
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 12-Month persistent infection with HPV-18.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 12-Month persistent infection with HPV-18.
Overall Number of Participants Analyzed 1243 21
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
3965.67
(3753.09 to 4190.29)
3063.23
(2261.65 to 4148.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cervarix Group Without HPV-18 12-Month Persistent Infection, Cervarix Group With HPV-18 12-Month Persistent Infection
Comments Hazard ratio of anti-HPV-18 GMTs at Month 7 (by ELISA) in subjects without 12-month persistent infection compared to subjects with 12-month persistent infection.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2111
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.635
Confidence Interval (2-Sided) 95%
0.312 to 1.293
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Number of Seroconverted Subjects for Anti-HPV-18 Without and With 12-month Persistent Infection
Hide Description Seroconversion rates for anti-HPV-18 antibodies by ELISA in subjects with breakthrough persistent infections 12-month definition, were compared to those in a matched set of subjects without breakthrough persistent infections. Due to the lack of seronegative subjects at Month 7, the hazard ratio (and Confidence Interval) was not calculated.
Time Frame At Month 7
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Hide Analysis Population Description
The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available, only on subjects HPV-18 DNA negative and seronegative at baseline.
Arm/Group Title Cervarix Group Without HPV-18 12-Month Persistent Infection Cervarix Group With HPV-18 12-Month Persistent Infection
Hide Arm/Group Description:
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6 and who did not present 12-Month persistent infection with HPV-18.
Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6, who presented 12-Month persistent infection with HPV-18.
Overall Number of Participants Analyzed 1243 21
Measure Type: Count of Participants
Unit of Measure: Participants
1237
  99.5%
21
 100.0%
Time Frame Solicited symptoms during the 7-day post-vaccination period, Unsolicited AEs during the 30-day post-vaccination period, SAEs during the entire FU period.
Adverse Event Reporting Description 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.
 
Arm/Group Title Havrix Group Cervarix Group
Hide Arm/Group Description Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6. Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
All-Cause Mortality
Havrix Group Cervarix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Havrix Group Cervarix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   829/9325 (8.89%)   835/9319 (8.96%) 
Blood and lymphatic system disorders     
Anaemia * 1  3/9325 (0.03%)  1/9319 (0.01%) 
Lymphadenitis * 1  1/9325 (0.01%)  3/9319 (0.03%) 
Thrombocytopenia * 1  1/9325 (0.01%)  1/9319 (0.01%) 
Hyperchromic anaemia * 1  0/9325 (0.00%)  1/9319 (0.01%) 
Idiopathic thrombocytopenic purpura * 1  0/9325 (0.00%)  1/9319 (0.01%) 
Iron deficiency anaemia * 1  1/9325 (0.01%)  0/9319 (0.00%) 
Cardiac disorders     
Sinus tachycardia * 1  1/9325 (0.01%)  2/9319 (0.02%) 
Supraventricular tachycardia * 1  1/9325 (0.01%)  2/9319 (0.02%) 
Arrhythmia * 1  0/9325 (0.00%)  2/9319 (0.02%) 
Cardio-respiratory arrest * 1  2/9325 (0.02%)  0/9319 (0.00%) 
Atrial fibrillation * 1  0/9325 (0.00%)  1/9319 (0.01%) 
Atrial flutter * 1  0/9325 (0.00%)  1/9319 (0.01%) 
Cardiopulmonary failure * 1  0/9325 (0.00%)  1/9319 (0.01%) 
Myocarditis * 1  1/9325 (0.01%)  0/9319 (0.00%) 
Pericarditis * 1  1/9325 (0.01%)  0/9319 (0.00%) 
Tachycardia * 1  0/9325 (0.00%)  1/9319 (0.01%) 
Ventricular arrhythmia * 1  0/9325 (0.00%)  1/9319 (0.01%) 
Wolff-parkinson-white syndrome * 1  1/9325 (0.01%)  0/9319 (0.00%) 
Congenital, familial and genetic disorders     
Coarctation of the aorta * 1  1/9325 (0.01%)  0/9319 (0.00%) 
Dermoid cyst * 1  1/9325 (0.01%)  0/9319 (0.00%) 
Thyroglossal cyst * 1  1/9325 (0.01%)  0/9319 (0.00%) 
Ventricular septal defect * 1  1/9325 (0.01%)  0/9319 (0.00%) 
Ear and labyrinth disorders     
Deafness * 1  0/9325 (0.00%)  1/9319 (0.01%) 
Deafness bilateral * 1  1/9325 (0.01%)  0/9319 (0.00%) 
Meniere's disease * 1  1/9325 (0.01%)  0/9319 (0.00%) 
Tympanic membrane perforation * 1  1/9325 (0.01%)  0/9319 (0.00%) 
Vertigo * 1  0/9325 (0.00%)  1/9319 (0.01%) 
Endocrine disorders     
Goitre * 1  1/9325 (0.01%)  1/9319 (0.01%) 
Autoimmune thyroiditis * 1  0/9325 (0.00%)  1/9319 (0.01%) 
Basedow’s disease * 1  0/9325 (0.00%)  1/9319 (0.01%) 
Eye disorders     
Blindness unilateral * 1  0/9325 (0.00%)  1/9319 (0.01%) 
Conjunctivitis * 1  0/9325 (0.00%)  1/9319 (0.01%) 
Dacryostenosis acquired * 1  0/9325 (0.00%)  1/9319 (0.01%) 
Retinal detachment * 1  1/9325 (0.01%)  0/9319 (0.00%) 
Strabismus * 1  1/9325 (0.01%)  0/9319 (0.00%) 
Vision blurred * 1  0/9325 (0.00%)  1/9319 (0.01%) 
Gastrointestinal disorders     
Abdominal pain * 1  15/9325 (0.16%)  16/9319 (0.17%) 
Gastritis * 1  4/9325 (0.04%)  9/9319 (0.10%) 
Abdominal pain lower * 1  4/9325 (0.04%)  4/9319 (0.04%)