Trial Outcomes & Findings for Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old (NCT NCT00224484)

Last Updated: 2019-01-07

Results Overview

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

5960 participants

Primary outcome timeframe

From Month 0 to Month 12

Results posted on

2019-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	gD2-AS04 Group Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Study STARTED	2977	1491	1487
Overall Study COMPLETED	2831	1426	1425
Overall Study NOT COMPLETED	146	65	62

Reasons for withdrawal

Reasons for withdrawal
Measure	gD2-AS04 Group Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Overall Study Serious Adverse Event	1	1	0
Overall Study Non-Serious Adverse Event	5	7	3
Overall Study Protocol Violation	2	2	0
Overall Study Withdrawal by Subject	49	18	16
Overall Study Migrated/moved from study area	18	5	5
Overall Study Lost to Follow-up	66	28	36
Overall Study Reason not specified	5	4	2

Baseline Characteristics

Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	gD2-AS04 Group n=2977 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=1491 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group n=1487 Participants Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Total n=5955 Participants Total of all reporting groups
Age, Continuous	13.81 Years STANDARD_DEVIATION 2.21 • n=5 Participants	13.81 Years STANDARD_DEVIATION 2.21 • n=7 Participants	13.83 Years STANDARD_DEVIATION 2.21 • n=5 Participants	13.81 Years STANDARD_DEVIATION 2.21 • n=4 Participants
Sex: Female, Male Female	2977 Participants n=5 Participants	1491 Participants n=7 Participants	1487 Participants n=5 Participants	5955 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized White/Caucasian	2650 Participants n=5 Participants	1340 Participants n=7 Participants	1330 Participants n=5 Participants	5320 Participants n=4 Participants
Race/Ethnicity, Customized Arabic/North African	12 Participants n=5 Participants	13 Participants n=7 Participants	8 Participants n=5 Participants	33 Participants n=4 Participants
Race/Ethnicity, Customized East/South East Asian	16 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	32 Participants n=4 Participants
Race/Ethnicity, Customized South Asian	6 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Race/Ethnicity, Customized American Hispanic	78 Participants n=5 Participants	27 Participants n=7 Participants	34 Participants n=5 Participants	139 Participants n=4 Participants
Race/Ethnicity, Customized Not specified	58 Participants n=5 Participants	22 Participants n=7 Participants	31 Participants n=5 Participants	111 Participants n=4 Participants
Race/Ethnicity, Customized Black	157 Participants n=5 Participants	78 Participants n=7 Participants	71 Participants n=5 Participants	306 Participants n=4 Participants

PRIMARY outcome

Timeframe: From Month 0 to Month 12

Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=2977 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=1491 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group n=1487 Participants Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects With Serious Adverse Events (SAEs)	71 Participants	42 Participants	37 Participants

SECONDARY outcome

Timeframe: Within 7 days (Days 0-6) after each and any vaccination

Population: The analyses were performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed, who received at least one dose of the study vaccine and for whom data were available.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = greater than (\>) 30mm diameter and persisting more than 24 hours.

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=2970 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=1491 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group n=1484 Participants Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Any, Dose 1	2120 Participants	508 Participants	247 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Grade 3, Dose 1	106 Participants	9 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, Any, Dose 1	598 Participants	125 Participants	103 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, Grade 3, Dose 1	36 Participants	3 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, Any, Dose 1	464 Participants	66 Participants	50 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, Grade 3, Dose 1	36 Participants	1 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Any, Dose 2	1685 Participants	389 Participants	189 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Grade 3, Dose 2	90 Participants	9 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, Any, Dose 2	582 Participants	95 Participants	70 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, Grade 3, Dose 2	41 Participants	0 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, Any, Dose 2	499 Participants	38 Participants	31 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, Grade 3, Dose 2	49 Participants	0 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Any, Dose 3	1729 Participants	377 Participants	161 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Grade 3, Dose 3	137 Participants	12 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, Any, Dose 3	567 Participants	80 Participants	62 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, Grade 3, Dose 3	51 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, Any, Dose 3	540 Participants	46 Participants	32 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, Grade 3, Dose 3	47 Participants	0 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Any, Across doses	2529 Participants	787 Participants	407 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Grade 3, Across doses	278 Participants	26 Participants	12 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, Any, Across doses	1120 Participants	222 Participants	174 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, Grade 3, Across doses	107 Participants	3 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, Any, Across doses	979 Participants	125 Participants	90 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, Grade 3, Across doses	108 Participants	1 Participants	7 Participants

SECONDARY outcome

Timeframe: Within 7 days (Days 0-6) after each and any vaccination

Assessed solicited general symptoms were arthralgia, fatigue, headache, malaise, rash, temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\] and urticaria. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 arthralgia, fatigue, headache, malaise, rash = general symptom that prevented normal activity. Grade 3 temperature = greater than 39 degrees Celsius (°C). Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = general symptom assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=2970 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=1491 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group n=1484 Participants Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Related, Dose 1	530 Participants	232 Participants	239 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Related, Across doses	875 Participants	408 Participants	364 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Grade 3, Across doses	113 Participants	47 Participants	34 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Malaise, Any, Across doses	834 Participants	362 Participants	347 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Arthralgia, Any, Dose 1	375 Participants	141 Participants	122 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Arthralgia, Related, Dose 1	281 Participants	103 Participants	83 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Arthralgia, Grade 3, Dose 1	23 Participants	5 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Any, Dose 1	864 Participants	377 Participants	384 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Related, Dose 1	603 Participants	246 Participants	247 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Grade 3, Dose 1	51 Participants	24 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Urticaria, Grade 3, Dose 1	4 Participants	0 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Any, Dose 1	836 Participants	379 Participants	395 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Grade 3, Dose 1	47 Participants	18 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Malaise, Any, Dose 1	515 Participants	213 Participants	225 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Malaise, Related, Dose 1	354 Participants	138 Participants	146 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Malaise, Grade 3, Dose 1	48 Participants	18 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Rash, Any, Dose 1	68 Participants	29 Participants	23 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Rash, Related, Dose 1	37 Participants	13 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Rash, Grade 3, Dose 1	1 Participants	1 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Temperature (Orally), Any, Dose 1	122 Participants	59 Participants	63 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Temperature(Orally), Related, Dose 1	68 Participants	21 Participants	31 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Temperature(Orally), Grade 3, Dose 1	6 Participants	5 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Urticaria, Any, Dose 1	27 Participants	10 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Urticaria, Related, Dose 1	18 Participants	3 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Arthralgia, Any, Dose 2	259 Participants	102 Participants	54 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Arthralgia, Related, Dose 2	219 Participants	77 Participants	39 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Any, Across doses	1240 Participants	579 Participants	549 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Arthralgia, Grade 3, Dose 2	24 Participants	6 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Any, Dose 2	566 Participants	226 Participants	233 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Related, Dose 2	427 Participants	157 Participants	163 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Grade 3, Dose 2	40 Participants	9 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Any, Dose 2	579 Participants	282 Participants	245 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Related, Dose 2	387 Participants	192 Participants	157 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Grade 3, Dose 2	44 Participants	15 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Malaise, Any, Dose 2	340 Participants	151 Participants	124 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Malaise, Related, Dose 2	240 Participants	103 Participants	88 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Malaise, Grade 3, Dose 2	42 Participants	17 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Rash, Any, Dose 2	57 Participants	16 Participants	20 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Rash, Related, Dose 2	39 Participants	10 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Rash, Grade 3, Dose 2	2 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Temperature(Orally), Any, Dose 2	126 Participants	58 Participants	55 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Temperature(Orally), Related, Dose 2	63 Participants	17 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Temperature(Orally), Grade 3, Dose 2	8 Participants	2 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Urticaria, Any, Dose 2	14 Participants	9 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Urticaria, Related, Dose 2	11 Participants	6 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Urticaria, Grade 3, Dose 2	1 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Arthralgia, Any, Dose 3	239 Participants	77 Participants	64 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Arthralgia, Related, Dose 3	210 Participants	56 Participants	50 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Arthralgia, Grade 3, Dose 3	23 Participants	2 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Any, Dose 3	539 Participants	213 Participants	201 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Related, Dose 3	429 Participants	158 Participants	143 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Grade 3, Dose 3	32 Participants	13 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Any, Dose 3	513 Participants	224 Participants	199 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Related, Dose 3	376 Participants	155 Participants	123 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Grade 3, Dose 3	31 Participants	14 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Malaise, Any, Dose 3	321 Participants	112 Participants	118 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Malaise, Related, Dose 3	248 Participants	77 Participants	81 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Malaise, Grade 3, Dose 3	39 Participants	10 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Rash, Any, Dose 3	34 Participants	10 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Rash, Related, Dose 3	26 Participants	3 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Rash, Grade 3, Dose 3	3 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Temperature (Orally), Any, Dose 3	163 Participants	55 Participants	69 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Temperature(Orally), Related, Dose 3	84 Participants	30 Participants	25 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Temperature(Orally), Grade 3, Dose 3	11 Participants	1 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Urticaria, Any, Dose 3	16 Participants	10 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Urticaria, Related, Dose 3	11 Participants	7 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Urticaria, Grade 3, Dose 3	4 Participants	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Arthralgia, Any, Across doses	585 Participants	233 Participants	192 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Arthralgia, Related, Across doses	482 Participants	183 Participants	139 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Arthralgia, Grade 3, Across doses	62 Participants	13 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Any, Across doses	1176 Participants	524 Participants	526 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Related, Across doses	913 Participants	382 Participants	376 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Grade 3, Across doses	113 Participants	45 Participants	38 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Malaise, Related, Across doses	611 Participants	253 Participants	237 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Malaise, Grade 3, Across doses	118 Participants	41 Participants	31 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Rash, Any, Across doses	141 Participants	46 Participants	51 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Rash, Related, Across doses	93 Participants	20 Participants	35 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Rash, Grade 3, Across doses	6 Participants	2 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Temperature (Orally), Any, Across doses	360 Participants	158 Participants	167 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Temperature (Orally), Related, Across doses	193 Participants	65 Participants	77 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Temperature (Orally), Grade 3, Across doses	23 Participants	8 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Urticaria, Any, Across doses	50 Participants	25 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Urticaria, Related, Across doses	37 Participants	15 Participants	21 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Urticaria, Grade 3, Across doses	9 Participants	2 Participants	5 Participants

SECONDARY outcome

Timeframe: Within 30 days (Day 0-29) after any vaccination

Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine 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 = event which prevented normal, everyday activities. In adults/ adolescents, such an AE would, for example, prevent attendance at work/ school and would necessitate the administration of corrective therapy. Related = event assessed by the investigator as causally related to study vaccination.

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=2977 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=1491 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group n=1487 Participants Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AEs	1325 Participants	676 Participants	667 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AEs	154 Participants	68 Participants	83 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AEs	313 Participants	136 Participants	128 Participants

SECONDARY outcome

Timeframe: Within the 30 Day (Day 0-29) post-vaccination period

Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=2977 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=1491 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group n=1487 Participants Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects With Unsolicited Adverse Events (AEs) With Medically Attended Visits	585 Participants	297 Participants	298 Participants

SECONDARY outcome

Timeframe: During the active phase (up to Month 12)

Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.

NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=2977 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=1491 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group n=1487 Participants Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects With New Onset Chronic Diseases (NOCD)	23 Participants	10 Participants	11 Participants

SECONDARY outcome

Timeframe: At months 7 and 12

Population: The analyses were performed on a subset of subjects from the Total Vaccinated cohort, which included subjects who received at least one dose of the study vaccine and for whom data were available.

Assessed parameters were alanine aminotransferase (ALT), creatinine (CREA), haematocrit (Hct), platelets (PLA), red blood cells (RBC), urea and white blood cells (WBC). A subset of subjects was formed for these analyses. Subjects were categorized according to their results at pre-vaccination at Month 0 (PRE) which were normal, above normal or below the normal range. Per parameter and range, it was assessed whether laboratory values of the subjects were normal, above normal or below the normal range at other timepoints. This outcome presents ALT results.

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=530 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=257 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group n=273 Participants Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE NORMAL, M12- BELOW	4 Participants	1 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE NORMAL, M12- ABOVE	7 Participants	5 Participants	4 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE BELOW, M7- BELOW	0 Participants	3 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE BELOW, M12- ABOVE	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE ABOVE, M7- ABOVE	3 Participants	2 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE ABOVE, M7- MISSING	4 Participants	3 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE ABOVE, M12- NORMAL	4 Participants	5 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE ABOVE, M12- BELOW	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE ABOVE, M12- ABOVE	5 Participants	3 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE ABOVE, M12- MISSING	3 Participants	1 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE NORMAL, M7- NORMAL	519 Participants	249 Participants	268 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE NORMAL, M7- BELOW	2 Participants	1 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE NORMAL, M7- ABOVE	8 Participants	2 Participants	4 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE NORMAL, M7- MISSING	1 Participants	1 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE NORMAL, M12- NORMAL	514 Participants	246 Participants	259 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE NORMAL, M12- MISSING	4 Participants	5 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE BELOW, M7- NORMAL	4 Participants	1 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE BELOW, M7- ABOVE	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE BELOW, M12- NORMAL	4 Participants	2 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE ABOVE, M7- BELOW	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE BELOW, M12- BELOW	0 Participants	2 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE BELOW, M12- MISSING	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed ALT, PRE ABOVE, M7- NORMAL	4 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: At months 7 and 12

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=586 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=282 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group n=300 Participants Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE NORMAL, M7- MISSING	4 Participants	3 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE NORMAL, M12- MISSING	2 Participants	5 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE BELOW, M7- NORMAL	12 Participants	4 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE BELOW, M7- BELOW	31 Participants	19 Participants	10 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE BELOW, M12- BELOW	20 Participants	10 Participants	8 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE ABOVE, M7- BELOW	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE ABOVE, M7- ABOVE	22 Participants	16 Participants	12 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE ABOVE, M12- NORMAL	12 Participants	4 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE ABOVE, M12- BELOW	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE ABOVE, M12- ABOVE	24 Participants	17 Participants	15 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE ABOVE, M12- MISSING	1 Participants	0 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE NORMAL, M7- NORMAL	543 Participants	268 Participants	284 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE NORMAL, M7- BELOW	14 Participants	5 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE NORMAL, M7- ABOVE	25 Participants	6 Participants	9 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE NORMAL, M12- NORMAL	551 Participants	257 Participants	275 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE NORMAL, M12- BELOW	11 Participants	7 Participants	6 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE NORMAL, M12- ABOVE	19 Participants	13 Participants	10 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE BELOW, M7- ABOVE	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE BELOW, M7- MISSING	0 Participants	0 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE BELOW, M12- NORMAL	21 Participants	12 Participants	6 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE BELOW, M12- ABOVE	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed CREA, PRE ABOVE, M7- NORMAL	15 Participants	4 Participants	11 Participants

SECONDARY outcome

Timeframe: At months 7 and 12

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=611 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=295 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group n=311 Participants Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE BELOW, M12- BELOW	13 Participants	4 Participants	5 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE NORMAL, M7- NORMAL	562 Participants	279 Participants	287 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE NORMAL, M7- BELOW	34 Participants	11 Participants	15 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE NORMAL, M7- ABOVE	8 Participants	2 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE NORMAL, M7- MISSING	7 Participants	2 Participants	6 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE NORMAL, M12- NORMAL	562 Participants	275 Participants	276 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE NORMAL, M12- BELOW	25 Participants	11 Participants	17 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE NORMAL, M12- ABOVE	12 Participants	2 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE NORMAL, M12- MISSING	8 Participants	7 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE BELOW, M7- NORMAL	20 Participants	8 Participants	10 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE BELOW, M7- BELOW	10 Participants	5 Participants	4 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE BELOW, M7- ABOVE	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE BELOW, M7- MISSING	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE BELOW, M12- NORMAL	17 Participants	9 Participants	9 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE BELOW, M12- ABOVE	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE BELOW, M12- MISSING	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE ABOVE, M7- NORMAL	11 Participants	8 Participants	8 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE ABOVE, M7- BELOW	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE ABOVE, M7- ABOVE	3 Participants	2 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE ABOVE, M7- MISSING	0 Participants	1 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE ABOVE, M12- NORMAL	11 Participants	8 Participants	9 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE ABOVE, M12- BELOW	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE ABOVE, M12- ABOVE	2 Participants	2 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed Hct, PRE ABOVE, M12- MISSING	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At months 7 and 12

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=608 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=296 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group n=307 Participants Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE NORMAL, M7- NORMAL	576 Participants	286 Participants	292 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE NORMAL, M7- BELOW	5 Participants	1 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE NORMAL, M7- ABOVE	20 Participants	4 Participants	5 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE NORMAL, M7- MISSING	7 Participants	3 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE NORMAL, M12- NORMAL	579 Participants	278 Participants	284 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE NORMAL, M12- ABOVE	12 Participants	9 Participants	5 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE NORMAL, M12- MISSING	9 Participants	8 Participants	10 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE BELOW, M7- NORMAL	2 Participants	1 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE BELOW, M7- BELOW	5 Participants	2 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE BELOW, M7- ABOVE	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE BELOW, M7- MISSING	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE BELOW, M12- NORMAL	2 Participants	2 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE BELOW, M12- BELOW	4 Participants	1 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE BELOW, M12- ABOVE	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE BELOW, M12- MISSING	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE ABOVE, M7- NORMAL	29 Participants	11 Participants	14 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE ABOVE, M7- BELOW	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE ABOVE, M7- ABOVE	6 Participants	8 Participants	11 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE ABOVE, M12- NORMAL	26 Participants	14 Participants	18 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE ABOVE, M12- ABOVE	9 Participants	4 Participants	6 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE NORMAL, M12- BELOW	3 Participants	1 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE ABOVE, M12- BELOW	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed PLA, PRE ABOVE, M12- MISSING	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At months 7 and 12

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=607 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=300 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group n=312 Participants Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE NORMAL, M12- ABOVE	17 Participants	8 Participants	9 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE NORMAL, M7- NORMAL	580 Participants	284 Participants	295 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE NORMAL, M12- NORMAL	574 Participants	281 Participants	280 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE NORMAL, M12- BELOW	5 Participants	4 Participants	9 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE NORMAL, M12- MISSING	7 Participants	7 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE BELOW, M7- NORMAL	10 Participants	8 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE BELOW, M12- BELOW	9 Participants	3 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE ABOVE, M7- NORMAL	19 Participants	7 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE NORMAL, M7- BELOW	15 Participants	8 Participants	8 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE NORMAL, M7- ABOVE	6 Participants	3 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE NORMAL, M7- MISSING	6 Participants	3 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE ABOVE, M7- MISSING	2 Participants	1 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE ABOVE, M12- NORMAL	17 Participants	5 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE BELOW, M7- BELOW	11 Participants	2 Participants	6 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE BELOW, M7- ABOVE	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE BELOW, M12- NORMAL	12 Participants	7 Participants	6 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE BELOW, M12- ABOVE	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE ABOVE, M7- BELOW	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE ABOVE, M7- ABOVE	5 Participants	2 Participants	4 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE ABOVE, M12- BELOW	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE ABOVE, M12- ABOVE	7 Participants	3 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed RBC, PRE ABOVE, M12- MISSING	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: At months 7 and 12

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=651 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=310 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group n=329 Participants Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE BELOW, M7- ABOVE	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE BELOW, M12- NORMAL	10 Participants	6 Participants	8 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE BELOW, M12- BELOW	2 Participants	3 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE ABOVE, M7- BELOW	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE NORMAL, M7- ABOVE	2 Participants	2 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE NORMAL, M7- MISSING	4 Participants	1 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE NORMAL, M12- MISSING	4 Participants	4 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE NORMAL, M7- NORMAL	632 Participants	304 Participants	316 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE NORMAL, M7- BELOW	13 Participants	3 Participants	9 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE NORMAL, M12- NORMAL	615 Participants	301 Participants	304 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE NORMAL, M12- BELOW	18 Participants	5 Participants	10 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE NORMAL, M12- ABOVE	6 Participants	0 Participants	3 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE BELOW, M7- NORMAL	7 Participants	7 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE BELOW, M7- BELOW	2 Participants	3 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE BELOW, M12- ABOVE	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE BELOW, M12- MISSING	0 Participants	2 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE ABOVE, M7- NORMAL	3 Participants	3 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE ABOVE, M7- ABOVE	2 Participants	1 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE ABOVE, M12- NORMAL	5 Participants	3 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE ABOVE, M12- BELOW	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed UREA, PRE ABOVE, M12- ABOVE	0 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: At months 7 and 12

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=579 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=274 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group n=286 Participants Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE NORMAL, M7- BELOW	34 Participants	23 Participants	17 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE BELOW, M7- ABOVE	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE BELOW, M12- NORMAL	41 Participants	20 Participants	16 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE BELOW, M12- BELOW	20 Participants	10 Participants	12 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE NORMAL, M7- ABOVE	6 Participants	4 Participants	9 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE NORMAL, M7- NORMAL	534 Participants	243 Participants	253 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE NORMAL, M7- MISSING	5 Participants	1 Participants	7 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE NORMAL, M12- NORMAL	525 Participants	247 Participants	251 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE NORMAL, M12- BELOW	31 Participants	13 Participants	17 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE NORMAL, M12- ABOVE	14 Participants	9 Participants	9 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE NORMAL, M12- MISSING	7 Participants	5 Participants	5 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE BELOW, M7- NORMAL	40 Participants	20 Participants	19 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE BELOW, M7- BELOW	22 Participants	13 Participants	17 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE BELOW, M7- MISSING	2 Participants	2 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE BELOW, M12- ABOVE	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE BELOW, M12- MISSING	1 Participants	2 Participants	2 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE ABOVE, M7- NORMAL	6 Participants	7 Participants	10 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE ABOVE, M7- BELOW	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE ABOVE, M7- ABOVE	6 Participants	5 Participants	4 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE ABOVE, M12- NORMAL	4 Participants	9 Participants	11 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE ABOVE, M12- BELOW	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Laboratory Parameters Assessed WBC, PRE ABOVE, M12- ABOVE	8 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Starting from Day 30 until the end of study (Month 18)

Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=2977 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=1491 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group n=1487 Participants Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects With Unsolicited Adverse Events (AEs) With Medically Attended Visits	397 Participants	201 Participants	188 Participants

SECONDARY outcome

Timeframe: During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18)

Population: The analyses were performed on the Total Vaccinated cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available. For the purpose of this analysis, the subjects from Havrix Group and Saline group were pooled into one group: Pooled Group.

MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled.

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=2977 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=2978 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects With Medically Significant Conditions (MSC)	69 Participants	73 Participants	—

SECONDARY outcome

Timeframe: During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18)

NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. For outcomes covering the ESFU period, the Havrix Group and Saline Group were pooled.

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=2977 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=2978 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects With New Onset Chronic Diseases (NOCD)	1 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Up to month 18 (during active phase and ESFU period)

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=2977 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=2978 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Number of Subjects With Serious Adverse Events (SAEs)	90 Participants	100 Participants	—

SECONDARY outcome

Timeframe: At months 0, 7 and 12

Population: The analysis was performed on the ATP cohort for immunogenicity, in a predefined immunogenicity subset of HSV vaccine recipients (gD2-AS04 Group) who underwent assessment of biochemical and hematological parameters. Data from participants in the "Havrix Group" and "Saline Group" were not collected.

Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL). Analysis was based on an immunogenicity subset, stratified by initial serostatus: HSV seronegative (-)/ seropositive (+), this included gD2-AS04 vaccine recipients, as follows: HSV 1 and HSV 2 seronegative (HSV1-/2-) and HSV 1 seropositive and HSV 2 seronegative (HSV1+/2-)

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=386 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Anti-glycoprotein D (Anti-gD) Antibody Concentrations HSV1-2-, PRE	23.0 EU/mL Interval 21.7 to 24.4	—	—
Anti-glycoprotein D (Anti-gD) Antibody Concentrations HSV1-2-, M7	7808.6 EU/mL Interval 7185.3 to 8485.9	—	—
Anti-glycoprotein D (Anti-gD) Antibody Concentrations HSV1-2-, M12	2408.9 EU/mL Interval 2200.8 to 2636.7	—	—
Anti-glycoprotein D (Anti-gD) Antibody Concentrations HSV1+2-, PRE	1702.1 EU/mL Interval 1440.6 to 2011.0	—	—
Anti-glycoprotein D (Anti-gD) Antibody Concentrations HSV1+2-, M7	10344.1 EU/mL Interval 9552.2 to 11201.5	—	—
Anti-glycoprotein D (Anti-gD) Antibody Concentrations HSV1+2-, M12	6411.8 EU/mL Interval 5820.8 to 7062.9	—	—

SECONDARY outcome

Timeframe: At months 0, 7 and 12

Population: The analyses were performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects included in the immunogenicity subset for whom data concerning immunogenicity outcome measures were available (for whom assay results were available for antibodies against the study vaccine antigen component after Vaccination).

Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL). The subset of subjects used for this analysis was 50% of the pre-defined subset of subjects that underwent assessment of biochemical and hematological parameters.

Outcome measures

Outcome measures
Measure	gD2-AS04 Group n=303 Participants Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Havrix Group n=128 Participants Female subjects aged 10-17 years, who received 3 doses of Havrix™, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Saline Group n=151 Participants Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Anti-deacylated Monophosphoryl Lipid A (Anti-MPL) Antibody Concentrations Anti-MPL, PRE	195.2 EU/mL Interval 172.6 to 220.8	168.3 EU/mL Interval 138.3 to 204.7	198.4 EU/mL Interval 166.4 to 236.5
Anti-deacylated Monophosphoryl Lipid A (Anti-MPL) Antibody Concentrations Anti-MPL, M7	801.9 EU/mL Interval 722.7 to 889.7	152.7 EU/mL Interval 125.6 to 185.6	190.7 EU/mL Interval 159.7 to 227.7
Anti-deacylated Monophosphoryl Lipid A (Anti-MPL) Antibody Concentrations Anti-MPL, M12	537.4 EU/mL Interval 488.9 to 590.8	193.8 EU/mL Interval 161.2 to 233.0	232.9 EU/mL Interval 198.3 to 273.5

Adverse Events

Group GD2-AS04

Serious events: 71 serious events

Other events: 2718 other events

Deaths: 0 deaths

Group Havrix

Serious events: 42 serious events

Other events: 1210 other events

Deaths: 0 deaths

Group Saline

Serious events: 37 serious events

Other events: 1082 other events

Deaths: 0 deaths

GD2-AS04 (ESFU) Group

Serious events: 90 serious events

Other events: 0 other events

Deaths: 0 deaths

Pooled Group

Serious events: 100 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group GD2-AS04 n=2977 participants at risk Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Group Havrix n=1491 participants at risk Female subjects aged 10-17 years, who received 3 doses of Havrix™ vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Group Saline n=1487 participants at risk Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	GD2-AS04 (ESFU) Group n=2977 participants at risk Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Pooled Group n=2978 participants at risk Pooled group of subjects 10-17 years of age from Havrix and Saline groups, included in the Extended Safety Follow Up (ESFU) period.
Blood and lymphatic system disorders Anaemia	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Blood and lymphatic system disorders Lymphadenitis	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Cardiac disorders Sinus bradycardia	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Cardiac disorders Tachycardia	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Endocrine disorders Hyperthyroidism	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Eye disorders Maculopathy	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Gastrointestinal disorders Abdominal pain	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Gastrointestinal disorders Abdominal pain lower	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Gastrointestinal disorders Gastritis	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Gastrointestinal disorders Inguinal hernia	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Gastrointestinal disorders Lip swelling	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Gastrointestinal disorders Peritonitis	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
General disorders Cyst	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
General disorders Granuloma	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
General disorders Hypothermia	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Hepatobiliary disorders Cholelithiasis	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Immune system disorders Hypersensitivity	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Acute tonsillitis	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Appendicitis	0.30% 9/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.20% 3/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.20% 3/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.37% 11/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.27% 8/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Bronchitis	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Carbuncle	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Cellulitis	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Chronic tonsillitis	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Folliculitis	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Gastroenteritis	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Gastroenteritis viral	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Herpes zoster	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Infectious mononucleosis	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.10% 3/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Influenza	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Meningitis viral	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Peritonsillar abscess	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Pharyngotonsillitis	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.13% 2/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Pilonidal cyst	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Pneumonia	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Pyelonephritis	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Salpingitis	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Sinusitis	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.13% 2/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.10% 3/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Tonsillitis	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.10% 3/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Tracheobronchitis	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Urinary tract infection	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Animal bite	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Concussion	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.10% 3/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Contusion	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Fracture	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Hand fracture	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Humerus fracture	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Joint dislocation	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Joint injury	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Ligament rupture	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Lower limb fracture	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Overdose	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Poisoning	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Road traffic accident	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Spinal compression fracture	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Cystitis	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Tibia fracture	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Metabolism and nutrition disorders Anorexia	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Metabolism and nutrition disorders Dehydration	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Musculoskeletal and connective tissue disorders Arthralgia	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Nervous system disorders Convulsion	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Nervous system disorders Dyskinesia	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Nervous system disorders Epilepsy	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Nervous system disorders Facial paresis	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Nervous system disorders Headache	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Nervous system disorders Migraine	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.13% 2/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Nervous system disorders Neuropathy peripheral	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Nervous system disorders Painful response to normal stimuli	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Nervous system disorders Peripheral nerve lesion	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Nervous system disorders Syncope	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.13% 2/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.27% 4/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.24% 7/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous incomplete	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Psychiatric disorders Abnormal behaviour	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Psychiatric disorders Agression	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Psychiatric disorders Alcohol abuse	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Psychiatric disorders Anorexia nervosa	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Psychiatric disorders Bipolar disorder	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Psychiatric disorders Depression	0.20% 6/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.13% 2/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.27% 8/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.17% 5/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Psychiatric disorders Drug abuse	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.13% 2/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Psychiatric disorders Hallucination	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Psychiatric disorders Intentional self-injury	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Psychiatric disorders Mental disorder	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Psychiatric disorders Psychotic disorder	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Psychiatric disorders Schizophrenia	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Psychiatric disorders Suicidal ideation	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Psychiatric disorders Suicide attempt	0.17% 5/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.17% 5/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Renal and urinary disorders Nephrolithiasis	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Renal and urinary disorders Nephrotic syndrome	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Reproductive system and breast disorders Dysmenorrhoea	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Reproductive system and breast disorders Haemorrhagic ovarian cyst	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Reproductive system and breast disorders Ovarian cyst	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Reproductive system and breast disorders Ovarian cyst ruptured	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Respiratory, thoracic and mediastinal disorders Asthma	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Skin and subcutaneous tissue disorders Urticaria	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 1/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Encephalitis viral	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Fusarium infection	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Incision site infection	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Meningitis aseptic	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Pyelonephritis acute	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Salmonellosis	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Meniscus lesion	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Therapeutic agent toxicity	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Vertebral injury	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Injury, poisoning and procedural complications Wound	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.07% 2/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Nervous system disorders Brain oedema	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Nervous system disorders Paraparesis	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Nervous system disorders Syncope vasovagal	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous complete	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Psychiatric disorders Anxiety disorder	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Psychiatric disorders Conversion disorder	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Reproductive system and breast disorders Endometriosis	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Acute sinusitis	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.00% 0/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	0.03% 1/2978 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.

Other adverse events

Other adverse events
Measure	Group GD2-AS04 n=2977 participants at risk Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Group Havrix n=1491 participants at risk Female subjects aged 10-17 years, who received 3 doses of Havrix™ vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Group Saline n=1487 participants at risk Female subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	GD2-AS04 (ESFU) Group n=2977 participants at risk Female subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.	Pooled Group n=2978 participants at risk Pooled group of subjects 10-17 years of age from Havrix and Saline groups, included in the Extended Safety Follow Up (ESFU) period.
Infections and infestations Nasopharyngitis	4.9% 147/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	5.0% 75/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	5.4% 81/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
Infections and infestations Upper respiratory tract infection	5.1% 151/2977 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	3.4% 50/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	4.6% 69/1487 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
General disorders Pain	85.2% 2529/2970 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	52.8% 787/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	27.4% 407/1484 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
General disorders Redness	37.7% 1120/2970 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	14.9% 222/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	11.7% 174/1484 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
General disorders Swelling	33.0% 979/2970 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	8.4% 125/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	6.1% 90/1484 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
General disorders Arthralgia	19.7% 585/2970 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	15.6% 233/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	12.9% 192/1484 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
General disorders Fatigue	39.6% 1176/2970 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	35.1% 524/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	35.4% 526/1484 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
General disorders Headache	41.8% 1240/2970 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	38.8% 579/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	37.0% 549/1484 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
General disorders Malaise	28.1% 834/2970 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	24.3% 362/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	23.4% 347/1484 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.
General disorders Temperature (Orally)	12.1% 360/2970 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	10.6% 158/1491 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	11.3% 167/1484 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.	— 0/0 • Serious Adverse Events: -Group GD2-AS04, Group Havrix and Group Saline: during the active study period (Month 0 - 12). -GD2-AS04 (ESFU) Group and Pooled Group: during the combined active study period and the ESFU period (Month 0 - 18). Other Adverse Events: -Solicited local/general symptoms: during the 7-day post-vaccination period. -Unsolicited Adverse Events: during the 30-day post-vaccination. The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. Other Adverse Events were not collected during the ESFU period, hence resulting in zero participants at risk for GD2-AS04 (ESFU) Group and Pooled Group.

Additional Information

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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