Trial Outcomes & Findings for Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years (NCT NCT04869982)

NCT ID: NCT04869982

Last Updated: 2025-01-20

Results Overview

A suspected case of HZ was defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A confirmed case of HZ was diagnosed by Polymerase Chain Reaction (PCR) or by the HZ Ascertainment Committee (HZAC) determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 6138 participants
• Primary outcome timeframe: From Month 3 (30 days after the second vaccination) up to study end (duration of approximately 2 years)
• Results posted on: 2025-01-20

Participant Flow

The study was conducted at 6 centers in China.

A total of 6138 participants were enrolled into the study, of which 6128 participants received at least 1 dose of study treatment/vaccine (RZV or placebo) and were included in the Exposed Set.

Participant milestones

Measure	RZV Group Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Overall Study STARTED	3064	3064
Overall Study COMPLETED	3040	3048
Overall Study NOT COMPLETED	24	16

Reasons for withdrawal

Measure	RZV Group Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Overall Study Consent withdrawal, not due to a (S)AE	7	2
Overall Study Migrated / moved from the study area	1	1
Overall Study Adverse event requiring expedited reporting	13	11
Overall Study Unsolicited non-serious adverse event	1	1
Overall Study Solicited adverse event	2	1

Baseline Characteristics

Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years

Baseline characteristics by cohort

Measure	RZV Group n=3064 Participants Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=3064 Participants Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.	Total n=6128 Participants Total of all reporting groups
Age, Continuous	62.4 Years STANDARD_DEVIATION 7.8 • n=5 Participants	62.4 Years STANDARD_DEVIATION 7.8 • n=7 Participants	62.4 Years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	1868 Participants n=5 Participants	1872 Participants n=7 Participants	3740 Participants n=5 Participants
Sex: Female, Male Male	1196 Participants n=5 Participants	1192 Participants n=7 Participants	2388 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	3064 Participants n=5 Participants	3064 Participants n=7 Participants	6128 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Month 3 (30 days after the second vaccination) up to study end (duration of approximately 2 years)

Population: The analysis was performed on the modified Exposed Set, which excluded participants from the Exposed Set who were not administered 2 doses of the study vaccine, or who developed a confirmed case of HZ prior to 30 days after the second vaccination.

A suspected case of HZ was defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A confirmed case of HZ was diagnosed by Polymerase Chain Reaction (PCR) or by the HZ Ascertainment Committee (HZAC) determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.

Outcome measures

Measure	RZV Group n=2965 Participants Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=2991 Participants Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Incidence Rate of Confirmed Herpes Zoster (HZ) Cases	0.0 Cases per 1000 person-years	8.2 Cases per 1000 person-years

SECONDARY outcome

Timeframe: From Month 3 (30 days after the second vaccination) up to study end (duration of approximately 2 years)

Population: The analysis was performed on the modified Exposed Set, which excluded participants from the Exposed Set who were not administered 2 doses of the study vaccine, or who developed a confirmed case of HZ prior to 30 days after the second vaccination.

A suspected case of HZ was defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A confirmed case of HZ was diagnosed by PCR or by the HZAC determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000. The age categories assessed were 50-69 and greater than or equal to (>=) 70 years of age (YOA).

Outcome measures

Measure	RZV Group n=2965 Participants Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=2991 Participants Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Incidence Rate of Confirmed HZ Cases, by Age Category 50-69 YOA	0.0 Cases per 1000 person-years	7.4 Cases per 1000 person-years
Incidence Rate of Confirmed HZ Cases, by Age Category >=70 YOA	0.0 Cases per 1000 person-years	11.4 Cases per 1000 person-years

SECONDARY outcome

Timeframe: Within 7 days after each vaccination (occurring at Day 1 and Month 2)

Population: The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment and who have documented solicited AEs after each vaccination (i.e. diary card for solicited AEs completed and returned).

Assessed solicited local AEs included erythema, pain and swelling at injection site. The intensity of a solicited local AE was scored at GSK by using GSK's standard grading scale as follows: Any AE = occurrence of the event regardless of intensity grade. At least Grade 3 AE = occurrence of an at least Grade 3 or Grade 4 event (Grade 4 defined for some solicited AEs collected in the study as required by Chinese grading scale). Maximum of Grade 3 and 4 was considered as Grade 3 for all applicable solicited symptoms in GSK standard grading table. AE resulting in a medically attended visit = event for which the participant received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.

Outcome measures

Measure	RZV Group n=3053 Participants Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=3058 Participants Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit Any Erythema, post-vaccination at Day 1	600 Participants	14 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit At least Grade 3 Erythema, post-vaccination at Day 1	25 Participants	0 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit Medically attended visit Erythema, post-vaccination at Day 1	8 Participants	0 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit Any Pain, post-vaccination at Day 1	2045 Participants	217 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit At least Grade 3 Pain, post-vaccination at Day 1	78 Participants	3 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit Medically attended visit Pain, post-vaccination at Day 1	18 Participants	0 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit Any Swelling, post-vaccination at Day 1	705 Participants	18 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit At least Grade 3 Swelling, post-vaccination at Day 1	19 Participants	0 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit Medically attended visit Swelling, post-vaccination at Day 1	11 Participants	0 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit Any Erythema, post-vaccination at Month 2	375 Participants	9 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit At least Grade 3 Erythema, post-vaccination at Month 2	7 Participants	0 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit Medically attended visit Erythema, post-vaccination at Month 2	4 Participants	0 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit Any Pain, post-vaccination at Month 2	1255 Participants	99 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit At least Grade 3 Pain, post-vaccination at Month 2	31 Participants	0 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit Medically attended visit Pain, post-vaccination at Month 2	10 Participants	1 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit Any Swelling, post-vaccination at Month 2	388 Participants	8 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit At least Grade 3 Swelling, post-vaccination at Month 2	5 Participants	0 Participants
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit Medically attended visit Swelling, post-vaccination at Month 2	5 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 7 days after each vaccination (occurring at Day 1 and Month 2)

Population: The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment and who have documented solicited AEs after each vaccination (i.e. diary card for solicited AEs completed and returned).

Assessed solicited general AEs included fatigue, fever, gastrointestinal symptoms (nausea, vomiting and/or abdominal pain) headache, myalgia, and shivering. The intensity of a solicited general AE was scored at GSK by using GSK's standard grading scale as follows: Any AE = occurrence of the event regardless of intensity grade or relation to vaccination. At least Grade 3 AE = occurrence of an at least Grade 3 or Grade 4 event (Grade 4 defined for some solicited AEs collected in the study as required by Chinese grading scale). Maximum of Grade 3 and 4 was considered as Grade 3 for all applicable solicited symptoms in GSK standard grading table. Related AE = event assessed by the investigator as related to vaccination. AE resulting in a medically attended visit = event for which the participant received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.

Outcome measures

Measure	RZV Group n=3053 Participants Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=3058 Participants Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Any Fatigue, post-vaccination at Day 1	1070 Participants	131 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit At least Grade 3 Fatigue, post-vaccination at Day 1	56 Participants	3 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Related Fatigue, post-vaccination at Day 1	1058 Participants	127 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Medically attended visit Fatigue, post-vaccination at Day 1	20 Participants	2 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Any Fever, post-vaccination at Day 1	260 Participants	14 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit At least Grade 3 Fever, post-vaccination at Day 1	12 Participants	0 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Related Fever, post-vaccination at Day 1	259 Participants	14 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Medically attended visit Fever, post-vaccination at Day 1	10 Participants	3 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Any Gastrointestinal symptoms, post-vaccination at Day 1	331 Participants	51 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit At least Grade 3 Gastrointestinal symptoms, post-vaccination at Day 1	11 Participants	1 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Related Gastrointestinal symptoms, post-vaccination at Day 1	322 Participants	44 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Medically attended visit Gastrointestinal symptoms, post-vaccination at Day 1	8 Participants	5 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Any Headache, post-vaccination at Day 1	746 Participants	74 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit At least Grade 3 Headache, post-vaccination at Day 1	37 Participants	1 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Related Headache, post-vaccination at Day 1	738 Participants	69 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Medically attended visit Headache, post-vaccination at Day 1	16 Participants	2 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Any Myalgia, post-vaccination at Day 1	602 Participants	55 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit At least Grade 3 Myalgia, post-vaccination at Day 1	32 Participants	2 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Related Myalgia, post-vaccination at Day 1	593 Participants	55 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Medically attended visit Myalgia, post-vaccination at Day 1	6 Participants	1 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Any Shivering, post-vaccination at Day 1	351 Participants	12 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit At least Grade 3 Shivering, post-vaccination at Day 1	6 Participants	0 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Related Shivering, post-vaccination at Day 1	347 Participants	12 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Medically attended visit Shivering, post-vaccination at Day 1	7 Participants	1 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Any Fatigue, post-vaccination at Month 2	797 Participants	44 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit At least Grade 3 Fatigue, post-vaccination at Month 2	32 Participants	0 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Related Fatigue, post-vaccination at Month 2	793 Participants	44 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Medically attended visit Fatigue, post-vaccination at Month 2	10 Participants	0 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Any Fever, post-vaccination at Month 2	284 Participants	6 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit At least Grade 3 Fever, post-vaccination at Month 2	14 Participants	0 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Related Fever, post-vaccination at Month 2	283 Participants	6 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Medically attended visit Fever, post-vaccination at Month 2	7 Participants	1 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Any Gastrointestinal symptoms, post-vaccination at Month 2	190 Participants	20 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit At least Grade 3 Gastrointestinal symptoms, post-vaccination at Month 2	1 Participants	1 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Related Gastrointestinal symptoms, post-vaccination at Month 2	186 Participants	19 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Medically attended visit Gastrointestinal symptoms, post-vaccination at Month 2	7 Participants	2 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Any Headache, post-vaccination at Month 2	575 Participants	26 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit At least Grade 3 Headache, post-vaccination at Month 2	20 Participants	0 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Related Headache, post-vaccination at Month 2	573 Participants	26 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Medically attended visit Headache, post-vaccination at Month 2	10 Participants	2 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Any Myalgia, post-vaccination at Month 2	464 Participants	21 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit At least Grade 3 Myalgia, post-vaccination at Month 2	20 Participants	0 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Related Myalgia, post-vaccination at Month 2	464 Participants	21 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Medically attended visit Myalgia, post-vaccination at Month 2	8 Participants	0 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Any Shivering, post-vaccination at Month 2	334 Participants	4 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit At least Grade 3 Shivering, post-vaccination at Month 2	12 Participants	0 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Related Shivering, post-vaccination at Month 2	333 Participants	4 Participants
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit Medically attended visit Shivering, post-vaccination at Month 2	5 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 30 days after any vaccination (occurring at Day 1 and Month 2)

Population: The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment.

An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study, or any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms. At least one unsolicited AE = at least one event regardless of intensity grade or relation to study vaccination. At least one Grade 3 unsolicited AE = at least one event that prevented normal, everyday activities. At least one related unsolicited AE = at least one event assessed by the investigator as related to the study vaccination. At least one Grade 3 related unsolicited AE = at least one event that prevented normal, everyday activities assessed by the investigator as related to the study vaccination. At least one medically attended unsolicited AE = at least one event for which the participant received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.

Outcome measures

Measure	RZV Group n=3064 Participants Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=3064 Participants Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Number of Participants With at Least One Unsolicited AE, at Least One Grade 3 Unsolicited AE, at Least One Related Unsolicited AE, at Least One Grade 3 Related Unsolicited AE and With at Least One Medically Attended Unsolicited AE At least one unsolicited AE	124 Participants	97 Participants
Number of Participants With at Least One Unsolicited AE, at Least One Grade 3 Unsolicited AE, at Least One Related Unsolicited AE, at Least One Grade 3 Related Unsolicited AE and With at Least One Medically Attended Unsolicited AE At least one Grade 3 unsolicited AE	8 Participants	10 Participants
Number of Participants With at Least One Unsolicited AE, at Least One Grade 3 Unsolicited AE, at Least One Related Unsolicited AE, at Least One Grade 3 Related Unsolicited AE and With at Least One Medically Attended Unsolicited AE At least one related unsolicited AE	31 Participants	17 Participants
Number of Participants With at Least One Unsolicited AE, at Least One Grade 3 Unsolicited AE, at Least One Related Unsolicited AE, at Least One Grade 3 Related Unsolicited AE and With at Least One Medically Attended Unsolicited AE At least one Grade 3 related unsolicited AE	0 Participants	1 Participants
Number of Participants With at Least One Unsolicited AE, at Least One Grade 3 Unsolicited AE, at Least One Related Unsolicited AE, at Least One Grade 3 Related Unsolicited AE and With at Least One Medically Attended Unsolicited AE At least one medically attended unsolicited AE(s)	64 Participants	53 Participants

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to 30 days post last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)

Population: The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment.

An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one SAE = at least one SAE regardless of relation to study vaccination. At least one related SAE = at least one SAE assessed by the investigator as related to the study vaccination.

Outcome measures

Measure	RZV Group n=3064 Participants Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=3064 Participants Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Number of Participants With at Least One Serious Adverse Event (SAE) and With at Least One Related SAE From First Vaccination (Day 1) up to 30 Days Post Last Vaccination At least one SAE	32 Participants	36 Participants
Number of Participants With at Least One Serious Adverse Event (SAE) and With at Least One Related SAE From First Vaccination (Day 1) up to 30 Days Post Last Vaccination At least one related SAE	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to 12 months post last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)

Population: The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment.

An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one SAE = at least one SAE regardless of relation to study vaccination. At least one related SAE = at least one SAE assessed by the investigator as related to the study vaccination.

Outcome measures

Measure	RZV Group n=3064 Participants Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=3064 Participants Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Number of Participants With at Least One SAE and With at Least One Related SAE From First Vaccination (Day 1) up to 12 Months Post Last Vaccination At least one SAE	88 Participants	93 Participants
Number of Participants With at Least One SAE and With at Least One Related SAE From First Vaccination (Day 1) up to 12 Months Post Last Vaccination At least one related SAE	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to study end (duration of approximately 2 years)

Population: The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment.

An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one related SAE = at least one SAE assessed by the investigator as related to the study vaccination.

Outcome measures

Measure	RZV Group n=3064 Participants Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=3064 Participants Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Number of Participants With at Least One Related SAE From First Vaccination (Day 1) up to Study End (Duration of Approximately 2 Years)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From the time the participant consented to participate in the study (Day 1) up to study end (duration of approximately 2 years)

Population: The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment.

An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or was considered medically significant. SAEs related to study participation (and not to the study vaccine) or to GSK concomitant medication/vaccine were assessed.

Outcome measures

Measure	RZV Group n=3064 Participants Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=3064 Participants Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Number of Participants With at Least One SAE Related to Study Participation or to GlaxoSmithKline Concomitant Medication/Vaccine	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to 30 days post last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)

Population: The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment.

An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one fatal SAE = at least one fatal SAE regardless of relation to study vaccination. At least one related fatal SAE = at least one fatal SAE assessed by the investigator as related to the study vaccination.

Outcome measures

Measure	RZV Group n=3064 Participants Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=3064 Participants Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Number of Participants With at Least One Fatal SAE and at Least One Related Fatal SAE From First Vaccination (Day 1) up to 30 Days Post Last Vaccination At least one fatal SAE	3 Participants	2 Participants
Number of Participants With at Least One Fatal SAE and at Least One Related Fatal SAE From First Vaccination (Day 1) up to 30 Days Post Last Vaccination At least one related fatal SAE	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to 12 months post last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)

Population: The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment.

An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one fatal SAE = at least one fatal SAE regardless of relation to study vaccination. At least one related fatal SAE = at least one fatal SAE assessed by the investigator as related to the study vaccination.

Outcome measures

Measure	RZV Group n=3064 Participants Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=3064 Participants Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Number of Participants With at Least One Fatal SAE and With at Least One Related Fatal SAE From First Vaccination (Day 1) up to 12 Months Post Last Vaccination At least one fatal SAE	11 Participants	9 Participants
Number of Participants With at Least One Fatal SAE and With at Least One Related Fatal SAE From First Vaccination (Day 1) up to 12 Months Post Last Vaccination At least one related fatal SAE	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to study end (duration of approximately 2 years)

Population: The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment.

An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, or resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one related fatal SAE = at least one fatal SAE assessed by the investigator as related to the study vaccination.

Outcome measures

Measure	RZV Group n=3064 Participants Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=3064 Participants Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Number of Participants With at Least One Related Fatal SAE From First Vaccination (Day 1) up to Study End (Duration of Approximately 2 Years)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to 30 days post last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)

Population: The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment.

pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. At least one pIMD = at least one pIMD regardless of relation to vaccination. At least one related pIMD = at least one pIMD assessed by the investigator as related to the study vaccination.

Outcome measures

Measure	RZV Group n=3064 Participants Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=3064 Participants Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Number of Participants With at Least One Potential Immune-mediated Disease (pIMD) and at Least One Related pIMD From First Vaccination (Day 1) up to 30 Days Post Last Vaccination At least one pIMD	2 Participants	2 Participants
Number of Participants With at Least One Potential Immune-mediated Disease (pIMD) and at Least One Related pIMD From First Vaccination (Day 1) up to 30 Days Post Last Vaccination At least one related pIMD	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to 12 months post last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)

Population: The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment.

pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. At least one pIMD = at least one pIMD regardless of relation to study vaccination. At least one related pIMD = at least one related pIMD assessed by the investigator as related to the study vaccination.

Outcome measures

Measure	RZV Group n=3064 Participants Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=3064 Participants Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Number of Participants With at Least One pIMD and at Least One Related pIMD From First Vaccination (Day 1) up to 12 Months Post Last Vaccination At least one pIMD	2 Participants	3 Participants
Number of Participants With at Least One pIMD and at Least One Related pIMD From First Vaccination (Day 1) up to 12 Months Post Last Vaccination At least one related pIMD	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From 12 months post last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses) up to study end (duration of approximately 1 year)

Population: The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment.

pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. At least one related serious pIMD = at least one serious pIMD assessed by the investigator as related to the study vaccination.

Outcome measures

Measure	RZV Group n=3064 Participants Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=3064 Participants Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Number of Participants With at Least One Related Serious pIMD From 12 Months Post Last Vaccination up to Study End (Duration of Approximately 1 Year)	0 Participants	0 Participants

Adverse Events

RZV Group

Serious events: 90 serious events

Other events: 2337 other events

Deaths: 13 deaths

Placebo Group

Serious events: 94 serious events

Other events: 485 other events

Deaths: 11 deaths

Serious adverse events

Measure	RZV Group n=3064 participants at risk Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=3064 participants at risk Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Blood and lymphatic system disorders Agranulocytosis	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Acute myocardial infarction	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Angina pectoris	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Angina unstable	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Arrhythmia	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Arteriosclerosis coronary artery	0.26% 8/3064 • Number of events 9 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.13% 4/3064 • Number of events 4 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Atrial fibrillation	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Cardiac disorder	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Cardiac dysfunction	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Cardiac failure	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Cardiac failure acute	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Cardiac failure chronic	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Coronary artery disease	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Coronary artery insufficiency	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Defect conduction intraventricular	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Left ventricular failure	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Myocardial infarction	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Palpitations	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Sinus node dysfunction	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Ventricular extrasystoles	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Congenital, familial and genetic disorders Oesophageal cyst	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Ear and labyrinth disorders Vertigo	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Endocrine disorders Thyroid mass	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Endocrine disorders Thyroiditis subacute	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Eye disorders Cataract	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Eye disorders Diabetic blindness	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Eye disorders Glaucoma	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Eye disorders Pterygium	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Eye disorders Refraction disorder	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Eye disorders Vitreous haemorrhage	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Abdominal hernia	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Abdominal mass	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Chronic gastritis	0.13% 4/3064 • Number of events 4 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Constipation	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Duodenal ulcer	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Gastric polyps	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Haemoperitoneum	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Haemorrhagic erosive gastritis	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Inguinal hernia	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Large intestine polyp	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Peritoneal perforation	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Multiple organ dysfunction syndrome	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Sudden death	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Hepatobiliary disorders Cholecystitis acute	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Hepatobiliary disorders Cholelithiasis	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Immune system disorders Haemophagocytic lymphohistiocytosis	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Appendicitis	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Bronchitis	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Cholecystitis infective	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Erysipelas	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Gastroenteritis	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Infection	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Pneumonia	0.16% 5/3064 • Number of events 5 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.20% 6/3064 • Number of events 6 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Respiratory tract infection	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Skin infection	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Brain contusion	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Brain herniation	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Contusion	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Craniocerebral injury	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Electrical burn	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Epidural haemorrhage	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Facial bones fracture	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Foot fracture	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Humerus fracture	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Jaw fracture	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Joint injury	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Limb crushing injury	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Limb fracture	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Meniscus injury	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Pleural injury	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Radius fracture	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Rib fracture	0.13% 4/3064 • Number of events 4 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Scapula fracture	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Skull fracture	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Spinal cord injury cervical	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Subdural haemorrhage	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Tibia fracture	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Ulna fracture	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Metabolism and nutrition disorders Diabetic complication	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Arthritis	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.13% 4/3064 • Number of events 4 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage III	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to pleura	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Basal ganglia haemorrhage	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Cerebral haemorrhage	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Cerebral infarction	0.78% 24/3064 • Number of events 24 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.59% 18/3064 • Number of events 18 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Cerebral thrombosis	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Diabetic neuropathy	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Facial paralysis	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Haemorrhage intracranial	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Hemiplegia	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Intraventricular haemorrhage	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Lacunar infarction	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Quadriplegia	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Subarachnoid haemorrhage	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Psychiatric disorders Completed suicide	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Psychiatric disorders Conversion disorder	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Renal and urinary disorders Acute kidney injury	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Renal and urinary disorders Diabetic nephropathy	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Renal and urinary disorders Hydronephrosis	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Renal and urinary disorders Renal cyst	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Renal and urinary disorders Ureterolithiasis	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Renal and urinary disorders Urethral prolapse	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Renal and urinary disorders Urinary retention	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Reproductive system and breast disorders Uterovaginal prolapse	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Respiratory, thoracic and mediastinal disorders Emphysema	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Respiratory, thoracic and mediastinal disorders Pharyngeal cyst	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Vascular disorders Diabetic vascular disorder	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Vascular disorders Essential hypertension	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Vascular disorders Hypertension	0.26% 8/3064 • Number of events 9 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.13% 4/3064 • Number of events 4 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Vascular disorders Scalp haematoma	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Vascular disorders Varicose vein	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.

Other adverse events

Measure	RZV Group n=3064 participants at risk Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.	Placebo Group n=3064 participants at risk Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Blood and lymphatic system disorders Lymphadenitis	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Blood and lymphatic system disorders Lymphadenopathy	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Cardiac disorders Tachycardia	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Congenital, familial and genetic disorders Porencephaly	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Ear and labyrinth disorders Deafness bilateral	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Endocrine disorders Thyroiditis subacute	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Abdominal distension	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Abdominal pain	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Abdominal pain upper	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Chronic gastritis	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Diarrhoea	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Dry mouth	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Gastric ulcer	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Gastritis	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Gastrointestinal disorder (	14.5% 444/3064 • Number of events 521 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	2.2% 67/3064 • Number of events 71 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Gingival pain	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Gingival swelling	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Peptic ulcer	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Stomatitis	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Gastrointestinal disorders Toothache	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.13% 4/3064 • Number of events 4 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Administration site erythema	24.9% 762/3064 • Number of events 975 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.69% 21/3064 • Number of events 23 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Administration site pain	71.9% 2203/3064 • Number of events 3300 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	9.1% 280/3064 • Number of events 316 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Administration site swelling	27.9% 855/3064 • Number of events 1093 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.78% 24/3064 • Number of events 26 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Axillary pain	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Chest discomfort	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Chills	17.8% 544/3064 • Number of events 686 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.46% 14/3064 • Number of events 16 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Fatigue	43.3% 1326/3064 • Number of events 1867 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	5.3% 161/3064 • Number of events 175 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Injection site haematoma	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Injection site pain	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Oedema peripheral	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Pain	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Peripheral swelling	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Pyrexia	14.9% 457/3064 • Number of events 544 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.69% 21/3064 • Number of events 21 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Thirst	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Vaccination site induration	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Vaccination site pain	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
General disorders Vaccination site pruritus	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Bronchitis	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Conjunctivitis	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Cystitis	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Folliculitis	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Herpes simplex	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Nasopharyngitis	0.29% 9/3064 • Number of events 9 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.23% 7/3064 • Number of events 7 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Pharyngitis	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Pneumonia	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Tonsillitis	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Upper respiratory tract infection	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Infections and infestations Urinary tract infection	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Animal bite	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Fall	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Injury	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Ligament sprain	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Limb injury	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Injury, poisoning and procedural complications Upper limb fracture	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Investigations Blood uric acid increased	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Metabolism and nutrition disorders Gout	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Metabolism and nutrition disorders Hyperlipidaemia	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Metabolism and nutrition disorders Hypokalaemia	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Arthritis	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Back pain	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Bone pain	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Muscular weakness	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Myalgia	26.5% 811/3064 • Number of events 1067 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	2.3% 71/3064 • Number of events 76 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Pain in extremity	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intracranial haemangioma	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Cerebral infarction	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Cerebrovascular insufficiency	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Dizziness	0.82% 25/3064 • Number of events 27 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.29% 9/3064 • Number of events 9 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Headache	32.7% 1001/3064 • Number of events 1321 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	3.1% 94/3064 • Number of events 102 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Paralysis	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Post herpetic neuralgia	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Nervous system disorders Tension headache	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Psychiatric disorders Insomnia	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Renal and urinary disorders Chronic kidney disease	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Renal and urinary disorders Nephrolithiasis	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Reproductive system and breast disorders Breast pain	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Respiratory, thoracic and mediastinal disorders Cough	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.16% 5/3064 • Number of events 6 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Skin and subcutaneous tissue disorders Blister	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Skin and subcutaneous tissue disorders Dermatitis	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Skin and subcutaneous tissue disorders Dermatitis contact	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Skin and subcutaneous tissue disorders Papule	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.13% 4/3064 • Number of events 4 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Skin and subcutaneous tissue disorders Rash	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Skin and subcutaneous tissue disorders Rash erythematous	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.07% 2/3064 • Number of events 2 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Vascular disorders Essential hypertension	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Vascular disorders Hypertension	0.10% 3/3064 • Number of events 3 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
Vascular disorders Vascular rupture	0.03% 1/3064 • Number of events 1 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.	0.00% 0/3064 • Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years). The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

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