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Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.

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ClinicalTrials.gov Identifier: NCT00309166
Recruitment Status : Completed
First Posted : March 31, 2006
Results First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Infections, Papillomavirus
Interventions Biological: Cervarix vaccine
Biological: Engerix-B vaccine
Enrollment 270
Recruitment Details  
Pre-assignment Details During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Arm/Group Title Cervarix Group Engerix-B Group
Hide Arm/Group Description Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12. Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Period Title: Overall Study
Started 181 89
Completed 176 86
Not Completed 5 3
Reason Not Completed
Adverse event, non-fatal             1             0
Withdrawal by Subject             4             3
Arm/Group Title Cervarix Group Engerix-B Group Total
Hide Arm/Group Description Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12. Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12. Total of all reporting groups
Overall Number of Baseline Participants 181 89 270
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 181 participants 89 participants 270 participants
14.4  (2.14) 14.4  (2.02) 14.4  (2.10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants 89 participants 270 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
181
 100.0%
89
 100.0%
270
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Geographic ancestry Number Analyzed 181 participants 89 participants 270 participants
African heritage/African American
1
   0.6%
0
   0.0%
1
   0.4%
Asian-Central/South Asian heritage
1
   0.6%
0
   0.0%
1
   0.4%
White-Arabic/North African heritage
1
   0.6%
0
   0.0%
1
   0.4%
White-Caucasian/European heritage
177
  97.8%
88
  98.9%
265
  98.1%
Not specified
1
   0.6%
1
   1.1%
2
   0.7%
1.Primary Outcome
Title Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
Hide Description Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies [anti-HPV-16 titers greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 titres ≥7 EL.U/mL] in the serum of subjects seronegative before vaccination.
Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.
Arm/Group Title Cervarix Group Engerix-B Group
Hide Arm/Group Description:
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Overall Number of Participants Analyzed 163 86
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 163 participants 83 participants
163
 100.0%
1
   1.2%
HPV-18 Number Analyzed 150 participants 86 participants
150
 100.0%
2
   2.3%
2.Primary Outcome
Title Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)
Hide Description Titers were presented as geometric mean titers (GMT).
Time Frame At Month 7
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.
Arm/Group Title Cervarix Group Engerix-B Group
Hide Arm/Group Description:
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Overall Number of Participants Analyzed 171 86
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
HPV-16 Number Analyzed 171 participants 86 participants
22564.8
(19800.3 to 25715.4)
4.2
(4.0 to 4.5)
HPV-18 Number Analyzed 170 participants 86 participants
8460.3
(7306.1 to 9796.8)
3.6
(3.4 to 3.8)
3.Secondary Outcome
Title Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
Hide Description Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titres ≥ 8 EL.U/mL and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination.
Time Frame At Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.
Arm/Group Title Cervarix Group Engerix-B Group
Hide Arm/Group Description:
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Overall Number of Participants Analyzed 165 86
Measure Type: Count of Participants
Unit of Measure: Participants
HPV-16 Number Analyzed 165 participants 83 participants
165
 100.0%
0
   0.0%
HPV-18 Number Analyzed 152 participants 86 participants
152
 100.0%
4
   4.7%
4.Secondary Outcome
Title Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)
Hide Description Titers were presented as GMTs.
Time Frame At Month 2
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.
Arm/Group Title Cervarix Group Engerix-B Group
Hide Arm/Group Description:
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Overall Number of Participants Analyzed 173 86
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
HPV-16 Number Analyzed 173 participants 86 participants
5254.5
(4704.9 to 5868.2)
4.1
(4 to 4.3)
HPV-18 Number Analyzed 172 participants 86 participants
3696.9
(3275.9 to 4172.1)
3.7
(3.5 to 3.8)
5.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description Solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade; Grade 3 pain = pain that prevented normal activity; Grade 3 redness/swelling = redness/swelling spreading beyond (>) 50 mm.
Time Frame Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
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 and who had filled in the symptom sheet.
Arm/Group Title Cervarix Group Engerix-B Group
Hide Arm/Group Description:
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Overall Number of Participants Analyzed 180 88
Measure Type: Count of Participants
Unit of Measure: Participants
Pain, Dose 1 Number Analyzed 180 participants 88 participants
149
  82.8%
25
  28.4%
Grade 3 Pain, Dose 1 Number Analyzed 180 participants 88 participants
1
   0.6%
0
   0.0%
Redness, Dose 1 Number Analyzed 180 participants 88 participants
24
  13.3%
12
  13.6%
Grade 3 Redness, Dose 1 Number Analyzed 180 participants 88 participants
0
   0.0%
0
   0.0%
Swelling, Dose 1 Number Analyzed 180 participants 88 participants
7
   3.9%
3
   3.4%
Grade 3 Swelling, Dose 1 Number Analyzed 180 participants 88 participants
0
   0.0%
0
   0.0%
Pain, Dose 2 Number Analyzed 172 participants 86 participants
114
  66.3%
16
  18.6%
Grade 3 Pain, Dose 2 Number Analyzed 172 participants 86 participants
2
   1.2%
0
   0.0%
Redness, Dose 2 Number Analyzed 172 participants 86 participants
30
  17.4%
8
   9.3%
Grade 3 Redness, Dose 2 Number Analyzed 172 participants 86 participants
0
   0.0%
0
   0.0%
Swelling, Dose 2 Number Analyzed 172 participants 86 participants
20
  11.6%
2
   2.3%
Grade 3 Swelling, Dose 2 Number Analyzed 172 participants 86 participants
0
   0.0%
1
   1.2%
Pain, Dose 3 Number Analyzed 171 participants 85 participants
115
  67.3%
16
  18.8%
Grade 3 Pain, Dose 3 Number Analyzed 171 participants 85 participants
7
   4.1%
0
   0.0%
Redness, Dose 3 Number Analyzed 171 participants 85 participants
33
  19.3%
9
  10.6%
Grade 3 Redness, Dose 3 Number Analyzed 171 participants 85 participants
0
   0.0%
0
   0.0%
Swelling, Dose 3 Number Analyzed 171 participants 85 participants
29
  17.0%
3
   3.5%
Grade 3 Swelling, Dose 3 Number Analyzed 171 participants 85 participants
2
   1.2%
0
   0.0%
Pain, Across doses Number Analyzed 180 participants 88 participants
159
  88.3%
39
  44.3%
Grade 3 Pain, Across doses Number Analyzed 180 participants 88 participants
8
   4.4%
0
   0.0%
Redness, Across doses Number Analyzed 180 participants 88 participants
51
  28.3%
15
  17.0%
Grade 3 Redness, Across doses Number Analyzed 180 participants 88 participants
0
   0.0%
0
   0.0%
Swelling, Across doses Number Analyzed 180 participants 88 participants
36
  20.0%
7
   8.0%
Grade 3 Swelling, Across doses Number Analyzed 180 participants 88 participants
2
   1.1%
1
   1.1%
6.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description Solicited general symptoms assessed were arthralgia, fatigue, fever (defined as axillary temperature ≥37.5 °C), gastrointestinal, headache, myalgia, rash and urticaria. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination; Grade 3 = symptom that prevented normal activity; Grade 3 fever = temperature > 39.0 °C; Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Time Frame Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
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 and who had filled in the symptom sheets.
Arm/Group Title Cervarix Group Engerix-B Group
Hide Arm/Group Description:
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Overall Number of Participants Analyzed 180 88
Measure Type: Count of Participants
Unit of Measure: Participants
Arthralgia, Dose 1 Number Analyzed 180 participants 88 participants
17
   9.4%
7
   8.0%
Grade 3 Athralgia, Dose 1 Number Analyzed 180 participants 88 participants
0
   0.0%
0
   0.0%
Related Athralgia, Dose 1 Number Analyzed 180 participants 88 participants
10
   5.6%
3
   3.4%
Fatigue, Dose 1 Number Analyzed 180 participants 88 participants
51
  28.3%
32
  36.4%
Grade 3 Fatigue, Dose 1 Number Analyzed 180 participants 88 participants
1
   0.6%
0
   0.0%
Related Fatigue, Dose 1 Number Analyzed 180 participants 88 participants
26
  14.4%
18
  20.5%
Fever (axillary), Dose 1 Number Analyzed 180 participants 88 participants
24
  13.3%
11
  12.5%
Grade 3 Fever, Dose 1 Number Analyzed 180 participants 88 participants
0
   0.0%
0
   0.0%
Related Fever, Dose 1 Number Analyzed 180 participants 88 participants
1
   0.6%
1
   1.1%
Gastrointestinal, Dose 1 Number Analyzed 180 participants 88 participants
33
  18.3%
10
  11.4%
Grade 3 Gastrointestinal, Dose 1 Number Analyzed 180 participants 88 participants
2
   1.1%
0
   0.0%
Related Gastrointestinal, Dose 1 Number Analyzed 180 participants 88 participants
15
   8.3%
5
   5.7%
Headache, Dose 1 Number Analyzed 180 participants 88 participants
51
  28.3%
21
  23.9%
Grade 3 Headache, Dose 1 Number Analyzed 180 participants 88 participants
0
   0.0%
0
   0.0%
Related Headache, Dose 1 Number Analyzed 180 participants 88 participants
24
  13.3%
7
   8.0%
Myalgia, Dose 1 Number Analyzed 180 participants 88 participants
67
  37.2%
16
  18.2%
Grade 3 Mylagia, Dose 1 Number Analyzed 180 participants 88 participants
1
   0.6%
0
   0.0%
Related Mylagia, Dose 1 Number Analyzed 180 participants 88 participants
45
  25.0%
7
   8.0%
Rash, Dose 1 Number Analyzed 180 participants 88 participants
8
   4.4%
1
   1.1%
Grade 3 Rash, Dose 1 Number Analyzed 180 participants 88 participants
0
   0.0%
0
   0.0%
Related Rash, Dose 1 Number Analyzed 180 participants 88 participants
2
   1.1%
1
   1.1%
Urticaria, Dose 1 Number Analyzed 180 participants 88 participants
3
   1.7%
0
   0.0%
Grade 3 Urticaria, Dose 1 Number Analyzed 180 participants 88 participants
0
   0.0%
0
   0.0%
Related Urticaria, Dose 1 Number Analyzed 180 participants 88 participants
1
   0.6%
0
   0.0%
Arthralgia, Dose 2 Number Analyzed 173 participants 86 participants
6
   3.5%
3
   3.5%
Grade 3 Arthralgia, Dose 2 Number Analyzed 173 participants 86 participants
0
   0.0%
1
   1.2%
Related Arthralgia, Dose 2 Number Analyzed 173 participants 86 participants
3
   1.7%
0
   0.0%
Fatigue, Dose 2 Number Analyzed 173 participants 86 participants
35
  20.2%
14
  16.3%
Grade 3 Fatigue, Dose 2 Number Analyzed 173 participants 86 participants
1
   0.6%
0
   0.0%
Related Fatigue, Dose 2 Number Analyzed 173 participants 86 participants
21
  12.1%
9
  10.5%
Fever (axillary), Dose 2 Number Analyzed 173 participants 86 participants
14
   8.1%
6
   7.0%
Grade 3 Fever, Dose 2 Number Analyzed 173 participants 86 participants
0
   0.0%
0
   0.0%
Related Fever, Dose 2 Number Analyzed 173 participants 86 participants
1
   0.6%
0
   0.0%
Gastrointestinal, Dose 2 Number Analyzed 173 participants 86 participants
18
  10.4%
4
   4.7%
Grade 3 Gastrointestinal, Dose 2 Number Analyzed 173 participants 86 participants
1
   0.6%
1
   1.2%
Related Gastrointestinal, Dose 2 Number Analyzed 173 participants 86 participants
7
   4.0%
0
   0.0%
Headache, Dose 2 Number Analyzed 173 participants 86 participants
30
  17.3%
13
  15.1%
Grade 3 Headache, Dose 2 Number Analyzed 173 participants 86 participants
2
   1.2%
1
   1.2%
Related Headache, Dose 2 Number Analyzed 173 participants 86 participants
14
   8.1%
7
   8.1%
Myalgia, Dose 2 Number Analyzed 173 participants 86 participants
35
  20.2%
8
   9.3%
Grade 3 Maylagia, Dose 2 Number Analyzed 173 participants 86 participants
1
   0.6%
0
   0.0%
Related Maylagia, Dose 2 Number Analyzed 173 participants 86 participants
27
  15.6%
7
   8.1%
Rash, Dose 2 Number Analyzed 173 participants 86 participants
8
   4.6%
2
   2.3%
Grade 3 Rash, Dose 2 Number Analyzed 173 participants 86 participants
0
   0.0%
0
   0.0%
Related Rash, Dose 2 Number Analyzed 173 participants 86 participants
3
   1.7%
0
   0.0%
Urticaria, Dose 2 Number Analyzed 173 participants 86 participants
1
   0.6%
2
   2.3%
Grade 3 Urticaria, Dose 2 Number Analyzed 173 participants 86 participants
0
   0.0%
0
   0.0%
Related Urticaria, Dose 2 Number Analyzed 173 participants 86 participants
0
   0.0%
0
   0.0%
Arthralgia, Dose 3 Number Analyzed 170 participants 85 participants
12
   7.1%
3
   3.5%
Grade 3 Arthralgia, Dose 3 Number Analyzed 170 participants 85 participants
0
   0.0%
0
   0.0%
Related Arthtralgia, Dose 3 Number Analyzed 170 participants 85 participants
12
   7.1%
3
   3.5%
Fatigue, Dose 3 Number Analyzed 170 participants 85 participants
44
  25.9%
15
  17.6%
Grade 3 Fatigue, Dose 3 Number Analyzed 170 participants 85 participants
2
   1.2%
0
   0.0%
Related Fatigue, Dose 3 Number Analyzed 170 participants 85 participants
30
  17.6%
11
  12.9%
Fever (axillary), Dose 3 Number Analyzed 170 participants 85 participants
14
   8.2%
4
   4.7%
Grade 3 Fever, Dose 3 Number Analyzed 170 participants 85 participants
0
   0.0%
0
   0.0%
Related Fever, Dose 3 Number Analyzed 170 participants 85 participants
1
   0.6%
0
   0.0%
Gastrointestinal, Dose 3 Number Analyzed 170 participants 85 participants
10
   5.9%
5
   5.9%
Grade 3 Gastrointestinal, Dose 3 Number Analyzed 170 participants 85 participants
1
   0.6%
0
   0.0%
Related Gastrointestinal, Dose 3 Number Analyzed 170 participants 85 participants
8
   4.7%
4
   4.7%
Headache, Dose 3 Number Analyzed 170 participants 85 participants
30
  17.6%
11
  12.9%
Grade 3 Headache, Dose 3 Number Analyzed 170 participants 85 participants
3
   1.8%
0
   0.0%
Related Headache, Dose 3 Number Analyzed 170 participants 85 participants
17
  10.0%
8
   9.4%
Myalgia, Dose 3 Number Analyzed 170 participants 85 participants
39
  22.9%
8
   9.4%
Grade 3 Mylagia, Dose 3 Number Analyzed 170 participants 85 participants
1
   0.6%
0
   0.0%
Related Mylagia, Dose 3 Number Analyzed 170 participants 85 participants
35
  20.6%
6
   7.1%
Rash, Dose 3 Number Analyzed 170 participants 85 participants
3
   1.8%
2
   2.4%
Grade 3 Rash, Dose 3 Number Analyzed 170 participants 85 participants
0
   0.0%
0
   0.0%
Related Rash, Dose 3 Number Analyzed 170 participants 85 participants
1
   0.6%
0
   0.0%
Urticaria, Dose 3 Number Analyzed 170 participants 85 participants
0
   0.0%
0
   0.0%
Grade 3 Urticaria, Dose 3 Number Analyzed 170 participants 85 participants
0
   0.0%
0
   0.0%
Related Urticaria, Dose 3 Number Analyzed 170 participants 85 participants
0
   0.0%
0
   0.0%
Arthralgia, Across doses Number Analyzed 180 participants 88 participants
29
  16.1%
10
  11.4%
Grade 3 Arthralgia, Across doses Number Analyzed 180 participants 88 participants
0
   0.0%
1
   1.1%
Related Arthralgia, Across doses Number Analyzed 180 participants 88 participants
22
  12.2%
5
   5.7%
Fatigue, Across doses Number Analyzed 180 participants 88 participants
82
  45.6%
42
  47.7%
Grade 3 Fatigue, Across doses Number Analyzed 180 participants 88 participants
4
   2.2%
0
   0.0%
Related Fatigue, Across doses Number Analyzed 180 participants 88 participants
52
  28.9%
33
  37.5%
Fever (axillary), Across doses Number Analyzed 180 participants 88 participants
35
  19.4%
17
  19.3%
Grade 3 Fever, Across doses Number Analyzed 180 participants 88 participants
0
   0.0%
0
   0.0%
Related Fever, Across doses Number Analyzed 180 participants 88 participants
3
   1.7%
1
   1.1%
Gastrointestinal, Across doses Number Analyzed 180 participants 88 participants
40
  22.2%
14
  15.9%
Grade 3 Gastrointestinal, Across doses Number Analyzed 180 participants 88 participants
4
   2.2%
1
   1.1%
Related Gastrointestinal, Across doses Number Analyzed 180 participants 88 participants
19
  10.6%
7
   8.0%
Headache, Across doses Number Analyzed 180 participants 88 participants
77
  42.8%
33
  37.5%
Grade 3 Headache, Across doses Number Analyzed 180 participants 88 participants
5
   2.8%
1
   1.1%
Related Headache, Across doses Number Analyzed 180 participants 88 participants
43
  23.9%
16
  18.2%
Myalgia, Across doses Number Analyzed 180 participants 88 participants
88
  48.9%
23
  26.1%
Grade 3 Mylagia, Across doses Number Analyzed 180 participants 88 participants
3
   1.7%
0
   0.0%
Related Mylagia, Across doses Number Analyzed 180 participants 88 participants
70
  38.9%
14
  15.9%
Rash, Across doses Number Analyzed 180 participants 88 participants
16
   8.9%
5
   5.7%
Grade 3 Rash, Across doses Number Analyzed 180 participants 88 participants
0
   0.0%
0
   0.0%
Related Rash, Across doses Number Analyzed 180 participants 88 participants
5
   2.8%
1
   1.1%
Urticaria, Across doses Number Analyzed 180 participants 88 participants
4
   2.2%
2
   2.3%
Grade 3 Urticaria, Across doses Number Analyzed 180 participants 88 participants
0
   0.0%
0
   0.0%
Related Urticaria, Across doses Number Analyzed 180 participants 88 participants
1
   0.6%
0
   0.0%
7.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
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 30 days (Day 0-29) after any vaccination, up to 7 months
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 Group Engerix-B Group
Hide Arm/Group Description:
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Overall Number of Participants Analyzed 181 89
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
68
  37.6%
31
  34.8%
Grade 3 AEs
5
   2.8%
2
   2.2%
Related AEs
5
   2.8%
1
   1.1%
8.Secondary Outcome
Title Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions
Hide Description NOCDs include asthma, Chron`s disease, dermatitis atopic. MSCs include 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 and injury.
Time Frame Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
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 up to Month 7 and on the Extended Safety Follow-Up (ESFU) Total Vaccinated cohort, which included all vaccinated subjects that could be contacted by telephone for the Safety follow-up at Month 12.
Arm/Group Title Cervarix Group Engerix-B Group
Hide Arm/Group Description:
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Overall Number of Participants Analyzed 181 89
Measure Type: Count of Participants
Unit of Measure: Participants
NOCDs, Month 7 Number Analyzed 181 participants 89 participants
2
   1.1%
1
   1.1%
MSCs, Month 7 Number Analyzed 181 participants 89 participants
22
  12.2%
10
  11.2%
NOCDs, Month 7 to Month 12 Number Analyzed 175 participants 86 participants
0
   0.0%
0
   0.0%
MSCs, Month 7 to Month 12 Number Analyzed 175 participants 86 participants
1
   0.6%
2
   2.3%
9.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
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 up to Month 7 and on the Extended Safety Follow-Up (ESFU) Total Vaccinated cohort, which included all vaccinated subjects that could be contacted by telephone for the Safety follow-up at Month 12.
Arm/Group Title Cervarix Group Engerix-B Group
Hide Arm/Group Description:
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Overall Number of Participants Analyzed 181 89
Measure Type: Count of Participants
Unit of Measure: Participants
SAEs, Month 7 Number Analyzed 181 participants 89 participants
2
   1.1%
0
   0.0%
SAEs, Month 12 Number Analyzed 175 participants 86 participants
1
   0.6%
1
   1.2%
10.Secondary Outcome
Title Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Hide Description The occurence of clinically relevant abnormalities was assessed in the following biochemical and haematological parameters: alanine aminotransferase [ALT], basophils [BAS], creatinine [CREA], eosinophils [EOS] and hematocrit [Hem]. Levels of haematological/biochemical parameters assessed in terms of normal, below and above laboratory values were - normal, below, above and missing.
Time Frame At Month 2 and Month 7, post-vaccination
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 Group Engerix-B Group
Hide Arm/Group Description:
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Overall Number of Participants Analyzed 172 86
Measure Type: Count of Participants
Unit of Measure: Participants
ALT Normal, Month 2, Normal Number Analyzed 172 participants 86 participants
166
  96.5%
79
  91.9%
ALT Normal, Month 2, Below Number Analyzed 172 participants 86 participants
3
   1.7%
0
   0.0%
ALT Normal, Month 2, Above Number Analyzed 172 participants 86 participants
3
   1.7%
2
   2.3%
ALT Normal, Month 2, Missing Number Analyzed 172 participants 86 participants
0
   0.0%
5
   5.8%
ALT Normal, Month 7, Normal Number Analyzed 171 participants 84 participants
165
  96.5%
81
  96.4%
ALT Normal, Month 7, Below Number Analyzed 171 participants 84 participants
1
   0.6%
0
   0.0%
ALT Normal, Month 7, Above Number Analyzed 171 participants 84 participants
5
   2.9%
3
   3.6%
ALT Below, Month 2, Normal Number Analyzed 1 participants 0 participants
0
   0.0%
0
ALT Below, Month 2, Below Number Analyzed 1 participants 0 participants
1
 100.0%
0
ALT Below, Month 2, Above Number Analyzed 1 participants 0 participants
0
   0.0%
0
ALT Below, Month 7, Normal Number Analyzed 1 participants 0 participants
0
   0.0%
0
ALT Below, Month 7, Below Number Analyzed 1 participants 0 participants
1
 100.0%
0
ALT Below, Month 7, Above Number Analyzed 1 participants 0 participants
0
   0.0%
0
ALT Above, Month 2, Normal Number Analyzed 4 participants 1 participants
2
  50.0%
0
   0.0%
ALT Above, Month 2, Below Number Analyzed 4 participants 1 participants
0
   0.0%
0
   0.0%
ALT Above, Month 2, Above Number Analyzed 4 participants 1 participants
2
  50.0%
0
   0.0%
ALT Above, Month 2, Missing Number Analyzed 4 participants 1 participants
0
   0.0%
1
 100.0%
ALT Above, Month 7, Normal Number Analyzed 3 participants 1 participants
2
  66.7%
0
   0.0%
ALT Above, Month 7, Below Number Analyzed 3 participants 1 participants
0
   0.0%
0
   0.0%
ALT Above, Month 7, Above Number Analyzed 3 participants 1 participants
1
  33.3%
1
 100.0%
BAS Normal, Month 2, Normal Number Analyzed 146 participants 76 participants
140
  95.9%
65
  85.5%
BAS Normal, Month 2, Below Number Analyzed 146 participants 76 participants
0
   0.0%
0
   0.0%
BAS Normal, Month 2, Above Number Analyzed 146 participants 76 participants
3
   2.1%
3
   3.9%
BAS Normal, Month 2, Missing Number Analyzed 146 participants 76 participants
3
   2.1%
8
  10.5%
BAS Normal, Month 7, Normal Number Analyzed 145 participants 74 participants
134
  92.4%
66
  89.2%
BAS Normal, Month 7, Below Number Analyzed 145 participants 74 participants
0
   0.0%
0
   0.0%
BAS Normal, Month 7, Above Number Analyzed 145 participants 74 participants
11
   7.6%
8
  10.8%
BAS Above, Month 2, Normal Number Analyzed 18 participants 6 participants
12
  66.7%
5
  83.3%
BAS Above, Month 2, Below Number Analyzed 18 participants 6 participants
0
   0.0%
0
   0.0%
BAS Above, Month 2, Above Number Analyzed 18 participants 6 participants
6
  33.3%
1
  16.7%
BAS Above, Month 7, Normal Number Analyzed 18 participants 6 participants
14
  77.8%
4
  66.7%
BAS Above, Month 7, Below Number Analyzed 18 participants 6 participants
0
   0.0%
0
   0.0%
BAS Above, Month 7, Above Number Analyzed 18 participants 6 participants
4
  22.2%
2
  33.3%
EOS Normal, Month 2, Normal Number Analyzed 125 participants 68 participants
102
  81.6%
48
  70.6%
EOS Normal, Month 2, Below Number Analyzed 125 participants 68 participants
4
   3.2%
2
   2.9%
EOS Normal, Month 2, Above Number Analyzed 125 participants 68 participants
17
  13.6%
10
  14.7%
EOS Normal, Month 2, Missing Number Analyzed 125 participants 68 participants
2
   1.6%
8
  11.8%
EOS Normal, Month 7, Normal Number Analyzed 125 participants 67 participants
108
  86.4%
54
  80.6%
EOS Normal, Month 7, Below Number Analyzed 125 participants 67 participants
8
   6.4%
4
   6.0%
EOS Normal, Month 7, Above Number Analyzed 125 participants 67 participants
9
   7.2%
9
  13.4%
EOS Below, Month 2, Normal Number Analyzed 4 participants 3 participants
4
 100.0%
2
  66.7%
EOS Below, Month 2, Below Number Analyzed 4 participants 3 participants
0
   0.0%
1
  33.3%
EOS Below, Month 2, Above Number Analyzed 4 participants 3 participants
0
   0.0%
0
   0.0%
EOS Below, Month 7, Normal Number Analyzed 4 participants 2 participants
2
  50.0%
1
  50.0%
EOS Below, Month 7, Below Number Analyzed 4 participants 2 participants
2
  50.0%
1
  50.0%
EOS Below, Month 7, Above Number Analyzed 4 participants 2 participants
0
   0.0%
0
   0.0%
EOS Above, Month 2, Normal Number Analyzed 36 participants 11 participants
6
  16.7%
5
  45.5%
EOS Above, Month 2, Below Number Analyzed 36 participants 11 participants
0
   0.0%
0
   0.0%
EOS Above, Month 2, Above Number Analyzed 36 participants 11 participants
30
  83.3%
6
  54.5%
EOS Above, Month 7, Normal Number Analyzed 35 participants 11 participants
8
  22.9%
5
  45.5%
EOS Above, Month 7, Below Number Analyzed 35 participants 11 participants
0
   0.0%
0
   0.0%
EOS Above, Month 7, Above Number Analyzed 35 participants 11 participants
27
  77.1%
6
  54.5%
CREA Normal, Month 2, Normal Number Analyzed 163 participants 82 participants
158
  96.9%
76
  92.7%
CREA Normal, Month 2, Below Number Analyzed 163 participants 82 participants
0
   0.0%
0
   0.0%
CREA Normal, Month 2, Above Number Analyzed 163 participants 82 participants
5
   3.1%
0
   0.0%
CREA Normal, Month 2, Missing Number Analyzed 163 participants 82 participants
0
   0.0%
6
   7.3%
CREA Normal, Month 7, Normal Number Analyzed 161 participants 80 participants
159
  98.8%
79
  98.8%
CREA Normal, Month 7, Below Number Analyzed 161 participants 80 participants
0
   0.0%
0
   0.0%
CREA Normal, Month 7, Above Number Analyzed 161 participants 80 participants
2
   1.2%
1
   1.3%
CREA Above, Month 2, Normal Number Analyzed 13 participants 5 participants
10
  76.9%
3
  60.0%
CREA Above, Month 2, Below Number Analyzed 13 participants 5 participants
0
   0.0%
0
   0.0%
CREA Above, Month 2, Above Number Analyzed 13 participants 5 participants
3
  23.1%
2
  40.0%
CREA Above, Month 7, Normal Number Analyzed 13 participants 5 participants
10
  76.9%
5
 100.0%
CREA Above, Month 7, Below Number Analyzed 13 participants 5 participants
0
   0.0%
0
   0.0%
CREA Above, Month 7, Above Number Analyzed 13 participants 5 participants
3
  23.1%
0
   0.0%
HEM Normal, Month 2, Normal Number Analyzed 159 participants 81 participants
155
  97.5%
76
  93.8%
HEM Normal, Month 2, Below Number Analyzed 159 participants 81 participants
2
   1.3%
0
   0.0%
HEM Normal, Month 2, Above Number Analyzed 159 participants 81 participants
2
   1.3%
0
   0.0%
HEM Normal, Month 2, Missing Number Analyzed 159 participants 81 participants
0
   0.0%
5
   6.2%
HEM Normal, Month 7, Normal Number Analyzed 158 participants 79 participants
147
  93.0%
73
  92.4%
HEM Normal, Month 7, Below Number Analyzed 158 participants 79 participants
9
   5.7%
6
   7.6%
HEM Normal, Month 7, Above Number Analyzed 158 participants 79 participants
2
   1.3%
0
   0.0%
HEM Below, Month 2, Normal Number Analyzed 4 participants 1 participants
3
  75.0%
1
 100.0%
HEM Below, Month 2, Below Number Analyzed 4 participants 1 participants
1
  25.0%
0
   0.0%
HEM Below, Month 2, Above Number Analyzed 4 participants 1 participants
0
   0.0%
0
   0.0%
HEM Below, Month 7, Normal Number Analyzed 4 participants 1 participants
2
  50.0%
1
 100.0%
HEM Below, Month 7, Below Number Analyzed 4 participants 1 participants
2
  50.0%
0
   0.0%
HEM Below, Month 7, Above Number Analyzed 4 participants 1 participants
0
   0.0%
0
   0.0%
HEM Above, Month 2, Normal Number Analyzed 6 participants 2 participants
3
  50.0%
0
   0.0%
HEM Above, Month 2, Below Number Analyzed 6 participants 2 participants
0
   0.0%
0
   0.0%
HEM Above, Month 2, Above Number Analyzed 6 participants 2 participants
3
  50.0%
1
  50.0%
HEM Above, Month 2, Missing Number Analyzed 6 participants 2 participants
0
   0.0%
1
  50.0%
HEM Above, Month 7, Normal Number Analyzed 6 participants 2 participants
6
 100.0%
1
  50.0%
HEM Above, Month 7, Below Number Analyzed 6 participants 2 participants
0
   0.0%
0
   0.0%
HEM Above, Month 7, Above Number Analyzed 6 participants 2 participants
0
   0.0%
1
  50.0%
11.Secondary Outcome
Title Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Hide Description The occurence of clinically relevant abnormalities was assessed in the following biochemical and haematological parameters: lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal, below and above laboratory values were - normal, below, above and missing.
Time Frame At Month 2 and at Month 7, post-vaccination
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 Group Engerix-B Group
Hide Arm/Group Description:
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
Overall Number of Participants Analyzed 164 82
Measure Type: Count of Participants
Unit of Measure: Participants
LYM Normal, Month 2, Normal Number Analyzed 142 participants 71 participants
117
  82.4%
56
  78.9%
LYM Normal, Month 2, Below Number Analyzed 142 participants 71 participants
5
   3.5%
1
   1.4%
LYM Normal, Month 2, Above Number Analyzed 142 participants 71 participants
18
  12.7%
6
   8.5%
LYM Normal, Month 2, Missing Number Analyzed 142 participants 71 participants
2
   1.4%
8
  11.3%
LYM Normal, Month 7, Normal Number Analyzed 142 participants 69 participants
126
  88.7%
63
  91.3%
LYM Normal, Month 7, Below Number Analyzed 142 participants 69 participants
4
   2.8%
1
   1.4%
LYM Normal, Month 7, Above Number Analyzed 142 participants 69 participants
12
   8.5%
5
   7.2%
LYM Below, Month 2, Normal Number Analyzed 3 participants 1 participants
1
  33.3%
1
 100.0%
LYM Below, Month 2, Below Number Analyzed 3 participants 1 participants
2
  66.7%
0
   0.0%
LYM Below, Month 2, Above Number Analyzed 3 participants 1 participants
0
   0.0%
0
   0.0%
LYM Below, Month 7, Normal Number Analyzed 3 participants 1 participants
2
  66.7%
1
 100.0%
LYM Below, Month 7, Below Number Analyzed 3 participants 1 participants
1
  33.3%
0
   0.0%
LYM Below, Month 7, Above Number Analyzed 3 participants 1 participants
0
   0.0%
0
   0.0%
LYM Above, Month 2, Normal Number Analyzed 20 participants 10 participants
11
  55.0%
5
  50.0%
LYM Above, Month 2, Below Number Analyzed 20 participants 10 participants
1
   5.0%
0
   0.0%
LYM Above, Month 2, Above Number Analyzed 20 participants 10 participants
8
  40.0%
5
  50.0%
LYM Above, Month 7, Normal Number Analyzed 19 participants 10 participants
11
  57.9%
8
  80.0%
LYM Above, Month 7, Below Number Analyzed 19 participants 10 participants
0
   0.0%
0
   0.0%
LYM Above, Month 7, Above Number Analyzed 19 participants 10 participants
8
  42.1%
2
  20.0%
MON Normal, Month 2, Normal Number Analyzed 108 participants 50 participants
92
  85.2%
38
  76.0%
MON Normal, Month 2, Below Number Analyzed 108 participants 50 participants
0
   0.0%
0
   0.0%
MON Normal, Month 2, Above Number Analyzed 108 participants 50 participants
15
  13.9%
5
  10.0%
MON Normal, Month 2, Missing Number Analyzed 108 participants 50 participants
1
   0.9%
7
  14.0%
MON Normal, Month 7, Normal Number Analyzed 108 participants 48 participants
93
  86.1%
43
  89.6%
MON Normal, Month 7, Below Number Analyzed 108 participants 48 participants
0
   0.0%
1
   2.1%
MON Normal, Month 7, Above Number Analyzed 108 participants 48 participants
15
  13.9%
4
   8.3%
MON Below, Month 2, Normal Number Analyzed 1 participants 3 participants
1
 100.0%
3
 100.0%
MON Below, Month 2, Below Number Analyzed 1 participants 3 participants
0
   0.0%
0
   0.0%
MON Below, Month 2, Above Number Analyzed 1 participants 3 participants
0
   0.0%
0
   0.0%
MON Below, Month 7, Normal Number Analyzed 1 participants 3 participants
0
   0.0%
3
 100.0%
MON Below, Month 7, Below Number Analyzed 1 participants 3 participants
1
 100.0%
0
   0.0%
MON Below, Month 7, Above Number Analyzed 1 participants 3 participants
0
   0.0%
0
   0.0%
MON Above, Month 2, Normal Number Analyzed 56 participants 29 participants
7
  12.5%
8
  27.6%
MON Above, Month 2, Below Number Analyzed 56 participants 29 participants
0
   0.0%
0
   0.0%
MON Above, Month 2, Above Number Analyzed 56 participants 29 participants
48
  85.7%
20
  69.0%
MON Above, Month 2, Missing Number Analyzed 56 participants 29 participants
1
   1.8%
1
   3.4%
MON Above, Month 7, Normal Number Analyzed 55 participants 29 participants
13
  23.6%
7
  24.1%
MON Above, Month 7, Below Number Analyzed 55 participants 29 participants
0
   0.0%
0
   0.0%
MON Above, Month 7, Above Number Analyzed 55 participants 29 participants
42
  76.4%
22
  75.9%
NEU Normal, Month 2, Normal Number Analyzed 152 participants 74 participants
130
  85.5%
60
  81.1%
NEU Normal, Month 2, Below Number Analyzed 152 participants 74 participants
20
  13.2%
6
   8.1%
NEU Normal, Month 2, Above Number Analyzed 152 participants 74 participants
0
   0.0%
0
   0.0%
NEU Normal, Month 2, Missing Number Analyzed 152 participants 74 participants
2
   1.3%
8
  10.8%
NEU Normal, Month 7, Normal Number Analyzed 152 participants 72 participants
135
  88.8%
63
  87.5%
NEU Normal, Month 7, Below Number Analyzed 152 participants 72 participants
14
   9.2%
8
  11.1%
NEU Normal, Month 7, Above Number Analyzed 152 participants 72 participants
3
   2.0%
1
   1.4%
NEU Below, Month 2, Normal Number Analyzed 13 participants 8 participants
10
  76.9%
5
  62.5%
NEU Below, Month 2, Below Number Analyzed 13 participants 8 participants
3
  23.1%
3
  37.5%
NEU Below, Month 2, Above Number Analyzed 13 participants 8 participants
0
   0.0%
0
   0.0%
NEU Below, Month 7, Normal Number Analyzed 12 participants 8 participants
8
  66.7%
6
  75.0%
NEU Below, Month 7, Below Number Analyzed 12 participants 8 participants
3
  25.0%
2
  25.0%
NEU Below, Month 7, Above Number Analyzed 12 participants 8 participants
1
   8.3%
0
   0.0%
PLA Normal, Month 2, Normal Number Analyzed 164 participants 78 participants
158
  96.3%
68
  87.2%
PLA Normal, Month 2, Below Number Analyzed 164 participants 78 participants
3
   1.8%
2
   2.6%
PLA Normal, Month 2, Above Number Analyzed 164 participants 78 participants
3
   1.8%
2
   2.6%
PLA Normal, Month 2, Missing Number Analyzed 164 participants 78 participants
0
   0.0%
6
   7.7%
PLA Normal, Month 7, Normal Number Analyzed 163 participants 76 participants
156
  95.7%
71
  93.4%
PLA Normal, Month 7, Below Number Analyzed 163 participants 76 participants
2
   1.2%
1
   1.3%
PLA Normal, Month 7, Above Number Analyzed 163 participants 76 participants
5
   3.1%
4
   5.3%
PLA Below, Month 2, Normal Number Analyzed 2 participants 3 participants
0
   0.0%
2
  66.7%
PLA Below, Month 2, Below Number Analyzed 2 participants 3 participants
2
 100.0%
1
  33.3%
PLA Below, Month 2, Above Number Analyzed 2 participants 3 participants
0
   0.0%
0
   0.0%
PLA Below, Month 7, Normal Number Analyzed 2 participants 3 participants
1
  50.0%
0
   0.0%
PLA Below, Month 7, Below Number Analyzed 2 participants 3 participants
1
  50.0%
2
  66.7%
PLA Below, Month 7, Above Number Analyzed 2 participants 3 participants
0
   0.0%
0
   0.0%
PLA Below, Month 7, Missing Number Analyzed 2 participants 3 participants
0
   0.0%
1
  33.3%
PLA Above, Month 2, Normal Number Analyzed 3 participants 3 participants
2
  66.7%
1
  33.3%
PLA Above, Month 2, Below Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
PLA Above, Month 2, Above Number Analyzed 3 participants 3 participants
1
  33.3%
2
  66.7%
PLA Above, Month 7, Normal Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
PLA Above, Month 7, Below Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
PLA Above, Month 7, Above Number Analyzed 3 participants 3 participants
3
 100.0%
3
 100.0%
RBC Normal, Month 2, Normal Number Analyzed 154 participants 82 participants
149
  96.8%
75
  91.5%
RBC Normal, Month 2, Below Number Analyzed 154 participants 82 participants
0
   0.0%
0
   0.0%
RBC Normal, Month 2, Above Number Analyzed 154 participants 82 participants
5
   3.2%
2
   2.4%
RBC Normal, Month 2, Missing Number Analyzed 154 participants 82 participants
0
   0.0%
5
   6.1%
RBC Normal, Month 7, Normal Number Analyzed 153 participants 80 participants
148
  96.7%
78
  97.5%
RBC Normal, Month 7, Below Number Analyzed 153 participants 80 participants
2
   1.3%
1
   1.3%
RBC Normal, Month 7, Above Number Analyzed 153 participants 80 participants
3
   2.0%
1
   1.3%
RBC Below, Month 2, Normal Number Analyzed 2 participants 0 participants
2
 100.0%
0
RBC Below, Month 2, Below Number Analyzed 2 participants 0 participants
0
   0.0%
0
RBC Below, Month 2, Above Number Analyzed 2 participants 0 participants
0
   0.0%
0
RBC Below, Month 7, Normal Number Analyzed 2 participants 0 participants
2
 100.0%
0
RBC Below, Month 7, Below Number Analyzed 2 participants 0 participants
0
   0.0%
0
RBC Below, Month 7, Above Number Analyzed 2 participants 0 participants
0
   0.0%
0
RBC Above, Month 2, Normal Number Analyzed 13 participants 2 participants
7
  53.8%
0
   0.0%
RBC Above, Month 2, Below Number Analyzed 13 participants 2 participants
0
   0.0%
0
   0.0%
RBC Above, Month 2, Above Number Analyzed 13 participants 2 participants
6
  46.2%
1
  50.0%
RBC Above, Month 2, Missing Number Analyzed 13 participants 2 participants
0
   0.0%
1
  50.0%
RBC Above, Month 7, Normal Number Analyzed 13 participants 2 participants
7
  53.8%
0
   0.0%
RBC Above, Month 7, Below Number Analyzed 13 participants 2 participants
0
   0.0%
0
   0.0%
RBC Above, Month 7, Above Number Analyzed 13 participants 2 participants
6
  46.2%
1
  50.0%
RBC Above, Month 7, Missing Number Analyzed 13 participants 2 participants
0
   0.0%
1
  50.0%
WBC Normal, Month 2, Normal Number Analyzed 155 participants 75 participants
142
  91.6%
62
  82.7%
WBC Normal, Month 2, Below Number Analyzed 155 participants 75 participants
7
   4.5%
3
   4.0%
WBC Normal, Month 2, Above Number Analyzed 155 participants 75 participants
6
   3.9%
4
   5.3%
WBC Normal, Month 2, Missing Number Analyzed 155 participants 75 participants
0
   0.0%
6
   8.0%
WBC Normal, Month 7, Normal Number Analyzed 154 participants 73 participants
133
  86.4%
66
  90.4%
WBC Normal, Month 7, Below Number Analyzed 154 participants 73 participants
4
   2.6%
2
   2.7%
WBC Normal, Month 7, Above Number Analyzed 154 participants 73 participants
17
  11.0%
4
   5.5%
WBC Normal, Month 7, Missing Number Analyzed 154 participants 73 participants
0
   0.0%
1
   1.4%
WBC Below, Month 2, Normal Number Analyzed 4 participants 2 participants
4
 100.0%
1
  50.0%
WBC Below, Month 2, Below Number Analyzed 4 participants 2 participants
0
   0.0%
1
  50.0%
WBC Below, Month 2, Above Number Analyzed 4 participants 2 participants
0
   0.0%
0
   0.0%
WBC Below, Month 7, Normal Number Analyzed 4 participants 2 participants
4
 100.0%
2
 100.0%
WBC Below, Month 7, Below Number Analyzed 4 participants 2 participants
0
   0.0%
0
   0.0%
WBC Below, Month 7, Above Number Analyzed 4 participants 2 participants
0
   0.0%
0
   0.0%
WBC Above, Month 2, Normal Number Analyzed 10 participants 7 participants
10
 100.0%
7
 100.0%
WBC Above, Month 2, Below Number Analyzed 10 participants 7 participants
0
   0.0%
0
   0.0%
WBC Above, Month 2, Above Number Analyzed 10 participants 7 participants
0
   0.0%
0
   0.0%
WBC Above, Month 7, Normal Number Analyzed 10 participants 7 participants
9
  90.0%
6
  85.7%
WBC Above, Month 7, Below Number Analyzed 10 participants 7 participants
0
   0.0%
0
   0.0%
WBC Above, Month 7, Above Number Analyzed 10 participants 7 participants
1
  10.0%
1
  14.3%
Time Frame Solicited local and general symptoms: during the 7-day (Days0-6) post-vaccination period. Unsolicited adverse events (AEs): during the 30-day (Days 0-29) post-vaccination period. Serious adverse events (SAEs): Throughout the entire study period (active phase and extended safety follow-up): up to Month 12.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cervarix Group Engerix-B Group
Hide Arm/Group Description Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12. Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
All-Cause Mortality
Cervarix Group Engerix-B Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/181 (0.00%)      0/89 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cervarix Group Engerix-B Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/181 (1.66%)      1/89 (1.12%)    
Gastrointestinal disorders     
Crohn’s disease  1  1/181 (0.55%)  1 0/89 (0.00%)  0
Infections and infestations     
Appendicitis  1 [1]  1/175 (0.57%)  1 0/86 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteochondrosis  1 [1]  0/175 (0.00%)  0 1/86 (1.16%)  1
Nervous system disorders     
Epilepsy  1  1/181 (0.55%)  1 0/89 (0.00%)  0
1
Term from vocabulary, MedDRA 9.1
Indicates events were collected by systematic assessment
[1]
This serious adverse event was recorded during the ESFU phase, which only included subjects that could have been contacted by telephone for the Safety follow-up at Month 12, hence the number of participants at risk is different.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cervarix Group Engerix-B Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   170/181 (93.92%)      73/89 (82.02%)    
Gastrointestinal disorders     
Gastrointestinal disorder  1  40/181 (22.10%)  61 14/89 (15.73%)  19
General disorders     
Fatigue  1  82/181 (45.30%)  130 42/89 (47.19%)  61
Pain  1  159/181 (87.85%)  378 39/89 (43.82%)  57
Pyrexia  1  39/181 (21.55%)  56 19/89 (21.35%)  24
Swelling  1  36/181 (19.89%)  56 7/89 (7.87%)  8
Infections and infestations     
Nasopharyngitis  1  12/181 (6.63%)  13 3/89 (3.37%)  3
Musculoskeletal and connective tissue disorders     
Arthralgia  1  31/181 (17.13%)  38 10/89 (11.24%)  13
Myalgia  1  88/181 (48.62%)  142 23/89 (25.84%)  32
Nervous system disorders     
Headache  1  82/181 (45.30%)  131 40/89 (44.94%)  56
Skin and subcutaneous tissue disorders     
Erythema  1  51/181 (28.18%)  87 15/89 (16.85%)  29
Rash  1  16/181 (8.84%)  20 5/89 (5.62%)  5
1
Term from vocabulary, MedDRA 9.1
Indicates events were collected by systematic assessment
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00309166     History of Changes
Other Study ID Numbers: 580299/011
First Submitted: March 28, 2006
First Posted: March 31, 2006
Results First Submitted: December 19, 2016
Results First Posted: September 17, 2018
Last Update Posted: September 17, 2018