Trial Outcomes & Findings for Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males. (NCT NCT00309166)

Last Updated: 2018-09-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

270 participants

Primary outcome timeframe

At Month 7

Results posted on

2018-09-17

Participant Flow

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Participant milestones
Measure	Cervarix Group 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.	Engerix-B Group 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 Study STARTED	181	89
Overall Study COMPLETED	176	86
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Cervarix Group 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.	Engerix-B Group 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 Study Adverse event, non-fatal	1	0
Overall Study Withdrawal by Subject	4	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cervarix Group n=181 Participants 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.	Engerix-B Group n=89 Participants 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 n=270 Participants Total of all reporting groups
Age, Continuous	14.4 Years STANDARD_DEVIATION 2.14 • n=5 Participants	14.4 Years STANDARD_DEVIATION 2.02 • n=7 Participants	14.4 Years STANDARD_DEVIATION 2.10 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	181 Participants n=5 Participants	89 Participants n=7 Participants	270 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · African heritage/African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian-Central/South Asian heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White-Arabic/North African heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White-Caucasian/European heritage	177 Participants n=5 Participants	88 Participants n=7 Participants	265 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Not specified	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 7

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.

Outcome measures

Outcome measures
Measure	Cervarix Group n=163 Participants 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.	Engerix-B Group n=86 Participants 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.
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 HPV-16	163 Participants	1 Participants
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 HPV-18	150 Participants	2 Participants

PRIMARY outcome

Timeframe: At Month 7

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.

Titers were presented as geometric mean titers (GMT).

Outcome measures

Outcome measures
Measure	Cervarix Group n=171 Participants 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.	Engerix-B Group n=86 Participants 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.
Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) HPV-16	22564.8 EL.U/mL Interval 19800.3 to 25715.4	4.2 EL.U/mL Interval 4.0 to 4.5
Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) HPV-18	8460.3 EL.U/mL Interval 7306.1 to 9796.8	3.6 EL.U/mL Interval 3.4 to 3.8

SECONDARY outcome

Timeframe: At Month 2

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.

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.

Outcome measures

Outcome measures
Measure	Cervarix Group n=165 Participants 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.	Engerix-B Group n=86 Participants 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.
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 HPV-16	165 Participants	0 Participants
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 HPV-18	152 Participants	4 Participants

SECONDARY outcome

Timeframe: At Month 2

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.

Titers were presented as GMTs.

Outcome measures

Outcome measures
Measure	Cervarix Group n=173 Participants 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.	Engerix-B Group n=86 Participants 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.
Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) HPV-16	5254.5 EL.U/mL Interval 4704.9 to 5868.2	4.1 EL.U/mL Interval 4.0 to 4.3
Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) HPV-18	3696.9 EL.U/mL Interval 3275.9 to 4172.1	3.7 EL.U/mL Interval 3.5 to 3.8

SECONDARY outcome

Timeframe: Within 7 days (Days 0-6) after each dose and across doses, up to 7 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Cervarix Group n=180 Participants 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.	Engerix-B Group n=88 Participants 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.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Dose 1	149 Participants	25 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, Dose 1	24 Participants	12 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, Dose 1	7 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Dose 2	114 Participants	16 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	2 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, Dose 2	30 Participants	8 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, Dose 2	20 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Dose 3	115 Participants	16 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 3	7 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, Dose 3	33 Participants	9 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 3	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, Dose 3	29 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 3	2 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Across doses	159 Participants	39 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	8 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, Across doses	51 Participants	15 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, Across doses	36 Participants	7 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Within 7 days (Days 0-6) after each dose and across doses, up to 7 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Cervarix Group n=180 Participants 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.	Engerix-B Group n=88 Participants 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.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Gastrointestinal, Dose 1	33 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 1	15 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 2	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria, Dose 2	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Arthralgia, Dose 3	12 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia, Dose 3	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthtralgia, Dose 3	12 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Dose 3	44 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever (axillary), Dose 3	14 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 3	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 3	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 3	8 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Dose 3	30 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 3	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Myalgia, Dose 3	39 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Mylagia, Dose 3	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Rash, Dose 3	3 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Across doses	4 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Across doses	19 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	43 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Rash, Across doses	5 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria, Across doses	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Arthralgia, Dose 1	17 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Athralgia, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Athralgia, Dose 1	10 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Dose 1	51 Participants	32 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	26 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever (axillary), Dose 1	24 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 1	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 1	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Dose 1	51 Participants	21 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	24 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Myalgia, Dose 1	67 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Mylagia, Dose 1	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Mylagia, Dose 1	45 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Rash, Dose 1	8 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Rash, Dose 1	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Urticaria, Dose 1	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Urticaria, Dose 1	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Arthralgia, Dose 2	6 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia, Dose 2	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia, Dose 2	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Dose 2	35 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	21 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever (axillary), Dose 2	14 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 2	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Gastrointestinal, Dose 2	18 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 2	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 2	7 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Dose 2	30 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	14 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Myalgia, Dose 2	35 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Maylagia, Dose 2	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Maylagia, Dose 2	27 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Rash, Dose 2	8 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash, Dose 2	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Rash, Dose 2	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Urticaria, Dose 2	1 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Urticaria, Dose 2	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 3	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 3	30 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 3	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Gastrointestinal, Dose 3	10 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 3	17 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Mylagia, Dose 3	35 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash, Dose 3	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Rash, Dose 3	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Urticaria, Dose 3	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria, Dose 3	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Urticaria, Dose 3	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Arthralgia, Across doses	29 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia, Across doses	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia, Across doses	22 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Across doses	82 Participants	42 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	4 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	52 Participants	33 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever (axillary), Across doses	35 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Across doses	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Across doses	3 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Gastrointestinal, Across doses	40 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Across doses	77 Participants	33 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	5 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Myalgia, Across doses	88 Participants	23 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Mylagia, Across doses	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Mylagia, Across doses	70 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Rash, Across doses	16 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash, Across doses	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Urticaria, Across doses	4 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Urticaria, Across doses	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 30 days (Day 0-29) after any vaccination, up to 7 months

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

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.

Outcome measures

Outcome measures
Measure	Cervarix Group n=181 Participants 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.	Engerix-B Group n=89 Participants 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.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AEs	68 Participants	31 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AEs	5 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AEs	5 Participants	1 Participants

SECONDARY outcome

Timeframe: Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Cervarix Group n=181 Participants 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.	Engerix-B Group n=89 Participants 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.
Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions NOCDs, Month 7	2 Participants	1 Participants
Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions MSCs, Month 7	22 Participants	10 Participants
Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions NOCDs, Month 7 to Month 12	0 Participants	0 Participants
Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions MSCs, Month 7 to Month 12	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)

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.

Outcome measures

Outcome measures
Measure	Cervarix Group n=181 Participants 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.	Engerix-B Group n=89 Participants 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.
Number of Subjects With Serious Adverse Events (SAEs) SAEs, Month 7	2 Participants	0 Participants
Number of Subjects With Serious Adverse Events (SAEs) SAEs, Month 12	1 Participants	1 Participants

SECONDARY outcome

Timeframe: At Month 2 and Month 7, post-vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

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.

Outcome measures

Outcome measures
Measure	Cervarix Group n=172 Participants 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.	Engerix-B Group n=86 Participants 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.
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters CREA Normal, Month 2, Normal	158 Participants	76 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters CREA Normal, Month 2, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Above, Month 2, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters BAS Normal, Month 2, Above	3 Participants	3 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters BAS Normal, Month 7, Above	11 Participants	8 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Above, Month 2, Normal	6 Participants	5 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Below, Month 7, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Above, Month 2, Normal	3 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Above, Month 7, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Above, Month 7, Normal	8 Participants	5 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Above, Month 7, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Above, Month 7, Above	27 Participants	6 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters CREA Normal, Month 2, Above	5 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters CREA Normal, Month 2, Missing	0 Participants	6 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters CREA Normal, Month 7, Normal	159 Participants	79 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters CREA Normal, Month 7, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters CREA Normal, Month 7, Above	2 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters CREA Above, Month 2, Normal	10 Participants	3 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters CREA Above, Month 2, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters CREA Above, Month 2, Above	3 Participants	2 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters CREA Above, Month 7, Normal	10 Participants	5 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters CREA Above, Month 7, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters CREA Above, Month 7, Above	3 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Normal, Month 2, Normal	155 Participants	76 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Normal, Month 2, Below	2 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Normal, Month 2, Above	2 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Normal, Month 2, Missing	0 Participants	5 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Normal, Month 7, Normal	147 Participants	73 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Normal, Month 7, Below	9 Participants	6 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Normal, Month 7, Above	2 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Below, Month 2, Normal	3 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Below, Month 2, Below	1 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Below, Month 2, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Below, Month 7, Normal	2 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Below, Month 7, Below	2 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Above, Month 2, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Above, Month 2, Above	3 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Above, Month 2, Missing	0 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Above, Month 7, Normal	6 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters HEM Above, Month 7, Above	0 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Normal, Month 2, Normal	166 Participants	79 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Normal, Month 2, Below	3 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Normal, Month 2, Above	3 Participants	2 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Normal, Month 2, Missing	0 Participants	5 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Normal, Month 7, Normal	165 Participants	81 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Normal, Month 7, Below	1 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Normal, Month 7, Above	5 Participants	3 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Below, Month 2, Normal	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Below, Month 2, Below	1 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Below, Month 2, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Below, Month 7, Normal	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Below, Month 7, Below	1 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Below, Month 7, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Above, Month 2, Normal	2 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Above, Month 2, Above	2 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Above, Month 2, Missing	0 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Above, Month 7, Normal	2 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Above, Month 7, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters ALT Above, Month 7, Above	1 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters BAS Normal, Month 2, Normal	140 Participants	65 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters BAS Normal, Month 2, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters BAS Normal, Month 2, Missing	3 Participants	8 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters BAS Normal, Month 7, Normal	134 Participants	66 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters BAS Normal, Month 7, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters BAS Above, Month 2, Normal	12 Participants	5 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters BAS Above, Month 2, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters BAS Above, Month 2, Above	6 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters BAS Above, Month 7, Normal	14 Participants	4 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters BAS Above, Month 7, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters BAS Above, Month 7, Above	4 Participants	2 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Normal, Month 2, Normal	102 Participants	48 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Normal, Month 2, Below	4 Participants	2 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Normal, Month 2, Above	17 Participants	10 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Normal, Month 2, Missing	2 Participants	8 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Normal, Month 7, Normal	108 Participants	54 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Normal, Month 7, Below	8 Participants	4 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Normal, Month 7, Above	9 Participants	9 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Below, Month 2, Normal	4 Participants	2 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Below, Month 2, Below	0 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Below, Month 2, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Below, Month 7, Normal	2 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Below, Month 7, Below	2 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Below, Month 7, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Above, Month 2, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters EOS Above, Month 2, Above	30 Participants	6 Participants

SECONDARY outcome

Timeframe: At Month 2 and at Month 7, post-vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

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.

Outcome measures

Outcome measures
Measure	Cervarix Group n=164 Participants 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.	Engerix-B Group n=82 Participants 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.
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Below, Month 2, Normal	1 Participants	3 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Below, Month 7, Below	1 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Below, Month 7, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters NEU Normal, Month 2, Normal	130 Participants	60 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Above, Month 7, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Above, Month 7, Normal	9 Participants	6 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Normal, Month 2, Normal	117 Participants	56 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Normal, Month 2, Below	5 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Normal, Month 2, Above	18 Participants	6 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Normal, Month 2, Missing	2 Participants	8 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Normal, Month 7, Normal	126 Participants	63 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Normal, Month 7, Below	4 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Normal, Month 7, Above	12 Participants	5 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Below, Month 2, Normal	1 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Below, Month 2, Below	2 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Below, Month 2, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Below, Month 7, Normal	2 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Below, Month 7, Below	1 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Below, Month 7, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Above, Month 2, Normal	11 Participants	5 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Above, Month 2, Below	1 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Above, Month 2, Above	8 Participants	5 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Above, Month 7, Normal	11 Participants	8 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Above, Month 7, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters LYM Above, Month 7, Above	8 Participants	2 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Normal, Month 2, Normal	92 Participants	38 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Normal, Month 2, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Normal, Month 2, Above	15 Participants	5 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Normal, Month 2, Missing	1 Participants	7 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Normal, Month 7, Normal	93 Participants	43 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Normal, Month 7, Below	0 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Normal, Month 7, Above	15 Participants	4 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Below, Month 2, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Below, Month 2, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Below, Month 7, Normal	0 Participants	3 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Above, Month 2, Normal	7 Participants	8 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Above, Month 2, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Above, Month 2, Above	48 Participants	20 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Above, Month 2, Missing	1 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Above, Month 7, Normal	13 Participants	7 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Above, Month 7, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters MON Above, Month 7, Above	42 Participants	22 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters NEU Normal, Month 2, Below	20 Participants	6 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters NEU Normal, Month 2, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters NEU Normal, Month 2, Missing	2 Participants	8 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters NEU Normal, Month 7, Normal	135 Participants	63 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters NEU Normal, Month 7, Below	14 Participants	8 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters NEU Normal, Month 7, Above	3 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters NEU Below, Month 2, Normal	10 Participants	5 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters NEU Below, Month 2, Below	3 Participants	3 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters NEU Below, Month 2, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters NEU Below, Month 7, Normal	8 Participants	6 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters NEU Below, Month 7, Below	3 Participants	2 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters NEU Below, Month 7, Above	1 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Normal, Month 2, Normal	158 Participants	68 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Normal, Month 2, Below	3 Participants	2 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Normal, Month 2, Above	3 Participants	2 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Normal, Month 2, Missing	0 Participants	6 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Normal, Month 7, Normal	156 Participants	71 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Normal, Month 7, Below	2 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Normal, Month 7, Above	5 Participants	4 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Below, Month 2, Normal	0 Participants	2 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Below, Month 2, Below	2 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Below, Month 2, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Below, Month 7, Normal	1 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Below, Month 7, Below	1 Participants	2 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Below, Month 7, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Below, Month 7, Missing	0 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Above, Month 2, Normal	2 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Above, Month 2, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Above, Month 2, Above	1 Participants	2 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Above, Month 7, Normal	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Above, Month 7, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters PLA Above, Month 7, Above	3 Participants	3 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Normal, Month 2, Normal	149 Participants	75 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Normal, Month 2, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Normal, Month 2, Above	5 Participants	2 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Normal, Month 2, Missing	0 Participants	5 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Normal, Month 7, Normal	148 Participants	78 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Normal, Month 7, Below	2 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Normal, Month 7, Above	3 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Below, Month 2, Normal	2 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Below, Month 2, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Below, Month 2, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Below, Month 7, Normal	2 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Below, Month 7, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Below, Month 7, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Above, Month 2, Normal	7 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Above, Month 2, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Above, Month 2, Above	6 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Above, Month 2, Missing	0 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Above, Month 7, Normal	7 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Above, Month 7, Above	6 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters RBC Above, Month 7, Missing	0 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Normal, Month 2, Normal	142 Participants	62 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Normal, Month 2, Below	7 Participants	3 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Normal, Month 2, Above	6 Participants	4 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Normal, Month 2, Missing	0 Participants	6 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Normal, Month 7, Normal	133 Participants	66 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Normal, Month 7, Below	4 Participants	2 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Normal, Month 7, Above	17 Participants	4 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Normal, Month 7, Missing	0 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Below, Month 2, Normal	4 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Below, Month 2, Below	0 Participants	1 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Below, Month 2, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Below, Month 7, Normal	4 Participants	2 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Below, Month 7, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Below, Month 7, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Above, Month 2, Normal	10 Participants	7 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Above, Month 2, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Above, Month 2, Above	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Above, Month 7, Below	0 Participants	0 Participants
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters WBC Above, Month 7, Above	1 Participants	1 Participants

Adverse Events

Cervarix Group

Serious events: 3 serious events

Other events: 170 other events

Deaths: 0 deaths

Engerix-B Group

Serious events: 1 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cervarix Group n=181 participants at risk 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.	Engerix-B Group n=89 participants at risk 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.
Nervous system disorders Epilepsy	0.55% 1/181 • Number of events 1 • 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.	0.00% 0/89 • 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.
Gastrointestinal disorders Crohn's disease	0.55% 1/181 • Number of events 1 • 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.	0.00% 0/89 • 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.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/175 • 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.	1.2% 1/86 • Number of events 1 • 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.
Infections and infestations Appendicitis	0.57% 1/175 • Number of events 1 • 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.	0.00% 0/86 • 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.

Other adverse events

Other adverse events
Measure	Cervarix Group n=181 participants at risk 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.	Engerix-B Group n=89 participants at risk 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.
Musculoskeletal and connective tissue disorders Arthralgia	17.1% 31/181 • Number of events 38 • 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.	11.2% 10/89 • Number of events 13 • 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.
Skin and subcutaneous tissue disorders Erythema	28.2% 51/181 • Number of events 87 • 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.	16.9% 15/89 • Number of events 29 • 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.
General disorders Fatigue	45.3% 82/181 • Number of events 130 • 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.	47.2% 42/89 • Number of events 61 • 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.
Gastrointestinal disorders Gastrointestinal disorder	22.1% 40/181 • Number of events 61 • 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.	15.7% 14/89 • Number of events 19 • 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.
Nervous system disorders Headache	45.3% 82/181 • Number of events 131 • 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.	44.9% 40/89 • Number of events 56 • 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.
Musculoskeletal and connective tissue disorders Myalgia	48.6% 88/181 • Number of events 142 • 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.	25.8% 23/89 • Number of events 32 • 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.
Infections and infestations Nasopharyngitis	6.6% 12/181 • Number of events 13 • 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.	3.4% 3/89 • Number of events 3 • 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.
General disorders Pain	87.8% 159/181 • Number of events 378 • 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.	43.8% 39/89 • Number of events 57 • 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.
General disorders Pyrexia	21.5% 39/181 • Number of events 56 • 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.	21.3% 19/89 • Number of events 24 • 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.
Skin and subcutaneous tissue disorders Rash	8.8% 16/181 • Number of events 20 • 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.	5.6% 5/89 • Number of events 5 • 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.
General disorders Swelling	19.9% 36/181 • Number of events 56 • 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.	7.9% 7/89 • Number of events 8 • 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.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER