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Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00534638
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : January 26, 2016
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Interventions Biological: Cervarix
Biological: Engerix-B
Enrollment 34412
Recruitment Details Immunization phase (Day 0 to Month 12) = adolescents (birth cohorts ‘92-‘95) were vaccinated with Cervarix/Engerix-B. Effectiveness evaluation phase (Visit 5) = the vaccine’s impact was assessed on female subjects aged 18.5. At Day 0, Cervarix was not licensed for males;male subjects receiving the vaccine were considered part of a Phase III trial.
Pre-assignment Details 34412 subjects were enrolled in the study, out of which 2236 subjects had a subject number allocated, but did not receive a vaccine dose, and 1 subject was excluded due to non-eligibility criteria, hence 32175 subjects were vaccinated and started the study.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Period Title: Overall Study
Started 14837 17338
Completed 8346 5547
Not Completed 6491 11791
Reason Not Completed
Withdrawal by Subject             3             4
Migrated/moved from study area             13             11
Lost to follow-up,incomplete vaccination             83             117
Lost to follow-up, complete vaccination             4707             10757
Other             1685             902
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group Total
Hide Arm/Group Description Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. Total of all reporting groups
Overall Number of Baseline Participants 14837 17338 32175
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14837 participants 17338 participants 32175 participants
14.1  (0.8) 14.1  (0.8) 14.1  (0.8)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14837 participants 17338 participants 32175 participants
Female
12399
  83.6%
8119
  46.8%
20518
  63.8%
Male
2438
  16.4%
9219
  53.2%
11657
  36.2%
[1]
Measure Description:

After the database freeze, discrepancies in the gender of 10 subjects were detected, this leading to 12401 female and 2436 male subjects in the Cervarix Pooled Group, and 8111 female and 9227 male subjects in the Engerix-B Pooled Group.

These 10 subjects were not part of the Immunogenicity subset, the Diary Card subset or included in the active safety follow-up up to Month 12 for SAEs.

These 10 subjects did not report any AEs and did not have any sample results. The impact on the AEs and overall effectiveness analysis was limited to the number of subjects exposed and considered minor.

Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Geographic ancestry Number Analyzed 14837 participants 17338 participants 32175 participants
African heritage/African American
9
   0.1%
8
   0.0%
17
   0.1%
Asian - Central/South Asian heritage
3
   0.0%
4
   0.0%
7
   0.0%
Asian - East Asian heritage
8
   0.1%
0
   0.0%
8
   0.0%
Asian - Japanese heritage
1
   0.0%
1
   0.0%
2
   0.0%
Asian - South East Asian heritage
13
   0.1%
4
   0.0%
17
   0.1%
White - Arabic/North African heritage
31
   0.2%
39
   0.2%
70
   0.2%
White - Caucasian/European heritage
14669
  98.9%
17190
  99.1%
31859
  99.0%
Mixed origin
103
   0.7%
92
   0.5%
195
   0.6%
1.Primary Outcome
Title Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group
Hide Description The analysis of overall effectiveness of Cervarix vaccine against genital infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The overall vaccine effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).
Time Frame At the time of Visit 5 (i.e. at 18.5 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.
Arm/Group Title Cervarix/Engerix-B A Group Cervarix/Engerix-B B Group Engerix-B Group
Hide Arm/Group Description:
The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 3629 4029 3168
Measure Type: Count of Participants
Unit of Measure: Participants
139
   3.8%
117
   2.9%
329
  10.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cervarix/Engerix-B B Group, Engerix-B Group
Comments Overall efectiveness against HPV-16/18 Cervarix/Engerix-B B Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK’s HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B B Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments An objective was reached if the 2-sided p-value associated to the objective was below 5%.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine effectiveness percentage
Estimated Value 49.6
Confidence Interval (2-Sided) 95%
20.1 to 68.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cervarix/Engerix-B A Group, Engerix-B Group
Comments Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK’s HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.232
Comments An objective was reached if the 2-sided p-value associated to the objective was below 5%.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine effectiveness percentage
Estimated Value 23.8
Confidence Interval (2-Sided) 95%
-19.0 to 51.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group
Hide Description

The analysis of overall effectiveness of Cervarix vaccine against genital infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The overall vaccine effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the Cervarix/Engerix-B A Group/prevalence rate in all subjects from Engerix-B Group).

Note: As per Protocol and as the confirmatory objectives were not met, only exploratory interpretation could be performed for what concerns this secondary outcome measure.

Time Frame At the time of Visit 5 (i.e. at 18.5 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.
Arm/Group Title Cervarix/Engerix-B A Group Cervarix/Engerix-B B Group
Hide Arm/Group Description:
The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 3629 4029
Measure Type: Count of Participants
Unit of Measure: Participants
139
   3.8%
117
   2.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cervarix/Engerix-B A Group, Cervarix/Engerix-B B Group
Comments Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Cervarix/Engerix-B B Group: The analysis of the overall effectiveness of GSK’s HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Cervarix/Engerix-B B was based on stratified Mantel-Haenszel adjusted for clustering.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments An objective was reached if the 2-sided p-value associated to the objective was below 5%.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine effectiveness percentage
Estimated Value -52.2
Confidence Interval (2-Sided) 95%
-139.4 to 3.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types
Hide Description The analysis of overall effectiveness of Cervarix vaccine against genital infection with specific HPV types (16, 18, 31/45, 31/33/45, 31/33/45/51, 31/33/45/51/52, 31/33/35/39/45/51/52/56/58/59/66/68, 16/18/31/33/35/39/45/51/52/56/58/59/66/68, 6, 11, 6/11, 6/11/53/74) was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).
Time Frame At the time of Visit 5 (i.e. at 18.5 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.
Arm/Group Title Cervarix/Engerix-B A Group Cervarix/Engerix-B B Group Engerix-B Group
Hide Arm/Group Description:
The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 3629 4029 3168
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16
88
   2.4%
85
   2.1%
227
   7.2%
HPV-18
62
   1.7%
41
   1.0%
134
   4.2%
HPV-31/45
97
   2.7%
93
   2.3%
182
   5.7%
HPV-31/33/45
175
   4.8%
173
   4.3%
271
   8.6%
HPV-31/33/45/51
449
  12.4%
450
  11.2%
441
  13.9%
HPV-31/33/45/51/52
563
  15.5%
585
  14.5%
532
  16.8%
HPV-31/33/35/39/45/51/52/56/58/59/66/68
923
  25.4%
961
  23.9%
776
  24.5%
HPV-16/18/31/33/35/39/45/51/52/56/58/59/66/68
965
  26.6%
999
  24.8%
883
  27.9%
HPV-6
192
   5.3%
183
   4.5%
139
   4.4%
HPV-11
39
   1.1%
32
   0.8%
34
   1.1%
HPV-6/11
221
   6.1%
204
   5.1%
165
   5.2%
HPV-6/11/53/74
403
  11.1%
381
   9.5%
307
   9.7%
4.Secondary Outcome
Title Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types
Hide Description The analysis of total effectiveness of Cervarix vaccine against oropharyngeal infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in Cervarix vaccinated subjects from the investigated group (prevalence rate in Cervarix vaccinated subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).
Time Frame At the time of Visit 5 (i.e. at 18.5 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.
Arm/Group Title Cervarix/Engerix-B Pooled Group Engerix-B Group
Hide Arm/Group Description:
Pooled A and B group: This pooled group includes subjects from communities where 70% of male and female adolescents (A group) or 70% of female adolescents (B group) were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants (A group) or female participants (B group) to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects (A group) or vaccinated females (B group) were randomized to Cervarix). Finally, subjects from this pooled group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 3192 1679
Measure Type: Count of Participants
Unit of Measure: Participants
9
   0.3%
27
   1.6%
5.Secondary Outcome
Title Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types
Hide Description The analysis of total effectiveness of Cervarix vaccine against oropharyngeal infection with specific HPV types (16, 18, 31/45, 31/33/45, 31/33/45/51, 31/33/45/51/52, 31/33/35/39/45/51/52/56/58/59/66/68, 16/18/31/33/35/39/45/51/52/56/58/59/66/68, 6, 11, 6/11, 6/11/53/74) was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all Cervarix vaccinated subjects from the investigated group (prevalence rate in all Cervarix vaccinated subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).
Time Frame At the time of Visit 5 (at 18.5 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.
Arm/Group Title Cervarix/Engerix-B Pooled Group Engerix-B Group
Hide Arm/Group Description:
Pooled A and B group: This pooled group includes subjects from communities where 70% of male and female adolescents (A group) or 70% of female adolescents (B group) were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants (A group) or female participants (B group) to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects (A group) or vaccinated females (B group) were randomized to Cervarix). Finally, subjects from this pooled group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 3192 1679
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16
6
   0.2%
19
   1.1%
HPV-18
4
   0.1%
10
   0.6%
HPV-31/45
3
   0.1%
9
   0.5%
HPV-31/33/45
9
   0.3%
16
   1.0%
HPV-31/33/45/51
53
   1.7%
42
   2.5%
HPV-31/33/45/51/52
63
   2.0%
49
   2.9%
HPV-31/33/35/39/45/51/52/56/58/59/66/68
129
   4.0%
79
   4.7%
HPV-16/18/31/33/35/39/45/51/52/56/58/59/66/68
136
   4.3%
95
   5.7%
HPV-6
36
   1.1%
27
   1.6%
HPV-11
5
   0.2%
5
   0.3%
HPV-6/11
41
   1.3%
29
   1.7%
HPV-6/11/53/74
72
   2.3%
45
   2.7%
6.Secondary Outcome
Title Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time Frame During the 7-day post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total vaccinated cohort (TVC) - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group, with at least one study vaccine administration documented, who were selected for active assessment of safety using diary cards and for whom data were available.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 603 1028
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 590 participants 1021 participants
463
  78.5%
157
  15.4%
Grade 3 Pain, Dose 1 Number Analyzed 590 participants 1021 participants
12
   2.0%
1
   0.1%
Any Redness, Dose 1 Number Analyzed 590 participants 1021 participants
99
  16.8%
90
   8.8%
Grade 3 Redness, Dose 1 Number Analyzed 590 participants 1021 participants
1
   0.2%
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 590 participants 1021 participants
61
  10.3%
29
   2.8%
Grade 3 Swelling, Dose 1 Number Analyzed 590 participants 1021 participants
4
   0.7%
0
   0.0%
Any Pain, Dose 2 Number Analyzed 509 participants 935 participants
331
  65.0%
123
  13.2%
Grade 3 Pain, Dose 2 Number Analyzed 509 participants 935 participants
9
   1.8%
1
   0.1%
Any Redness, Dose 2 Number Analyzed 509 participants 935 participants
88
  17.3%
59
   6.3%
Grade 3 Redness, Dose 2 Number Analyzed 509 participants 935 participants
1
   0.2%
0
   0.0%
Any Swelling, Dose 2 Number Analyzed 509 participants 935 participants
66
  13.0%
16
   1.7%
Grade 3 Swelling, Dose 2 Number Analyzed 509 participants 935 participants
3
   0.6%
0
   0.0%
Any Pain, Dose 3 Number Analyzed 491 participants 812 participants
326
  66.4%
108
  13.3%
Grade 3 Pain, Dose 3 Number Analyzed 491 participants 812 participants
11
   2.2%
0
   0.0%
Any Redness, Dose 3 Number Analyzed 491 participants 812 participants
100
  20.4%
50
   6.2%
Grade 3 Redness, Dose 3 Number Analyzed 491 participants 812 participants
2
   0.4%
0
   0.0%
Any Swelling, Dose 3 Number Analyzed 491 participants 812 participants
69
  14.1%
18
   2.2%
Grade 3 Swelling, Dose 3 Number Analyzed 491 participants 812 participants
3
   0.6%
0
   0.0%
Any Pain, Across doses Number Analyzed 603 participants 1028 participants
506
  83.9%
251
  24.4%
Grade 3 Pain, Across doses Number Analyzed 603 participants 1028 participants
26
   4.3%
2
   0.2%
Any Redness, Across doses Number Analyzed 603 participants 1028 participants
169
  28.0%
131
  12.7%
Grade 3 Redness, Across doses Number Analyzed 603 participants 1028 participants
4
   0.7%
0
   0.0%
Any Swelling, Across doses Number Analyzed 603 participants 1028 participants
131
  21.7%
46
   4.5%
Grade 3 Swelling, Across doses Number Analyzed 603 participants 1028 participants
8
   1.3%
0
   0.0%
7.Secondary Outcome
Title Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects
Hide Description Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 7-day post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the TVC - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group, with at least one study vaccine administration documented, who were selected for active assessment of safety using diary cards and for whom data were available.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 604 1028
Measure Type: Count of Participants
Unit of Measure: Participants
Any Arthralgia, Dose 1 Number Analyzed 590 participants 1021 participants
58
   9.8%
58
   5.7%
Grade 3 Arthralgia, Dose 1 Number Analyzed 590 participants 1021 participants
0
   0.0%
1
   0.1%
Related Arthralgia, Dose 1 Number Analyzed 590 participants 1021 participants
37
   6.3%
45
   4.4%
Any Fatigue, Dose 1 Number Analyzed 590 participants 1021 participants
224
  38.0%
301
  29.5%
Grade 3 Fatigue, Dose 1 Number Analyzed 590 participants 1021 participants
3
   0.5%
9
   0.9%
Related Fatigue, Dose 1 Number Analyzed 590 participants 1021 participants
156
  26.4%
246
  24.1%
Any Fever (axillary), Dose 1 Number Analyzed 590 participants 1021 participants
15
   2.5%
35
   3.4%
Grade 3 Fever (axillary), Dose 1 Number Analyzed 590 participants 1021 participants
3
   0.5%
4
   0.4%
Related Fever (axillary), Dose 1 Number Analyzed 590 participants 1021 participants
7
   1.2%
23
   2.3%
Any Gastrointestinal, Dose 1 Number Analyzed 590 participants 1021 participants
73
  12.4%
101
   9.9%
Grade 3 Gastrointestinal, Dose 1 Number Analyzed 590 participants 1021 participants
7
   1.2%
6
   0.6%
Related Gastrointestinal, Dose 1 Number Analyzed 590 participants 1021 participants
45
   7.6%
84
   8.2%
Any Headache, Dose 1 Number Analyzed 590 participants 1021 participants
178
  30.2%
255
  25.0%
Grade 3 Headache, Dose 1 Number Analyzed 590 participants 1021 participants
10
   1.7%
7
   0.7%
Related Headache, Dose 1 Number Analyzed 590 participants 1021 participants
108
  18.3%
181
  17.7%
Any Myalgia, Dose 1 Number Analyzed 590 participants 1021 participants
229
  38.8%
169
  16.6%
Grade 3 Myalgia, Dose 1 Number Analyzed 590 participants 1021 participants
6
   1.0%
2
   0.2%
Related Myalgia, Dose 1 Number Analyzed 590 participants 1021 participants
196
  33.2%
138
  13.5%
Any Rash, Dose 1 Number Analyzed 590 participants 1021 participants
13
   2.2%
17
   1.7%
Grade 3 Rash, Dose 1 Number Analyzed 590 participants 1021 participants
0
   0.0%
0
   0.0%
Related Rash, Dose 1 Number Analyzed 590 participants 1021 participants
5
   0.8%
12
   1.2%
Any Urticaria, Dose 1 Number Analyzed 590 participants 1021 participants
3
   0.5%
12
   1.2%
Grade 3 Urticaria, Dose 1 Number Analyzed 590 participants 1021 participants
0
   0.0%
0
   0.0%
Related Urticaria, Dose 1 Number Analyzed 590 participants 1021 participants
2
   0.3%
11
   1.1%
Any Arthralgia, Dose 2 Number Analyzed 511 participants 936 participants
41
   8.0%
38
   4.1%
Grade 3 Arthralgia, Dose 2 Number Analyzed 511 participants 936 participants
0
   0.0%
3
   0.3%
Related Arthralgia, Dose 2 Number Analyzed 511 participants 936 participants
36
   7.0%
33
   3.5%
Any Fatigue, Dose 2 Number Analyzed 511 participants 936 participants
136
  26.6%
155
  16.6%
Grade 3 Fatigue, Dose 2 Number Analyzed 511 participants 936 participants
2
   0.4%
7
   0.7%
Related Fatigue, Dose 2 Number Analyzed 511 participants 936 participants
100
  19.6%
123
  13.1%
Any Fever, Dose 2 Number Analyzed 511 participants 936 participants
19
   3.7%
28
   3.0%
Grade 3 Fever, Dose 2 Number Analyzed 511 participants 936 participants
1
   0.2%
2
   0.2%
Related Fever, Dose 2 Number Analyzed 511 participants 936 participants
11
   2.2%
10
   1.1%
Any Gastrointestinal, Dose 2 Number Analyzed 511 participants 936 participants
45
   8.8%
50
   5.3%
Grade 3 Gastrointestinal, Dose 2 Number Analyzed 511 participants 936 participants
4
   0.8%
5
   0.5%
Related Gastrointestinal, Dose 2 Number Analyzed 511 participants 936 participants
27
   5.3%
38
   4.1%
Any Headache, Dose 2 Number Analyzed 511 participants 936 participants
101
  19.8%
144
  15.4%
Grade 3 Headache, Dose 2 Number Analyzed 511 participants 936 participants
5
   1.0%
4
   0.4%
Related Headache, Dose 2 Number Analyzed 511 participants 936 participants
55
  10.8%
104
  11.1%
Any Myalgia, Dose 2 Number Analyzed 511 participants 936 participants
151
  29.5%
97
  10.4%
Grade 3 Myalgia, Dose 2 Number Analyzed 511 participants 936 participants
1
   0.2%
1
   0.1%
Related Myalgia, Dose 2 Number Analyzed 511 participants 936 participants
143
  28.0%
77
   8.2%
Any Rash, Dose 2 Number Analyzed 511 participants 936 participants
9
   1.8%
14
   1.5%
Grade 3 Rash, Dose 2 Number Analyzed 511 participants 936 participants
0
   0.0%
0
   0.0%
Related Rash, Dose 2 Number Analyzed 511 participants 936 participants
4
   0.8%
9
   1.0%
Any Urticaria, Dose 2 Number Analyzed 511 participants 936 participants
1
   0.2%
2
   0.2%
Grade 3 Urticaria, Dose 2 Number Analyzed 511 participants 936 participants
0
   0.0%
0
   0.0%
Related Urticaria, Dose 2 Number Analyzed 511 participants 936 participants
1
   0.2%
1
   0.1%
Any Arthralgia, Dose 3 Number Analyzed 492 participants 814 participants
53
  10.8%
33
   4.1%
Grade 3 Arthralgia, Dose 3 Number Analyzed 492 participants 814 participants
1
   0.2%
0
   0.0%
Related Arthralgia, Dose 3 Number Analyzed 492 participants 814 participants
41
   8.3%
29
   3.6%
Any Fatigue, Dose 3 Number Analyzed 492 participants 814 participants
135
  27.4%
141
  17.3%
Grade 3 Fatigue, Dose 3 Number Analyzed 492 participants 814 participants
4
   0.8%
6
   0.7%
Related Fatigue, Dose 3 Number Analyzed 492 participants 814 participants
100
  20.3%
116
  14.3%
Any Fever, Dose 3 Number Analyzed 492 participants 814 participants
15
   3.0%
27
   3.3%
Grade 3 Fever, Dose 3 Number Analyzed 492 participants 814 participants
2
   0.4%
3
   0.4%
Related Fever, Dose 3 Number Analyzed 492 participants 814 participants
10
   2.0%
24
   2.9%
Any Gastrointestinal, Dose 3 Number Analyzed 492 participants 814 participants
19
   3.9%
50
   6.1%
Grade 3 Gastrointestinal, Dose 3 Number Analyzed 492 participants 814 participants
0
   0.0%
2
   0.2%
Related Gastrointestinal, Dose 3 Number Analyzed 492 participants 814 participants
12
   2.4%
39
   4.8%
Any Headache, Dose 3 Number Analyzed 492 participants 814 participants
101
  20.5%
123
  15.1%
Grade 3 Headache, Dose 3 Number Analyzed 492 participants 814 participants
2
   0.4%
3
   0.4%
Related Headache, Dose 3 Number Analyzed 492 participants 814 participants
69
  14.0%
97
  11.9%
Any Myalgia, Dose 3 Number Analyzed 492 participants 814 participants
158
  32.1%
80
   9.8%
Grade 3 Myalgia, Dose 3 Number Analyzed 492 participants 814 participants
5
   1.0%
0
   0.0%
Related Myalgia, Dose 3 Number Analyzed 492 participants 814 participants
137
  27.8%
69
   8.5%
Any Rash, Dose 3 Number Analyzed 492 participants 814 participants
11
   2.2%
9
   1.1%
Grade 3 Rash, Dose 3 Number Analyzed 492 participants 814 participants
0
   0.0%
0
   0.0%
Related Rash, Dose 3 Number Analyzed 492 participants 814 participants
5
   1.0%
8
   1.0%
Any Urticaria, Dose 3 Number Analyzed 492 participants 814 participants
0
   0.0%
3
   0.4%
Grade 3 Urticaria, Dose 3 Number Analyzed 492 participants 814 participants
0
   0.0%
0
   0.0%
Related Urticaria, Dose 3 Number Analyzed 492 participants 814 participants
0
   0.0%
3
   0.4%
Any Arthralgia, Across doses Number Analyzed 604 participants 1028 participants
107
  17.7%
97
   9.4%
Grade 3 Arthralgia, Across doses Number Analyzed 604 participants 1028 participants
1
   0.2%
4
   0.4%
Related Arthralgia, Across doses Number Analyzed 604 participants 1028 participants
87
  14.4%
81
   7.9%
Any Fatigue, Across doses Number Analyzed 604 participants 1028 participants
291
  48.2%
411
  40.0%
Grade 3 Fatigue, Across doses Number Analyzed 604 participants 1028 participants
7
   1.2%
21
   2.0%
Related Fatigue, Across doses Number Analyzed 604 participants 1028 participants
233
  38.6%
351
  34.1%
Any Fever, Across doses Number Analyzed 604 participants 1028 participants
48
   7.9%
85
   8.3%
Grade 3 Fever, Across doses Number Analyzed 604 participants 1028 participants
6
   1.0%
9
   0.9%
Related Fever, Across doses Number Analyzed 604 participants 1028 participants
28
   4.6%
53
   5.2%
Any Gastrointestinal, Across doses Number Analyzed 604 participants 1028 participants
106
  17.5%
163
  15.9%
Grade 3 Gastrointestinal, Across doses Number Analyzed 604 participants 1028 participants
11
   1.8%
13
   1.3%
Related Gastrointestinal, Across doses Number Analyzed 604 participants 1028 participants
70
  11.6%
128
  12.5%
Any Headache, Across doses Number Analyzed 604 participants 1028 participants
261
  43.2%
371
  36.1%
Grade 3 Headache, Across doses Number Analyzed 604 participants 1028 participants
15
   2.5%
14
   1.4%
Related Headache, Across doses Number Analyzed 604 participants 1028 participants
176
  29.1%
280
  27.2%
Any Myalgia, Across doses Number Analyzed 604 participants 1028 participants
321
  53.1%
250
  24.3%
Grade 3 Myalgia, Across doses Number Analyzed 604 participants 1028 participants
12
   2.0%
3
   0.3%
Related Myalgia, Across doses Number Analyzed 604 participants 1028 participants
291
  48.2%
211
  20.5%
Any Rash, Across doses Number Analyzed 604 participants 1028 participants
29
   4.8%
33
   3.2%
Grade 3 Rash, Across doses Number Analyzed 604 participants 1028 participants
0
   0.0%
0
   0.0%
Related Rash, Across doses Number Analyzed 604 participants 1028 participants
14
   2.3%
23
   2.2%
Any Urticaria, Across doses Number Analyzed 604 participants 1028 participants
4
   0.7%
15
   1.5%
Grade 3 Urticaria, Across doses Number Analyzed 604 participants 1028 participants
0
   0.0%
0
   0.0%
Related Urticaria, Across doses Number Analyzed 604 participants 1028 participants
3
   0.5%
13
   1.3%
8.Secondary Outcome
Title Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame Within the 30-day post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 643 1047
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
157
  24.4%
202
  19.3%
Grade 3 AEs
31
   4.8%
46
   4.4%
Related AEs
12
   1.9%
19
   1.8%
9.Secondary Outcome
Title Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects
Hide Description The number of subjects with urticaria/rash assessed within 30 minutes following each vaccine dose are reported. Confirmed urticaria/rash = subjects who reported urticaria/rash within the specified time frame. Not confirmed urticaria/rash = number of subjects who did not report urticaria/rash within the specified time frame.
Time Frame Within 30 minutes following each vaccination dose
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 643 1047
Measure Type: Count of Participants
Unit of Measure: Participants
Not confirmed urticaria/rash, Dose 1 Number Analyzed 643 participants 1047 participants
643
 100.0%
1047
 100.0%
Confirmed urticaria/rash, Dose 1 Number Analyzed 643 participants 1047 participants
0
   0.0%
0
   0.0%
Not confirmed urticaria/rash, Dose 2 Number Analyzed 634 participants 1042 participants
634
 100.0%
1042
 100.0%
Confirmed urticaria/rash, Dose 2 Number Analyzed 634 participants 1042 participants
0
   0.0%
0
   0.0%
Not confirmed urticaria/rash, Dose 3 Number Analyzed 631 participants 1039 participants
630
  99.8%
1039
 100.0%
Confirmed urticaria/rash, Dose 3 Number Analyzed 631 participants 1039 participants
0
   0.0%
0
   0.0%
Missing urticaria/rash, Dose 3 Number Analyzed 631 participants 1039 participants
1
   0.2%
0
   0.0%
10.Secondary Outcome
Title Number of Male Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects
Hide Description MSCs are defined as AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.
Time Frame From Dose 1 (at Day 0) until Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 643 1047
Measure Type: Count of Participants
Unit of Measure: Participants
47
   7.3%
76
   7.3%
11.Secondary Outcome
Title Number of Male Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time Frame From Dose 1 (at Day 0) until Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the TVC - subset of male subjects with active follow-up Month 0-Month 12 for SAEs, which included the male subjects in the Diary Card subset and the remaining Cervarix/Engerix-B A Group male subjects for whom data were available.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 2436 1267
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAEs
58
   2.4%
25
   2.0%
Related SAEs
4
   0.2%
1
   0.1%
12.Secondary Outcome
Title Number of Subjects Reporting SAEs Assessed by the Investigator as Possibly Related to Vaccination
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time Frame During the entire study period (from Day 0 up to Visit 5 [18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 14837 17338
Measure Type: Count of Participants
Unit of Measure: Participants
25
   0.2%
30
   0.2%
13.Secondary Outcome
Title Number of Subjects With New Onset of Autoimmune Diseases (NOADs), Retrieved From Care Register for Social Welfare and Health Care (HILMO)
Hide Description NOADs include colitis ulcerative, juvenile arthritis, type 1 diabetes mellitus, coeliac disease and Chron's disease, Basedow's disease, erythema nodosum VIIth nerve paralysis and psoriasis.
Time Frame During the entire study period (from day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 14837 17338
Measure Type: Count of Participants
Unit of Measure: Participants
149
   1.0%
180
   1.0%
14.Secondary Outcome
Title Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO
Hide Description

Pregnancies with onset during the study were classified by their outcome. Outcomes included live infant with no apparent congenital anomaly, elective termination with no apparent congenital anomaly, spontaneous abortion with no apparent congenital anomaly, ectopic pregnancy, stillbirth with no apparent congenital anomaly and molar pregnancy.

Note: The analysis was performed based on the corrected demographical data. Please refer to the rationale provided in the Baseline characteristics section.

Time Frame During the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the total number of pregnant subjects reported, part of the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description:
Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 777 567
Measure Type: Count of Participants
Unit of Measure: Participants
Live infant with no apparent anomaly
254
  32.7%
183
  32.3%
Elective termination with no apparent anomaly
454
  58.4%
332
  58.6%
Ectopic pregnancy
5
   0.6%
5
   0.9%
Spontaneous abortion with no apparent anomaly
62
   8.0%
45
   7.9%
Stillbirth with no apparent congenital anomaly
0
   0.0%
1
   0.2%
Molar pregnancy
2
   0.3%
1
   0.2%
15.Secondary Outcome
Title Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects
Hide Description The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5.
Time Frame At the time of Visit 1 (at Day 0), Visit 4 (at Month 7) and Visit 5 (at 18.5 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity-Immunogenicity subset, which comprised the same male study subjects from the Cervarix/Engerix-B A Group included in the Diary Card subset, plus approximately 1500 female study subjects from the same Cervarix/Engerix-B A Group, with assay results available at the considered time point.
Arm/Group Title Cervarix Pooled Group
Hide Arm/Group Description:
Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 1163
Measure Type: Count of Participants
Unit of Measure: Participants
anti-HPV-16 ≥ 8 EL.U/mL, males (Day 0) Number Analyzed 536 participants
40
   7.5%
anti-HPV-16 ≥ 8 EL.U/mL, males (Month 7) Number Analyzed 536 participants
536
 100.0%
anti-HPV-16 ≥ 19 EL.U/mL, males (18.5Y) Number Analyzed 217 participants
217
 100.0%
anti-HPV-16 ≥ 8 EL.U/mL, females (Day 0) Number Analyzed 1163 participants
86
   7.4%
anti-HPV-16 ≥ 8 EL.U/mL, females (Month 7) Number Analyzed 1163 participants
1163
 100.0%
anti-HPV-16 ≥ 19 EL.U/mL, females (18.5Y) Number Analyzed 688 participants
688
 100.0%
anti-HPV-18 ≥ 7 EL.U/mL, males (Day 0) Number Analyzed 535 participants
31
   5.8%
anti-HPV-18 ≥ 7 EL.U/mL, males (Month 7) Number Analyzed 535 participants
535
 100.0%
anti-HPV-18 ≥ 18 EL.U/mL, males (18.5Y) Number Analyzed 217 participants
217
 100.0%
anti-HPV-18 ≥ 7 EL.U/mL, females (Day 0) Number Analyzed 1160 participants
84
   7.2%
anti-HPV-18 ≥ 7 EL.U/mL, females (Month 7) Number Analyzed 1160 participants
1160
 100.0%
anti-HPV-18 ≥ 18 EL.U/mL, females (18.5Y) Number Analyzed 686 participants
685
  99.9%
16.Secondary Outcome
Title Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects
Hide Description The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5.
Time Frame At the time of Visit 1 (Day 0), Visit 4 (at Month 7) and at the time of Visit 5 (18.5 years of age)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity-Immunogenicity subset, which comprised the same male study subjects from the Cervarix/Engerix-B A Group included in the Diary Card subset, plus approximately 1500 female study subjects from the same Cervarix/Engerix-B A Group, with assay results available at the considered time point.
Arm/Group Title Cervarix Pooled Group
Hide Arm/Group Description:
Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Number of Participants Analyzed 1163
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
anti-HPV-16 ≥ 8 EL.U/mL, males (Day 0) Number Analyzed 536 participants
4.5
(4.3 to 4.6)
anti-HPV-16 ≥ 8 EL.U/mL, males (Month 7) Number Analyzed 536 participants
23959.1
(22301.0 to 25740.4)
anti-HPV-16 ≥ 19 EL.U/mL, males (18.5Y) Number Analyzed 217 participants
2759.5
(2432.1 to 3130.9)
anti-HPV-16 ≥ 8 EL.U/mL, females (Day 0) Number Analyzed 1163 participants
4.5
(4.4 to 4.6)
anti-HPV-16 ≥ 8 EL.U/mL, females (Month 7) Number Analyzed 1163 participants
21327.2
(20338.9 to 22363.5)
anti-HPV-16 ≥ 19 EL.U/mL, females (18.5Y) Number Analyzed 688 participants
2609.6
(2444.4 to 2785.9)
anti-HPV-18 ≥ 7 EL.U/mL, males (Day 0) Number Analyzed 535 participants
3.8
(3.7 to 4.0)
anti-HPV-18 ≥ 7 EL.U/mL, males (Month 7) Number Analyzed 535 participants
8583.9
(7974.7 to 9239.5)
anti-HPV-18 ≥ 18 EL.U/mL, males (18.5Y) Number Analyzed 217 participants
837.7
(727.3 to 964.9)
anti-HPV-18 ≥ 7 EL.U/mL, females (Day 0) Number Analyzed 1160 participants
3.9
(3.8 to 4.0)
anti-HPV-18 ≥ 7 EL.U/mL, females (Month 7) Number Analyzed 1160 participants
8227.3
(7847.7 to 8625.4)
anti-HPV-18 ≥ 18 EL.U/mL, females (18.5Y) Number Analyzed 686 participants
890.0
(826.2 to 958.7)
Time Frame Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5).
Adverse Event Reporting Description AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
 
Arm/Group Title Cervarix Pooled Group Engerix-B Pooled Group
Hide Arm/Group Description Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
All-Cause Mortality
Cervarix Pooled Group Engerix-B Pooled Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14837 (0.00%)      0/17338 (0.00%)    
Hide Serious Adverse Events
Cervarix Pooled Group Engerix-B Pooled Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   188/14837 (1.27%)      152/17338 (0.88%)    
Blood and lymphatic system disorders     
Splenomegaly  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Immune thrombocytopenic purpura  1  2/14837 (0.01%)  2 2/17338 (0.01%)  2
Congenital, familial and genetic disorders     
Vitello-intestinal duct remnant  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Endocrine disorders     
Thyroiditis  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Basedow's disease  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Gastrointestinal disorders     
Abdominal pain  1  2/14837 (0.01%)  2 0/17338 (0.00%)  0
Colitis ulcerative  1  12/14837 (0.08%)  12 14/17338 (0.08%)  14
Constipation  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Crohn's disease  1  7/14837 (0.05%)  7 15/17338 (0.09%)  15
Food poisoning  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Proctitis ulcerative  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
General disorders     
Chest pain  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Pyrexia  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Immune system disorders     
Anaphylactic reaction  1  2/14837 (0.01%)  2 0/17338 (0.00%)  0
Hypersensitivity  1  2/14837 (0.01%)  2 0/17338 (0.00%)  0
Infections and infestations     
Appendicitis  1  5/14837 (0.03%)  5 3/17338 (0.02%)  3
Appendicitis perforated  1  1/14837 (0.01%)  1 1/17338 (0.01%)  1
Bronchitis  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Encephalitis  1  0/14837 (0.00%)  0 2/17338 (0.01%)  2
Gastroenteritis bacterial  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Genital infection  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Infectious mononucleosis  1  4/14837 (0.03%)  4 1/17338 (0.01%)  1
Muscle abscess  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Pelvic infection  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Peritonsillar abscess  1  1/14837 (0.01%)  1 1/17338 (0.01%)  1
Pneumonia  1  2/14837 (0.01%)  2 0/17338 (0.00%)  0
Pneumonia bacterial  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Pyelonephritis  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Salmonellosis  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Sepsis  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Sinusitis  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Sinusitis bacterial  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Tonsillitis  1  4/14837 (0.03%)  4 0/17338 (0.00%)  0
Injury, poisoning and procedural complications     
Alcohol poisoning  1  3/14837 (0.02%)  3 1/17338 (0.01%)  1
Cervical vertebral fracture  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Concussion  1  4/14837 (0.03%)  4 0/17338 (0.00%)  0
Contusion  1  2/14837 (0.01%)  2 0/17338 (0.00%)  0
Foot fracture  1  0/14837 (0.00%)  0 2/17338 (0.01%)  2
Forearm fracture  1  1/14837 (0.01%)  1 1/17338 (0.01%)  1
Hand fracture  1  2/14837 (0.01%)  2 1/17338 (0.01%)  1
Joint dislocation  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Limb injury  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Lower limb fracture  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Muscle rupture  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Neck injury  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Radius fracture  1  2/14837 (0.01%)  2 0/17338 (0.00%)  0
Splenic rupture  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Tibia fracture  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Traumatic renal injury  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Upper limb fracture  1  2/14837 (0.01%)  2 0/17338 (0.00%)  0
Metabolism and nutrition disorders     
Type 1 diabetes mellitus  1  13/14837 (0.09%)  13 25/17338 (0.14%)  25
Musculoskeletal and connective tissue disorders     
Arthritis  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Arthritis reactive  1  0/14837 (0.00%)  0 2/17338 (0.01%)  2
Exostosis  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Juvenile idiopathic arthritis  1  3/14837 (0.02%)  3 4/17338 (0.02%)  4
Rheumatoid arthritis  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Sacroiliitis  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Sjogren's syndrome  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenoma benign  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Astrocytoma, low grade  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Benign hydatidiform mole  1  2/14837 (0.01%)  2 1/17338 (0.01%)  1
Nervous system disorders     
Cataplexy  1  2/14837 (0.01%)  2 1/17338 (0.01%)  1
Cerebral haemorrhage  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Epilepsy  1  1/14837 (0.01%)  1 2/17338 (0.01%)  2
Guillain-barre syndrome  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Headache  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Multiple sclerosis  1  2/14837 (0.01%)  2 1/17338 (0.01%)  1
Narcolepsy  1  2/14837 (0.01%)  2 1/17338 (0.01%)  1
Optic neuritis  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Syncope  1  2/14837 (0.01%)  2 1/17338 (0.01%)  1
Pregnancy, puerperium and perinatal conditions     
Abortion missed  1  10/14837 (0.07%)  10 15/17338 (0.09%)  15
Abortion spontaneous  1  32/14837 (0.22%)  32 18/17338 (0.10%)  20
Abortion spontaneous complete  1  4/14837 (0.03%)  4 2/17338 (0.01%)  3
Abortion spontaneous incomplete  1  10/14837 (0.07%)  11 3/17338 (0.02%)  3
Ectopic pregnancy  1  5/14837 (0.03%)  5 5/17338 (0.03%)  5
Peripartum haemorrhage  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Pre-eclampsia  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Premature baby  1  11/14837 (0.07%)  11 6/17338 (0.03%)  6
Small for dates baby  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Stillbirth  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Psychiatric disorders     
Anxiety  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Depression  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Disturbance in social behaviour  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Emotional disorder of childhood  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Hallucination  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Hypnagogic hallucination  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Panic disorder  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Psychotic disorder  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Sleep attacks  1  1/14837 (0.01%)  1 1/17338 (0.01%)  1
Suicide attempt  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Renal and urinary disorders     
Tubulointerstitial nephritis and uveitis syndrome  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Reproductive system and breast disorders     
Testicular torsion  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Hyperventilation  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Neonatal asphyxia  1  2/14837 (0.01%)  2 0/17338 (0.00%)  0
Pneumomediastinum  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Skin and subcutaneous tissue disorders     
Acne  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Dermatitis  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Henoch-schonlein purpura  1  1/14837 (0.01%)  1 1/17338 (0.01%)  1
Stevens-johnson syndrome  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
Urticaria  1  1/14837 (0.01%)  1 0/17338 (0.00%)  0
Vascular disorders     
Behcet's syndrome  1  0/14837 (0.00%)  0 1/17338 (0.01%)  1
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix Pooled Group Engerix-B Pooled Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   506/643 (78.69%)      411/1047 (39.26%)    
General disorders     
Pain  1 [1]  506/603 (83.91%)  251/1028 (24.42%) 
Redness  1 [1]  169/603 (28.03%)  131/1028 (12.74%) 
Arthralgia  1 [1]  107/604 (17.72%)  97/1028 (9.44%) 
Fatigue  1 [1]  291/604 (48.18%)  411/1028 (39.98%) 
Fever (Axillary)  1 [1]  48/604 (7.95%)  85/1028 (8.27%) 
Gastrointestinal  1 [1]  106/604 (17.55%)  163/1028 (15.86%) 
Headache  1 [1]  261/604 (43.21%)  371/1028 (36.09%) 
Swelling  1 [1]  131/603 (21.72%)  46/1028 (4.47%) 
Myalgia  1 [1]  321/604 (53.15%)  250/1028 (24.32%) 
Infections and infestations     
Nasopharyngitis  1 [2]  33/643 (5.13%)  17/1047 (1.62%) 
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
[1]
Solicited symptom during the 7-day post-vaccination period (across doses).
[2]
Unsolicited symptom during the 30-day post-vaccination period (across doses).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00534638    
Other Study ID Numbers: 106636
2007-001731-55 ( EudraCT Number )
First Submitted: September 24, 2007
First Posted: September 26, 2007
Results First Submitted: December 17, 2015
Results First Posted: January 26, 2016
Last Update Posted: November 15, 2019