Trial Outcomes & Findings for Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents (NCT NCT00534638)

NCT ID: NCT00534638

Last Updated: 2019-11-15

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 34412 participants
• Primary outcome timeframe: At the time of Visit 5 (i.e. at 18.5 years of age)
• Results posted on: 2019-11-15

Participant Flow

Immunization phase (Day 0 to Month 12) = adolescents (birth cohorts '92-'95) were vaccinated with Cervarix/Engerix-B. Effectiveness evaluation phase (Visit 5) = the vaccine's impact was assessed on female subjects aged 18.5. At Day 0, Cervarix was not licensed for males;male subjects receiving the vaccine were considered part of a Phase III trial.

34412 subjects were enrolled in the study, out of which 2236 subjects had a subject number allocated, but did not receive a vaccine dose, and 1 subject was excluded due to non-eligibility criteria, hence 32175 subjects were vaccinated and started the study.

Participant milestones

Measure	Cervarix Pooled Group Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Pooled Group Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Study STARTED	14837	17338
Overall Study COMPLETED	8346	5547
Overall Study NOT COMPLETED	6491	11791

Reasons for withdrawal

Measure	Cervarix Pooled Group Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Pooled Group Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Study Withdrawal by Subject	3	4
Overall Study Migrated/moved from study area	13	11
Overall Study Lost to follow-up,incomplete vaccination	83	117
Overall Study Lost to follow-up, complete vaccination	4707	10757
Overall Study Other	1685	902

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cervarix Pooled Group n=14837 Participants Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Pooled Group n=17338 Participants Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Total n=32175 Participants Total of all reporting groups
Age, Continuous	14.1 Years STANDARD_DEVIATION 0.8 • n=5 Participants	14.1 Years STANDARD_DEVIATION 0.8 • n=7 Participants	14.1 Years STANDARD_DEVIATION 0.8 • n=5 Participants
Sex: Female, Male Female	12399 Participants n=5 Participants	8119 Participants n=7 Participants	20518 Participants n=5 Participants
Sex: Female, Male Male	2438 Participants n=5 Participants	9219 Participants n=7 Participants	11657 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · African heritage/African American	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Central/South Asian heritage	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - East Asian heritage	8 Participants n=5 Participants	0 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Japanese heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - South East Asian heritage	13 Participants n=5 Participants	4 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Arabic/North African heritage	31 Participants n=5 Participants	39 Participants n=7 Participants	70 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Caucasian/European heritage	14669 Participants n=5 Participants	17190 Participants n=7 Participants	31859 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Mixed origin	103 Participants n=5 Participants	92 Participants n=7 Participants	195 Participants n=5 Participants

PRIMARY outcome

Timeframe: At the time of Visit 5 (i.e. at 18.5 years of age)

Population: The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.

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

Outcome measures

Measure	Cervarix/Engerix-B A Group n=3629 Participants The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Cervarix/Engerix-B B Group n=4029 Participants The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Group n=3168 Participants In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group	139 Participants	117 Participants	329 Participants

SECONDARY outcome

Timeframe: At the time of Visit 5 (i.e. at 18.5 years of age)

Population: The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.

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

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

Outcome measures

Measure	Cervarix/Engerix-B A Group n=3629 Participants The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Cervarix/Engerix-B B Group n=4029 Participants The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Group In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group	139 Participants	117 Participants	—

SECONDARY outcome

Timeframe: At the time of Visit 5 (i.e. at 18.5 years of age)

Population: The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.

The analysis of overall effectiveness of Cervarix vaccine against genital infection with specific HPV types (16, 18, 31/45, 31/33/45, 31/33/45/51, 31/33/45/51/52, 31/33/35/39/45/51/52/56/58/59/66/68, 16/18/31/33/35/39/45/51/52/56/58/59/66/68, 6, 11, 6/11, 6/11/53/74) was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).

Outcome measures

Measure	Cervarix/Engerix-B A Group n=3629 Participants The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Cervarix/Engerix-B B Group n=4029 Participants The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Group n=3168 Participants In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types HPV-16	88 Participants	85 Participants	227 Participants
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types HPV-18	62 Participants	41 Participants	134 Participants
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types HPV-31/45	97 Participants	93 Participants	182 Participants
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types HPV-31/33/45	175 Participants	173 Participants	271 Participants
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types HPV-31/33/45/51	449 Participants	450 Participants	441 Participants
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types HPV-31/33/45/51/52	563 Participants	585 Participants	532 Participants
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types HPV-31/33/35/39/45/51/52/56/58/59/66/68	923 Participants	961 Participants	776 Participants
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types HPV-16/18/31/33/35/39/45/51/52/56/58/59/66/68	965 Participants	999 Participants	883 Participants
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types HPV-6	192 Participants	183 Participants	139 Participants
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types HPV-11	39 Participants	32 Participants	34 Participants
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types HPV-6/11	221 Participants	204 Participants	165 Participants
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types HPV-6/11/53/74	403 Participants	381 Participants	307 Participants

SECONDARY outcome

Timeframe: At the time of Visit 5 (i.e. at 18.5 years of age)

Population: The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.

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

Outcome measures

Measure	Cervarix/Engerix-B A Group n=3192 Participants The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Cervarix/Engerix-B B Group n=1679 Participants The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Group In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types	9 Participants	27 Participants	—

SECONDARY outcome

Timeframe: At the time of Visit 5 (at 18.5 years of age)

Population: The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.

The analysis of total effectiveness of Cervarix vaccine against oropharyngeal infection with specific HPV types (16, 18, 31/45, 31/33/45, 31/33/45/51, 31/33/45/51/52, 31/33/35/39/45/51/52/56/58/59/66/68, 16/18/31/33/35/39/45/51/52/56/58/59/66/68, 6, 11, 6/11, 6/11/53/74) was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all Cervarix vaccinated subjects from the investigated group (prevalence rate in all Cervarix vaccinated subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).

Outcome measures

Measure	Cervarix/Engerix-B A Group n=3192 Participants The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Cervarix/Engerix-B B Group n=1679 Participants The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Group In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types HPV-16	6 Participants	19 Participants	—
Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types HPV-18	4 Participants	10 Participants	—
Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types HPV-31/45	3 Participants	9 Participants	—
Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types HPV-31/33/45	9 Participants	16 Participants	—
Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types HPV-31/33/45/51	53 Participants	42 Participants	—
Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types HPV-31/33/45/51/52	63 Participants	49 Participants	—
Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types HPV-31/33/35/39/45/51/52/56/58/59/66/68	129 Participants	79 Participants	—
Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types HPV-16/18/31/33/35/39/45/51/52/56/58/59/66/68	136 Participants	95 Participants	—
Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types HPV-6	36 Participants	27 Participants	—
Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types HPV-11	5 Participants	5 Participants	—
Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types HPV-6/11	41 Participants	29 Participants	—
Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types HPV-6/11/53/74	72 Participants	45 Participants	—

SECONDARY outcome

Timeframe: During the 7-day post-vaccination period following each dose and across doses

Population: The analysis was performed on the Total vaccinated cohort (TVC) - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group, with at least one study vaccine administration documented, who were selected for active assessment of safety using diary cards and for whom data were available.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

Outcome measures

Measure	Cervarix/Engerix-B A Group n=603 Participants The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Cervarix/Engerix-B B Group n=1028 Participants The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Group In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Any Pain, Dose 1	463 Participants	157 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Grade 3 Pain, Dose 1	12 Participants	1 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Any Redness, Dose 1	99 Participants	90 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Grade 3 Redness, Dose 1	1 Participants	0 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Any Swelling, Dose 1	61 Participants	29 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Grade 3 Swelling, Dose 1	4 Participants	0 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Any Pain, Dose 2	331 Participants	123 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Grade 3 Pain, Dose 2	9 Participants	1 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Any Redness, Dose 2	88 Participants	59 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Grade 3 Redness, Dose 2	1 Participants	0 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Any Swelling, Dose 2	66 Participants	16 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Grade 3 Swelling, Dose 2	3 Participants	0 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Any Pain, Dose 3	326 Participants	108 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Grade 3 Pain, Dose 3	11 Participants	0 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Any Redness, Dose 3	100 Participants	50 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Grade 3 Redness, Dose 3	2 Participants	0 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Any Swelling, Dose 3	69 Participants	18 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Grade 3 Swelling, Dose 3	3 Participants	0 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Any Pain, Across doses	506 Participants	251 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Grade 3 Pain, Across doses	26 Participants	2 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Any Redness, Across doses	169 Participants	131 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Grade 3 Redness, Across doses	4 Participants	0 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Any Swelling, Across doses	131 Participants	46 Participants	—
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects Grade 3 Swelling, Across doses	8 Participants	0 Participants	—

SECONDARY outcome

Timeframe: During the 7-day post-vaccination period following each dose and across doses

Population: The analysis was performed on the TVC - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group, with at least one study vaccine administration documented, who were selected for active assessment of safety using diary cards and for whom data were available.

Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Measure	Cervarix/Engerix-B A Group n=604 Participants The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Cervarix/Engerix-B B Group n=1028 Participants The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Group In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Fatigue, Dose 1	156 Participants	246 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Fever (axillary), Dose 1	15 Participants	35 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Arthralgia, Dose 1	58 Participants	58 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Arthralgia, Dose 1	0 Participants	1 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Arthralgia, Dose 1	37 Participants	45 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Fatigue, Dose 1	224 Participants	301 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Fatigue, Dose 1	3 Participants	9 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Fever (axillary), Dose 1	3 Participants	4 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Fever (axillary), Dose 1	7 Participants	23 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Gastrointestinal, Dose 1	73 Participants	101 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Gastrointestinal, Dose 1	7 Participants	6 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Gastrointestinal, Dose 1	45 Participants	84 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Headache, Dose 1	178 Participants	255 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Headache, Dose 1	10 Participants	7 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Headache, Dose 1	108 Participants	181 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Myalgia, Dose 1	229 Participants	169 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Myalgia, Dose 1	6 Participants	2 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Myalgia, Dose 1	196 Participants	138 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Rash, Dose 1	13 Participants	17 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Rash, Dose 1	0 Participants	0 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Rash, Dose 1	5 Participants	12 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Urticaria, Dose 1	3 Participants	12 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Urticaria, Dose 1	0 Participants	0 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Urticaria, Dose 1	2 Participants	11 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Arthralgia, Dose 2	41 Participants	38 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Arthralgia, Dose 2	0 Participants	3 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Arthralgia, Dose 2	36 Participants	33 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Fatigue, Dose 2	136 Participants	155 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Fatigue, Dose 2	2 Participants	7 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Fatigue, Dose 2	100 Participants	123 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Fever, Dose 2	19 Participants	28 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Fever, Dose 2	1 Participants	2 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Fever, Dose 2	11 Participants	10 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Gastrointestinal, Dose 2	45 Participants	50 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Gastrointestinal, Dose 2	4 Participants	5 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Gastrointestinal, Dose 2	27 Participants	38 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Headache, Dose 2	101 Participants	144 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Headache, Dose 2	5 Participants	4 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Headache, Dose 2	55 Participants	104 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Myalgia, Dose 2	151 Participants	97 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Myalgia, Dose 2	1 Participants	1 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Myalgia, Dose 2	143 Participants	77 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Rash, Dose 2	9 Participants	14 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Rash, Dose 2	0 Participants	0 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Rash, Dose 2	4 Participants	9 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Urticaria, Dose 2	1 Participants	2 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Urticaria, Dose 2	0 Participants	0 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Urticaria, Dose 2	1 Participants	1 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Arthralgia, Dose 3	53 Participants	33 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Arthralgia, Dose 3	1 Participants	0 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Arthralgia, Dose 3	41 Participants	29 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Fatigue, Dose 3	135 Participants	141 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Fatigue, Dose 3	4 Participants	6 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Fatigue, Dose 3	100 Participants	116 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Fever, Dose 3	15 Participants	27 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Fever, Dose 3	2 Participants	3 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Fever, Dose 3	10 Participants	24 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Gastrointestinal, Dose 3	19 Participants	50 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Gastrointestinal, Dose 3	0 Participants	2 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Gastrointestinal, Dose 3	12 Participants	39 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Headache, Dose 3	101 Participants	123 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Headache, Dose 3	2 Participants	3 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Headache, Dose 3	69 Participants	97 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Myalgia, Dose 3	158 Participants	80 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Myalgia, Dose 3	5 Participants	0 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Myalgia, Dose 3	137 Participants	69 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Rash, Dose 3	11 Participants	9 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Rash, Dose 3	0 Participants	0 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Rash, Dose 3	5 Participants	8 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Urticaria, Dose 3	0 Participants	3 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Urticaria, Dose 3	0 Participants	0 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Urticaria, Dose 3	0 Participants	3 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Arthralgia, Across doses	107 Participants	97 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Arthralgia, Across doses	1 Participants	4 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Arthralgia, Across doses	87 Participants	81 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Fatigue, Across doses	291 Participants	411 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Fatigue, Across doses	7 Participants	21 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Fatigue, Across doses	233 Participants	351 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Fever, Across doses	48 Participants	85 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Fever, Across doses	6 Participants	9 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Fever, Across doses	28 Participants	53 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Gastrointestinal, Across doses	106 Participants	163 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Gastrointestinal, Across doses	11 Participants	13 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Gastrointestinal, Across doses	70 Participants	128 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Headache, Across doses	261 Participants	371 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Headache, Across doses	15 Participants	14 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Headache, Across doses	176 Participants	280 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Myalgia, Across doses	321 Participants	250 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Myalgia, Across doses	12 Participants	3 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Myalgia, Across doses	291 Participants	211 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Rash, Across doses	29 Participants	33 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Rash, Across doses	0 Participants	0 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Rash, Across doses	14 Participants	23 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Any Urticaria, Across doses	4 Participants	15 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Grade 3 Urticaria, Across doses	0 Participants	0 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects Related Urticaria, Across doses	3 Participants	13 Participants	—

SECONDARY outcome

Timeframe: Within the 30-day post-vaccination period

Population: This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available.

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

Measure	Cervarix/Engerix-B A Group n=643 Participants The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Cervarix/Engerix-B B Group n=1047 Participants The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Group In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects Any AEs	157 Participants	202 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects Grade 3 AEs	31 Participants	46 Participants	—
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects Related AEs	12 Participants	19 Participants	—

SECONDARY outcome

Timeframe: Within 30 minutes following each vaccination dose

Population: This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available.

The number of subjects with urticaria/rash assessed within 30 minutes following each vaccine dose are reported. Confirmed urticaria/rash = subjects who reported urticaria/rash within the specified time frame. Not confirmed urticaria/rash = number of subjects who did not report urticaria/rash within the specified time frame.

Outcome measures

Measure	Cervarix/Engerix-B A Group n=643 Participants The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Cervarix/Engerix-B B Group n=1047 Participants The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Group In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects Not confirmed urticaria/rash, Dose 1	643 Participants	1047 Participants	—
Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects Confirmed urticaria/rash, Dose 1	0 Participants	0 Participants	—
Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects Not confirmed urticaria/rash, Dose 2	634 Participants	1042 Participants	—
Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects Confirmed urticaria/rash, Dose 2	0 Participants	0 Participants	—
Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects Not confirmed urticaria/rash, Dose 3	630 Participants	1039 Participants	—
Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects Confirmed urticaria/rash, Dose 3	0 Participants	0 Participants	—
Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects Missing urticaria/rash, Dose 3	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: From Dose 1 (at Day 0) until Month 12

Population: This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available.

MSCs are defined as AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.

Outcome measures

Measure	Cervarix/Engerix-B A Group n=643 Participants The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Cervarix/Engerix-B B Group n=1047 Participants The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Group In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Male Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects	47 Participants	76 Participants	—

SECONDARY outcome

Timeframe: From Dose 1 (at Day 0) until Month 12

Population: The analysis was performed on the TVC - subset of male subjects with active follow-up Month 0-Month 12 for SAEs, which included the male subjects in the Diary Card subset and the remaining Cervarix/Engerix-B A Group male subjects for whom data were available.

Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

Outcome measures

Measure	Cervarix/Engerix-B A Group n=2436 Participants The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Cervarix/Engerix-B B Group n=1267 Participants The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Group In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Male Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects Any SAEs	58 Participants	25 Participants	—
Number of Male Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects Related SAEs	4 Participants	1 Participants	—

SECONDARY outcome

Timeframe: During the entire study period (from Day 0 up to Visit 5 [18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)

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

Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

Outcome measures

Measure	Cervarix/Engerix-B A Group n=14837 Participants The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Cervarix/Engerix-B B Group n=17338 Participants The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Group In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Subjects Reporting SAEs Assessed by the Investigator as Possibly Related to Vaccination	25 Participants	30 Participants	—

SECONDARY outcome

Timeframe: During the entire study period (from day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)

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

NOADs include colitis ulcerative, juvenile arthritis, type 1 diabetes mellitus, coeliac disease and Chron's disease, Basedow's disease, erythema nodosum VIIth nerve paralysis and psoriasis.

Outcome measures

Measure	Cervarix/Engerix-B A Group n=14837 Participants The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Cervarix/Engerix-B B Group n=17338 Participants The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Group In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Subjects With New Onset of Autoimmune Diseases (NOADs), Retrieved From Care Register for Social Welfare and Health Care (HILMO)	149 Participants	180 Participants	—

SECONDARY outcome

Timeframe: During the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)

Population: The analysis was performed on the total number of pregnant subjects reported, part of the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

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

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

Outcome measures

Measure	Cervarix/Engerix-B A Group n=777 Participants The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Cervarix/Engerix-B B Group n=567 Participants The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Group In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO Live infant with no apparent anomaly	254 Participants	183 Participants	—
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO Elective termination with no apparent anomaly	454 Participants	332 Participants	—
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO Ectopic pregnancy	5 Participants	5 Participants	—
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO Spontaneous abortion with no apparent anomaly	62 Participants	45 Participants	—
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO Stillbirth with no apparent congenital anomaly	0 Participants	1 Participants	—
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO Molar pregnancy	2 Participants	1 Participants	—

SECONDARY outcome

Timeframe: At the time of Visit 1 (at Day 0), Visit 4 (at Month 7) and Visit 5 (at 18.5 years of age)

Population: The analysis was performed on the ATP cohort for immunogenicity-Immunogenicity subset, which comprised the same male study subjects from the Cervarix/Engerix-B A Group included in the Diary Card subset, plus approximately 1500 female study subjects from the same Cervarix/Engerix-B A Group, with assay results available at the considered time point.

The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5.

Outcome measures

Measure	Cervarix/Engerix-B A Group n=1163 Participants The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Cervarix/Engerix-B B Group The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Group In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects anti-HPV-16 ≥ 8 EL.U/mL, males (Day 0)	40 Participants	—	—
Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects anti-HPV-16 ≥ 8 EL.U/mL, males (Month 7)	536 Participants	—	—
Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects anti-HPV-16 ≥ 19 EL.U/mL, males (18.5Y)	217 Participants	—	—
Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects anti-HPV-16 ≥ 8 EL.U/mL, females (Day 0)	86 Participants	—	—
Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects anti-HPV-16 ≥ 8 EL.U/mL, females (Month 7)	1163 Participants	—	—
Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects anti-HPV-16 ≥ 19 EL.U/mL, females (18.5Y)	688 Participants	—	—
Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects anti-HPV-18 ≥ 7 EL.U/mL, males (Day 0)	31 Participants	—	—
Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects anti-HPV-18 ≥ 7 EL.U/mL, males (Month 7)	535 Participants	—	—
Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects anti-HPV-18 ≥ 18 EL.U/mL, males (18.5Y)	217 Participants	—	—
Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects anti-HPV-18 ≥ 7 EL.U/mL, females (Day 0)	84 Participants	—	—
Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects anti-HPV-18 ≥ 7 EL.U/mL, females (Month 7)	1160 Participants	—	—
Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects anti-HPV-18 ≥ 18 EL.U/mL, females (18.5Y)	685 Participants	—	—

SECONDARY outcome

Timeframe: At the time of Visit 1 (Day 0), Visit 4 (at Month 7) and at the time of Visit 5 (18.5 years of age)

Population: The analysis was performed on the ATP cohort for immunogenicity-Immunogenicity subset, which comprised the same male study subjects from the Cervarix/Engerix-B A Group included in the Diary Card subset, plus approximately 1500 female study subjects from the same Cervarix/Engerix-B A Group, with assay results available at the considered time point.

The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5.

Outcome measures

Measure	Cervarix/Engerix-B A Group n=1163 Participants The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Cervarix/Engerix-B B Group The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Group In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects anti-HPV-18 ≥ 7 EL.U/mL, males (Month 7)	8583.9 EL.U/mL Interval 7974.7 to 9239.5	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects anti-HPV-16 ≥ 8 EL.U/mL, males (Day 0)	4.5 EL.U/mL Interval 4.3 to 4.6	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects anti-HPV-16 ≥ 8 EL.U/mL, males (Month 7)	23959.1 EL.U/mL Interval 22301.0 to 25740.4	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects anti-HPV-16 ≥ 19 EL.U/mL, males (18.5Y)	2759.5 EL.U/mL Interval 2432.1 to 3130.9	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects anti-HPV-16 ≥ 8 EL.U/mL, females (Day 0)	4.5 EL.U/mL Interval 4.4 to 4.6	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects anti-HPV-16 ≥ 8 EL.U/mL, females (Month 7)	21327.2 EL.U/mL Interval 20338.9 to 22363.5	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects anti-HPV-16 ≥ 19 EL.U/mL, females (18.5Y)	2609.6 EL.U/mL Interval 2444.4 to 2785.9	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects anti-HPV-18 ≥ 7 EL.U/mL, males (Day 0)	3.8 EL.U/mL Interval 3.7 to 4.0	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects anti-HPV-18 ≥ 18 EL.U/mL, males (18.5Y)	837.7 EL.U/mL Interval 727.3 to 964.9	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects anti-HPV-18 ≥ 7 EL.U/mL, females (Day 0)	3.9 EL.U/mL Interval 3.8 to 4.0	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects anti-HPV-18 ≥ 7 EL.U/mL, females (Month 7)	8227.3 EL.U/mL Interval 7847.7 to 8625.4	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects anti-HPV-18 ≥ 18 EL.U/mL, females (18.5Y)	890.0 EL.U/mL Interval 826.2 to 958.7	—	—

Adverse Events

Cervarix Pooled Group

Serious events: 188 serious events

Other events: 506 other events

Deaths: 0 deaths

Engerix-B Pooled Group

Serious events: 152 serious events

Other events: 411 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cervarix Pooled Group n=643 participants at risk；n=14837 participants at risk Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Pooled Group n=1047 participants at risk；n=17338 participants at risk Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Blood and lymphatic system disorders Splenomegaly	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Congenital, familial and genetic disorders Vitello-intestinal duct remnant	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Endocrine disorders Thyroiditis	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Gastrointestinal disorders Abdominal pain	0.01% 2/14837 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Gastrointestinal disorders Colitis ulcerative	0.08% 12/14837 • Number of events 12 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.08% 14/17338 • Number of events 14 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Gastrointestinal disorders Constipation	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Gastrointestinal disorders Crohn's disease	0.05% 7/14837 • Number of events 7 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.09% 15/17338 • Number of events 15 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Gastrointestinal disorders Food poisoning	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Gastrointestinal disorders Proctitis ulcerative	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
General disorders Chest pain	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
General disorders Pyrexia	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Hepatobiliary disorders Cholecystitis	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Immune system disorders Anaphylactic reaction	0.01% 2/14837 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Immune system disorders Hypersensitivity	0.01% 2/14837 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Appendicitis	0.03% 5/14837 • Number of events 5 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.02% 3/17338 • Number of events 3 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Appendicitis perforated	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Bronchitis	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Encephalitis	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 2/17338 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Gastroenteritis bacterial	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Genital infection	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Infectious mononucleosis	0.03% 4/14837 • Number of events 4 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Muscle abscess	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Pelvic infection	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Peritonsillar abscess	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Pneumonia	0.01% 2/14837 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Pneumonia bacterial	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Pyelonephritis	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Salmonellosis	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Sepsis	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Sinusitis	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Sinusitis bacterial	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Tonsillitis	0.03% 4/14837 • Number of events 4 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Alcohol poisoning	0.02% 3/14837 • Number of events 3 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Concussion	0.03% 4/14837 • Number of events 4 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Contusion	0.01% 2/14837 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 2/17338 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Forearm fracture	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Hand fracture	0.01% 2/14837 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Limb injury	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Lower limb fracture	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Muscle rupture	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Neck injury	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Radius fracture	0.01% 2/14837 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Traumatic renal injury	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Injury, poisoning and procedural complications Upper limb fracture	0.01% 2/14837 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.09% 13/14837 • Number of events 13 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.14% 25/17338 • Number of events 25 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 2/17338 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Musculoskeletal and connective tissue disorders Exostosis	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Musculoskeletal and connective tissue disorders Juvenile idiopathic arthritis	0.02% 3/14837 • Number of events 3 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.02% 4/17338 • Number of events 4 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Musculoskeletal and connective tissue disorders Sjogren's syndrome	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Astrocytoma, low grade	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign hydatidiform mole	0.01% 2/14837 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Nervous system disorders Cataplexy	0.01% 2/14837 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Nervous system disorders Cerebral haemorrhage	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Nervous system disorders Epilepsy	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 2/17338 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Nervous system disorders Guillain-barre syndrome	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Nervous system disorders Headache	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Nervous system disorders Multiple sclerosis	0.01% 2/14837 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Nervous system disorders Narcolepsy	0.01% 2/14837 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Nervous system disorders Optic neuritis	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Nervous system disorders Syncope	0.01% 2/14837 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.07% 10/14837 • Number of events 10 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.09% 15/17338 • Number of events 15 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.22% 32/14837 • Number of events 32 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.10% 18/17338 • Number of events 20 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous complete	0.03% 4/14837 • Number of events 4 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 2/17338 • Number of events 3 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous incomplete	0.07% 10/14837 • Number of events 11 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.02% 3/17338 • Number of events 3 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.03% 5/14837 • Number of events 5 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.03% 5/17338 • Number of events 5 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Pregnancy, puerperium and perinatal conditions Peripartum haemorrhage	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Pregnancy, puerperium and perinatal conditions Premature baby	0.07% 11/14837 • Number of events 11 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.03% 6/17338 • Number of events 6 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Pregnancy, puerperium and perinatal conditions Small for dates baby	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Pregnancy, puerperium and perinatal conditions Stillbirth	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Psychiatric disorders Anxiety	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Psychiatric disorders Depression	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Psychiatric disorders Disturbance in social behaviour	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Psychiatric disorders Emotional disorder of childhood	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Psychiatric disorders Hallucination	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Psychiatric disorders Hypnagogic hallucination	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Psychiatric disorders Panic disorder	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Psychiatric disorders Psychotic disorder	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Psychiatric disorders Sleep attacks	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Psychiatric disorders Suicide attempt	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Renal and urinary disorders Tubulointerstitial nephritis and uveitis syndrome	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Reproductive system and breast disorders Testicular torsion	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Respiratory, thoracic and mediastinal disorders Neonatal asphyxia	0.01% 2/14837 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Skin and subcutaneous tissue disorders Acne	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Skin and subcutaneous tissue disorders Dermatitis	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Skin and subcutaneous tissue disorders Henoch-schonlein purpura	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Skin and subcutaneous tissue disorders Stevens-johnson syndrome	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Skin and subcutaneous tissue disorders Urticaria	0.01% 1/14837 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.00% 0/17338 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Vascular disorders Behcet's syndrome	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.01% 2/14837 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 2/17338 • Number of events 2 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Endocrine disorders Basedow's disease	0.00% 0/14837 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	0.01% 1/17338 • Number of events 1 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.

Other adverse events

Measure	Cervarix Pooled Group n=643 participants at risk；n=14837 participants at risk Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Engerix-B Pooled Group n=1047 participants at risk；n=17338 participants at risk Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
General disorders Pain	83.9% 506/603 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	24.4% 251/1028 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
General disorders Redness	28.0% 169/603 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	12.7% 131/1028 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
General disorders Arthralgia	17.7% 107/604 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	9.4% 97/1028 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
General disorders Fatigue	48.2% 291/604 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	40.0% 411/1028 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
General disorders Fever (Axillary)	7.9% 48/604 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	8.3% 85/1028 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
General disorders Gastrointestinal	17.5% 106/604 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	15.9% 163/1028 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
General disorders Headache	43.2% 261/604 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	36.1% 371/1028 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
Infections and infestations Nasopharyngitis	5.1% 33/643 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	1.6% 17/1047 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
General disorders Swelling	21.7% 131/603 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	4.5% 46/1028 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.
General disorders Myalgia	53.1% 321/604 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.	24.3% 250/1028 • Solicited symptoms: during the 7-day post-vaccination period (across doses). Unsolicited AEs: within the 30-day post-vaccination period (across doses). SAEs: during the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5). AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.

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