Trial Outcomes & Findings for Study to Assess the Immunogenicity and Safety of GSK's Investigational Vaccine (GSK3277511A) When Given to Healthy Smokers and Ex-smokers After Administration of Shingrix Vaccine (NCT NCT03894969)

Last Updated: 2024-09-23

Results Overview

Antibody concentrations as measured by ELISA (Enzyme-linked immunosorbent assay) and expressed as adjusted (ANCOVA model) GMCs in ELISA units per milliliter (EU/mL). Cut-off value for the assay is 153, 16, 8 and 28 EU/mL for Anti-PD, Anti-PE, Anti-PilA and Anti-UspA2 antibodies respectively. The ANCOVA model includes study group, smoking status (current or former), age category (50-59, 60-69, 70-80 years of age) and center as factors and the antibody concentration before Dose 1 as covariate. As per protocol set (PPS) sample size was not met in Sh\_NTHi\_Mcat\_3 and Sh\_NTHi-Mcat\_6 groups then timeframe was adapted as follows: At 1 month after dose 2 of NTHi-Mcat vaccine (Day 181 in Sh\_NTHi-Mcat\_1 group and Day 91 in NTHi-Mcat group)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

541 participants

Primary outcome timeframe

At 1 month after dose 2 of NTHi-Mcat vaccine (Day 181, in Sh_NTHi-Mcat_1 group and Day 91 in NTHi-Mcat group)

Results posted on

2024-09-23

Participant Flow

542 participants were enrolled in the study, but only 541 received at least 1 dose of study treatment (i.e. Shingrix and/or NTHi Mcat vaccine).

Participant milestones

Participant milestones
Measure	Sh_NTHi-Mcat_1 Group Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	Sh_NTHi-Mcat_3 Group Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 3-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 151 and Day 211.	Sh_NTHi-Mcat_6 Group Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Overall Study STARTED	134	134	122	135	16
Overall Study COMPLETED	129	129	118	128	2
Overall Study NOT COMPLETED	5	5	4	7	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Sh_NTHi-Mcat_1 Group Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	Sh_NTHi-Mcat_3 Group Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 3-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 151 and Day 211.	Sh_NTHi-Mcat_6 Group Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Overall Study Adverse Event	0	2	0	1	2
Overall Study Lost to Follow-up	3	1	1	0	0
Overall Study Withdrawal by Subject	2	1	3	4	8
Overall Study Other	0	0	0	0	3
Overall Study Unsolicited Non-Serious Advers Event	0	0	0	2	1
Overall Study Solicited Adverse Event	0	1	0	0	0

Baseline Characteristics

Study to Assess the Immunogenicity and Safety of GSK's Investigational Vaccine (GSK3277511A) When Given to Healthy Smokers and Ex-smokers After Administration of Shingrix Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sh_NTHi-Mcat_1 Group n=134 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	Sh_NTHi-Mcat_3 Group n=134 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 3-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 151 and Day 211.	Sh_NTHi-Mcat_6 Group n=122 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group n=135 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group n=16 Participants Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.	Total n=541 Participants Total of all reporting groups
Age, Continuous	60.7 Years STANDARD_DEVIATION 7.0 • n=5 Participants	60.9 Years STANDARD_DEVIATION 6.7 • n=7 Participants	60.5 Years STANDARD_DEVIATION 7.1 • n=5 Participants	60.0 Years STANDARD_DEVIATION 7.1 • n=4 Participants	62.4 Years STANDARD_DEVIATION 5.5 • n=21 Participants	60.6 Years STANDARD_DEVIATION 6.9 • n=8 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	66 Participants n=7 Participants	58 Participants n=5 Participants	65 Participants n=4 Participants	7 Participants n=21 Participants	259 Participants n=8 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	68 Participants n=7 Participants	64 Participants n=5 Participants	70 Participants n=4 Participants	9 Participants n=21 Participants	282 Participants n=8 Participants
Race/Ethnicity, Customized American Indian Or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized Black Or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	17 Participants n=8 Participants
Race/Ethnicity, Customized White	129 Participants n=5 Participants	130 Participants n=7 Participants	120 Participants n=5 Participants	129 Participants n=4 Participants	11 Participants n=21 Participants	519 Participants n=8 Participants

PRIMARY outcome

Timeframe: At 1 month after dose 2 of NTHi-Mcat vaccine (Day 181, in Sh_NTHi-Mcat_1 group and Day 91 in NTHi-Mcat group)

Population: Analysis was performed on the per protocol set (PPS) which included all subjects who received full study treatment course to which they were randomized and had post-vaccination immunogenicity data minus subjects with protocol deviations that lead to exclusion.According to protocol,as PPS sample size for Sh\_NTHI\_Mcat\_3 and Sh\_NTHI\_Mcat\_6 Groups was not met,those were not part of the analysis. Shingrix-Only Group was not included in this analysis,as subjects didn't receive the NTHi MCAT vaccine.

Outcome measures

Outcome measures
Measure	Sh_NTHi-Mcat_1 Group n=118 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	NTHi-Mcat Group n=124 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Sh_NTHi-Mcat_6 Group Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Anti-Protein D (PD), Anti-Protein E (PE), Anti-type IV Pili Subunit (PilA) and Anti-ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Adjusted Geometric Mean Concentrations (GMCs), One-month Post Dose-2 of NTHi-Mcat Vaccine Anti-PD	1402.804 EU/mL Interval 1139.194 to 1727.414	1489.531 EU/mL Interval 1203.846 to 1843.014	—	—	—
Anti-Protein D (PD), Anti-Protein E (PE), Anti-type IV Pili Subunit (PilA) and Anti-ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Adjusted Geometric Mean Concentrations (GMCs), One-month Post Dose-2 of NTHi-Mcat Vaccine Anti-PE	6234.827 EU/mL Interval 5053.049 to 7692.992	7032.52 EU/mL Interval 5666.105 to 8728.452	—	—	—
Anti-Protein D (PD), Anti-Protein E (PE), Anti-type IV Pili Subunit (PilA) and Anti-ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Adjusted Geometric Mean Concentrations (GMCs), One-month Post Dose-2 of NTHi-Mcat Vaccine Anti-PilA	1244.373 EU/mL Interval 963.063 to 1607.854	1089.799 EU/mL Interval 840.246 to 1413.47	—	—	—
Anti-Protein D (PD), Anti-Protein E (PE), Anti-type IV Pili Subunit (PilA) and Anti-ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Adjusted Geometric Mean Concentrations (GMCs), One-month Post Dose-2 of NTHi-Mcat Vaccine Anti-UspA2	1022.961 EU/mL Interval 894.403 to 1169.998	941.45 EU/mL Interval 820.993 to 1079.58	—	—	—

SECONDARY outcome

Timeframe: Before the first dose of NTHi-Mcat vaccine (Day 91, Day 151 and Day 241 for Sh_NTHi-Mcat_1, Sh_NTHi-Mcat_3 and Sh_NTHi-Mcat_6 group, respectively, and Day 1 for NTHi-Mcat group)

Population: Analysis was performed on the PPS which included all subjects who received full study treatment course to which they were randomized and had post-vaccination immunogenicity data minus subjects with protocol deviations that lead to exclusion. Subjects from the Shingrix-Only Group were not included in this analysis, as they didn't receive the NTHi MCAT vaccine.

GMCs and their 95% CI for each of the antibodies, as measured by ELISA, were calculated (the GMCs were computed by taking the Anti-log of the mean of the log concentration transformations)

Outcome measures

Outcome measures
Measure	Sh_NTHi-Mcat_1 Group n=118 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	NTHi-Mcat Group n=96 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Sh_NTHi-Mcat_6 Group n=73 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group n=124 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibody Concentrations in Terms of GMCs, Before First NTHi-Mcat Vaccine Anti-PD	94.7 EU/mL Interval 86.2 to 104.1	105.1 EU/mL Interval 89.8 to 123.0	95.6 EU/mL Interval 84.5 to 108.3	105.3 EU/mL Interval 93.4 to 118.6	—
Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibody Concentrations in Terms of GMCs, Before First NTHi-Mcat Vaccine Anti-PE	22 EU/mL Interval 18.0 to 26.9	21.2 EU/mL Interval 17.6 to 25.4	18.6 EU/mL Interval 14.3 to 24.2	23.9 EU/mL Interval 19.8 to 28.9	—
Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibody Concentrations in Terms of GMCs, Before First NTHi-Mcat Vaccine Anti-PilA	7.8 EU/mL Interval 6.6 to 9.3	10.5 EU/mL Interval 8.2 to 13.5	9.7 EU/mL Interval 7.5 to 12.6	9.1 EU/mL Interval 7.5 to 11.0	—
Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibody Concentrations in Terms of GMCs, Before First NTHi-Mcat Vaccine Anti-UspA2	352.4 EU/mL Interval 292.5 to 424.7	343 EU/mL Interval 286.3 to 411.0	440.3 EU/mL Interval 343.5 to 564.5	521.4 EU/mL Interval 441.0 to 616.3	—

SECONDARY outcome

Timeframe: At one month after the second dose of NTHi-Mcat vaccine (Day 181, 241, 331 in the Sh_NTHi-Mcat_1, Sh_NTHi-Mcat_3 and Sh_NTHi-Mcat_6 group, respectively, and Day 91 in the NTHi-Mcat group)

GMCs and their 95% CI for each of the antibodies, as measured by ELISA, were calculated (the GMCs were computed by taking the Anti-log of the mean of the log concentration transformations) before the first dose of NTHi-Mcat vaccine

Outcome measures

Outcome measures
Measure	Sh_NTHi-Mcat_1 Group n=118 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	NTHi-Mcat Group n=96 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Sh_NTHi-Mcat_6 Group n=73 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group n=124 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibody Concentrations in Terms of GMCs, One-month Post Dose-2 of NTHi-Mcat Vaccine Anti-PD	1496.7 EU/mL Interval 1272.7 to 1760.1	1504 EU/mL Interval 1209.9 to 1869.6	1539 EU/mL Interval 1277.3 to 1854.2	1683.5 EU/mL Interval 1434.5 to 1975.5	—
Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibody Concentrations in Terms of GMCs, One-month Post Dose-2 of NTHi-Mcat Vaccine Anti-PE	5911.8 EU/mL Interval 5121.3 to 6824.3	5920.8 EU/mL Interval 4868.4 to 7200.8	6048.5 EU/mL Interval 4943.3 to 7400.8	6562.4 EU/mL Interval 5660.9 to 7607.5	—
Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibody Concentrations in Terms of GMCs, One-month Post Dose-2 of NTHi-Mcat Vaccine Anti-PilA	1089.3 EU/mL Interval 910.3 to 1303.4	1030.6 EU/mL Interval 839.4 to 1265.3	1114.7 EU/mL Interval 864.9 to 1436.6	999.3 EU/mL Interval 830.3 to 1202.7	—
Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibody Concentrations in Terms of GMCs, One-month Post Dose-2 of NTHi-Mcat Vaccine Anti-UspA2	926.8 EU/mL Interval 796.6 to 1078.4	942.2 EU/mL Interval 819.6 to 1083.2	1289.2 EU/mL Interval 1062.5 to 1564.5	1066.4 EU/mL Interval 946.6 to 1201.4	—

SECONDARY outcome

Timeframe: Before the first dose of NTHi-Mcat vaccine (Day 91, Day 151 and Day 241 in the Sh_NTHi-Mcat_1, Sh_NTHi-Mcat_3 and Sh_NTHi-Mcat_6 group, respectively, and Day 1 in the NTHi-Mcat group)

A seropositive subject is defined as a subject whose Anti-PD, Anti-PE, Anti-PilA and Anti-UspA2 antibody concentrations are greater than or equal to the assay cut-off value. Seropositivity rates with 95% CI is defined using the assay lower limit of quantification (LLOQ). Cut-off value for the assay is 153, 16, 8 and 28 EU/mL for Anti-PD, Anti-PE, Anti-PilA and Anti-UspA2 antibodies respectively

Outcome measures

Outcome measures
Measure	Sh_NTHi-Mcat_1 Group n=118 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	NTHi-Mcat Group n=96 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Sh_NTHi-Mcat_6 Group n=73 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group n=124 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Percentage of Seropositive Subjects for Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibodies Before First NTHi-Mcat Vaccine Anti-PD	16.9 Percentage of subjects Interval 10.7 to 25.0	20 Percentage of subjects Interval 12.5 to 29.5	19.2 Percentage of subjects Interval 10.9 to 30.1	21.8 Percentage of subjects Interval 14.9 to 30.1	—
Percentage of Seropositive Subjects for Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibodies Before First NTHi-Mcat Vaccine Anti-PE	57.6 Percentage of subjects Interval 48.2 to 66.7	63.5 Percentage of subjects Interval 53.1 to 73.1	50.7 Percentage of subjects Interval 38.7 to 62.6	61.8 Percentage of subjects Interval 52.6 to 70.4	—
Percentage of Seropositive Subjects for Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibodies Before First NTHi-Mcat Vaccine Anti-PilA	38.1 Percentage of subjects Interval 29.4 to 47.5	49 Percentage of subjects Interval 38.6 to 59.4	47.9 Percentage of subjects Interval 36.1 to 60.0	43.5 Percentage of subjects Interval 34.7 to 52.7	—
Percentage of Seropositive Subjects for Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibodies Before First NTHi-Mcat Vaccine Anti-UspA2	100 Percentage of subjects Interval 96.9 to 100.0	100 Percentage of subjects Interval 96.2 to 100.0	100 Percentage of subjects Interval 95.1 to 100.0	100 Percentage of subjects Interval 97.1 to 100.0	—

SECONDARY outcome

Timeframe: At one month after the second dose of NTHi-Mcat vaccine (Day 181, 241, 331 in the Sh_NTHi-Mcat_1, Sh_NTHi-Mcat_3 and Sh_NTHi-Mcat_6 group, respectively, and Day 91 in the NTHi-Mcat group)

A seropositive subject is defined as a subject whose Anti-PD, Anti-PE, Anti-PilA and Anti-UspA2 antibody concentrations are greater than or equal to the assay cut-off value. Seropositivity rates with 95% CI are defined using the assay (LLOQ). Cut-off value for the assay is 153, 16, 8 and 28 EU/mL for Anti-PD, Anti-PE, Anti-PilA and Anti-UspA2 antibodies respectively

Outcome measures

Outcome measures
Measure	Sh_NTHi-Mcat_1 Group n=118 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	NTHi-Mcat Group n=96 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Sh_NTHi-Mcat_6 Group n=73 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group n=124 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Percentage of Subjects Seropositive for Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibodies, One-month Post Dose-2 of NTHi-Mcat Vaccine Anti-PD	99.2 Percentage of subjects Interval 95.4 to 100.0	97.9 Percentage of subjects Interval 92.7 to 99.7	100 Percentage of subjects Interval 95.1 to 100.0	100 Percentage of subjects Interval 97.0 to 100.0	—
Percentage of Subjects Seropositive for Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibodies, One-month Post Dose-2 of NTHi-Mcat Vaccine Anti-PE	100 Percentage of subjects Interval 96.9 to 100.0	100 Percentage of subjects Interval 96.2 to 100.0	100 Percentage of subjects Interval 95.1 to 100.0	100 Percentage of subjects Interval 97.1 to 100.0	—
Percentage of Subjects Seropositive for Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibodies, One-month Post Dose-2 of NTHi-Mcat Vaccine Anti-PilA	100 Percentage of subjects Interval 96.9 to 100.0	100 Percentage of subjects Interval 96.2 to 100.0	100 Percentage of subjects Interval 95.1 to 100.0	100 Percentage of subjects Interval 97.1 to 100.0	—
Percentage of Subjects Seropositive for Anti-PD, Anti-PE, Anti-PilA, Anti-UspA2 Antibodies, One-month Post Dose-2 of NTHi-Mcat Vaccine Anti-UspA2	100 Percentage of subjects Interval 96.9 to 100.0	100 Percentage of subjects Interval 96.2 to 100.0	100 Percentage of subjects Interval 95.1 to 100.0	100 Percentage of subjects Interval 97.1 to 100.0	—

SECONDARY outcome

Timeframe: Before the first dose of NTHi-Mcat vaccine (Day 91, Day 151 and Day 241 in the Sh_NTHi-Mcat_1, Sh_NTHi-Mcat_3 and Sh_NTHi-Mcat_6 group, respectively, and Day 1 in the NTHi-Mcat group)

Population: Analysis was performed on Cell-Mediated immune (CMI) sub-cohort, which included approximately 60 subjects (15/each group), for which an additional blood sample was taken at each pre-defined timepoint (sub-cohort selected from sites able to process the blood samples according to GSK procedures for peripheral blood mononuclear cell preparation). Subjects from the Shingrix-Only Group were not included in this analysis, as they didn't receive the NTHi MCAT vaccine.

Frequency of specific CD4+ T-cells was measured by flow cytometry intracellular cytokine staining (ICS) expressing at least 2 different markers among CD40 Ligand (CD40L), interleukin (IL)-2, IL-13, IL-17, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), upon in vitro stimulation

Outcome measures

Outcome measures
Measure	Sh_NTHi-Mcat_1 Group n=10 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	NTHi-Mcat Group n=12 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Sh_NTHi-Mcat_6 Group n=3 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group n=13 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi and Mcat Antigens for Evaluation of Cell-mediated Immune (CMI) Response, Before First Dose of NTHi-Mcat Vaccine NTHi.PE - CD4+ T-cells	79.838 CD4+ T cells/million cells Standard Deviation 58.999	46.112 CD4+ T cells/million cells Standard Deviation 63.007	69.546 CD4+ T cells/million cells Standard Deviation 97.09	80.717 CD4+ T cells/million cells Standard Deviation 119.316	—
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi and Mcat Antigens for Evaluation of Cell-mediated Immune (CMI) Response, Before First Dose of NTHi-Mcat Vaccine M catarrhalis.UspA2 - CD4+ T-cells	112.945 CD4+ T cells/million cells Standard Deviation 153.903	101.739 CD4+ T cells/million cells Standard Deviation 94.932	81.578 CD4+ T cells/million cells Standard Deviation 90.919	92.685 CD4+ T cells/million cells Standard Deviation 99.661	—
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi and Mcat Antigens for Evaluation of Cell-mediated Immune (CMI) Response, Before First Dose of NTHi-Mcat Vaccine NTHi.PD - CD4+ T-cells	89.456 CD4+ T cells/million cells Standard Deviation 68.929	59.522 CD4+ T cells/million cells Standard Deviation 82.06	36.439 CD4+ T cells/million cells Standard Deviation 57.347	96.893 CD4+ T cells/million cells Standard Deviation 74.87	—
Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi and Mcat Antigens for Evaluation of Cell-mediated Immune (CMI) Response, Before First Dose of NTHi-Mcat Vaccine NTHi.PilA - CD4+ T-cells	61.627 CD4+ T cells/million cells Standard Deviation 53.613	42.438 CD4+ T cells/million cells Standard Deviation 55.575	60.139 CD4+ T cells/million cells Standard Deviation 51.37	105.558 CD4+ T cells/million cells Standard Deviation 97.618	—

SECONDARY outcome

Timeframe: At one month after second dose of NTHi-Mcat vaccine (Day 181, Day 241 and Day 331 in the Sh_NTHi-Mcat_1, Sh_NTHi-Mcat_3 and Sh_NTHi-Mcat_6 group, respectively, and Day 91 in the NTHi-Mcat group)

Population: Analysis was performed on CMI sub-cohort, which included approximately 60 subjects (15/each group), for which an additional blood sample was taken at each pre-defined time point (sub-cohort selected from sites able to process the blood samples according to GSK procedures for peripheral blood mononuclear cell preparation). Subjects from the Shingrix-Only Group were not included in this analysis, as they didn't receive the NTHi MCAT vaccine.

Frequency of specific CD4+ T-cells was measured by flow cytometry ICS expressing at least 2 different markers among CD40L, IL-2, IL-13, IL-17, TNF-α and IFN-γ, upon in vitro stimulation

Outcome measures

Outcome measures
Measure	Sh_NTHi-Mcat_1 Group n=10 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	NTHi-Mcat Group n=11 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Sh_NTHi-Mcat_6 Group n=3 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group n=13 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Frequency of CD4+ T-cells Against NTHi and Mcat Antigens for Evaluation of CMI Response, at One-month Post Dose 2 of NTHi-Mcat Vaccine M catarrhalis.UspA2 - CD4+ T-cells	721.851 CD4+ T cells/million cells Standard Deviation 457.94	619.68 CD4+ T cells/million cells Standard Deviation 392.133	1001.839 CD4+ T cells/million cells Standard Deviation 144.057	735.177 CD4+ T cells/million cells Standard Deviation 471.515	—
Frequency of CD4+ T-cells Against NTHi and Mcat Antigens for Evaluation of CMI Response, at One-month Post Dose 2 of NTHi-Mcat Vaccine NTHi.PD - CD4+ T-cells	632.849 CD4+ T cells/million cells Standard Deviation 323.731	527.26 CD4+ T cells/million cells Standard Deviation 281.827	1570.631 CD4+ T cells/million cells Standard Deviation 1064.327	742.666 CD4+ T cells/million cells Standard Deviation 527.567	—
Frequency of CD4+ T-cells Against NTHi and Mcat Antigens for Evaluation of CMI Response, at One-month Post Dose 2 of NTHi-Mcat Vaccine NTHi.PE - CD4+ T-cells	565.964 CD4+ T cells/million cells Standard Deviation 411.715	581.338 CD4+ T cells/million cells Standard Deviation 520.594	888.057 CD4+ T cells/million cells Standard Deviation 154.524	1155.341 CD4+ T cells/million cells Standard Deviation 699.841	—
Frequency of CD4+ T-cells Against NTHi and Mcat Antigens for Evaluation of CMI Response, at One-month Post Dose 2 of NTHi-Mcat Vaccine NTHi.PilA - CD4+ T-cells	332.43 CD4+ T cells/million cells Standard Deviation 273.215	318.46 CD4+ T cells/million cells Standard Deviation 195.527	333.501 CD4+ T cells/million cells Standard Deviation 121.712	388.282 CD4+ T cells/million cells Standard Deviation 207.434	—

SECONDARY outcome

Timeframe: During the 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after Dose 1 and after Dose 2 of NTHi-Mcat vaccine

Population: Analysis was performed on the Solicited safety set (SSS) which included all subjects who received at least 1 dose of the study treatment and who have solicited safety data

The percentage of subjects with at least one local solicited AE, regardless of intensity, during the 7-day follow-up period after each NTHi-Mcat vaccine dose, are reported by study group. Assessed local symptoms were pain, redness and swelling. Any local injection site redness/swelling is scored as follows: diameter \>=20 milli-meters

Outcome measures

Outcome measures
Measure	Sh_NTHi-Mcat_1 Group n=134 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	NTHi-Mcat Group n=133 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Sh_NTHi-Mcat_6 Group n=118 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group n=135 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Percentage of Subjects With Reported Solicited Local Adverse Event (AE) Swelling (mm), Dose 2	7.5 Percentage of subjects Interval 3.7 to 13.4	8.4 Percentage of subjects Interval 4.3 to 14.5	6.8 Percentage of subjects Interval 3.0 to 13.0	7.9 Percentage of subjects Interval 3.8 to 14.0	—
Percentage of Subjects With Reported Solicited Local Adverse Event (AE) Erythema (mm), Dose 1	6 Percentage of subjects Interval 2.6 to 11.4	15 Percentage of subjects Interval 9.4 to 22.3	11 Percentage of subjects Interval 6.0 to 18.1	12.6 Percentage of subjects Interval 7.5 to 19.4	—
Percentage of Subjects With Reported Solicited Local Adverse Event (AE) Erythema (mm), Dose 2	12.8 Percentage of subjects Interval 7.6 to 19.7	13.7 Percentage of subjects Interval 8.4 to 20.8	17.9 Percentage of subjects Interval 11.5 to 26.1	11.8 Percentage of subjects Interval 6.8 to 18.7	—
Percentage of Subjects With Reported Solicited Local Adverse Event (AE) Pain, Dose 1	59.7 Percentage of subjects Interval 50.9 to 68.1	69.2 Percentage of subjects Interval 60.6 to 76.9	61 Percentage of subjects Interval 51.6 to 69.9	63.7 Percentage of subjects Interval 55.0 to 71.8	—
Percentage of Subjects With Reported Solicited Local Adverse Event (AE) Pain, Dose 2	69.9 Percentage of subjects Interval 61.4 to 77.6	76.3 Percentage of subjects Interval 68.1 to 83.3	72.6 Percentage of subjects Interval 63.6 to 80.5	75.6 Percentage of subjects Interval 67.2 to 82.8	—
Percentage of Subjects With Reported Solicited Local Adverse Event (AE) Swelling (mm), Dose 1	3.7 Percentage of subjects Interval 1.2 to 8.5	10.5 Percentage of subjects Interval 5.9 to 17.0	5.9 Percentage of subjects Interval 2.4 to 11.8	5.2 Percentage of subjects Interval 2.1 to 10.4	—

SECONDARY outcome

Timeframe: During the 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after Dose 1 and after Dose 2 of NTHi-Mcat vaccine

Population: Analysis was performed on the SSS which included all subjects who received at least 1 dose of the study treatment and who have solicited safety data

The percentage of subjects with at least one general solicited AE, regardless of intensity, during the 7-day follow-up period after each NTHi-Mcat vaccine dose, are reported by study group. Assessed solicited general symptoms were Fatigue, Gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), Headache, Myalgia, Chills and Fever (oral cavity or axillary route - temperature equal or higher than \[\>=\] 37.5 degrees Celsius \[°C\])

Outcome measures

Outcome measures
Measure	Sh_NTHi-Mcat_1 Group n=134 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	NTHi-Mcat Group n=133 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Sh_NTHi-Mcat_6 Group n=118 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group n=135 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Percentage of Subjects With Reported Solicited General AE Headache, Dose 2	32.3 Percentage of subjects Interval 24.5 to 41.0	38.2 Percentage of subjects Interval 29.8 to 47.1	23.9 Percentage of subjects Interval 16.5 to 32.7	22 Percentage of subjects Interval 15.2 to 30.3	—
Percentage of Subjects With Reported Solicited General AE Myalgia, Dose 2	33.1 Percentage of subjects Interval 25.2 to 41.8	37.4 Percentage of subjects Interval 29.1 to 46.3	36.8 Percentage of subjects Interval 28.0 to 46.2	37.8 Percentage of subjects Interval 29.3 to 46.8	—
Percentage of Subjects With Reported Solicited General AE Chills, Dose 1	11.9 Percentage of subjects Interval 7.0 to 18.7	12 Percentage of subjects Interval 7.0 to 18.8	16.9 Percentage of subjects Interval 10.7 to 25.0	7.4 Percentage of subjects Interval 3.6 to 13.2	—
Percentage of Subjects With Reported Solicited General AE Chills, Dose 2	25.6 Percentage of subjects Interval 18.4 to 33.8	26 Percentage of subjects Interval 18.7 to 34.3	22.2 Percentage of subjects Interval 15.1 to 30.8	16.5 Percentage of subjects Interval 10.5 to 24.2	—
Percentage of Subjects With Reported Solicited General AE Fatigue, Dose 1	26.1 Percentage of subjects Interval 18.9 to 34.4	38.3 Percentage of subjects Interval 30.1 to 47.2	39 Percentage of subjects Interval 30.1 to 48.4	34.1 Percentage of subjects Interval 26.1 to 42.7	—
Percentage of Subjects With Reported Solicited General AE Fatigue, Dose 2	39.1 Percentage of subjects Interval 30.8 to 47.9	48.1 Percentage of subjects Interval 39.3 to 57.0	43.6 Percentage of subjects Interval 34.4 to 53.1	37.8 Percentage of subjects Interval 29.3 to 46.8	—
Percentage of Subjects With Reported Solicited General AE Fever (C), Dose 1	1.5 Percentage of subjects Interval 0.2 to 5.3	1.5 Percentage of subjects Interval 0.2 to 5.3	2.5 Percentage of subjects Interval 0.5 to 7.3	3 Percentage of subjects Interval 0.8 to 7.4	—
Percentage of Subjects With Reported Solicited General AE Fever (C), Dose 2	11.3 Percentage of subjects Interval 6.5 to 17.9	8.4 Percentage of subjects Interval 4.3 to 14.5	8.5 Percentage of subjects Interval 4.2 to 15.2	8.7 Percentage of subjects Interval 4.4 to 15.0	—
Percentage of Subjects With Reported Solicited General AE Gastrointestinal symptoms, Dose 1	13.4 Percentage of subjects Interval 8.2 to 20.4	13.5 Percentage of subjects Interval 8.2 to 20.5	16.1 Percentage of subjects Interval 10.0 to 24.0	13.3 Percentage of subjects Interval 8.1 to 20.3	—
Percentage of Subjects With Reported Solicited General AE Gastrointestinal symptoms, Dose 2	15.8 Percentage of subjects Interval 10.0 to 23.1	15.3 Percentage of subjects Interval 9.6 to 22.6	12.8 Percentage of subjects Interval 7.4 to 20.3	9.4 Percentage of subjects Interval 5.0 to 15.9	—
Percentage of Subjects With Reported Solicited General AE Headache, Dose 1	20.9 Percentage of subjects Interval 14.4 to 28.8	26.3 Percentage of subjects Interval 19.1 to 34.7	22.9 Percentage of subjects Interval 15.7 to 31.5	18.5 Percentage of subjects Interval 12.4 to 26.1	—
Percentage of Subjects With Reported Solicited General AE Myalgia, Dose 1	20.1 Percentage of subjects Interval 13.7 to 27.9	23.3 Percentage of subjects Interval 16.4 to 31.4	25.4 Percentage of subjects Interval 17.9 to 34.3	27.4 Percentage of subjects Interval 20.1 to 35.7	—

SECONDARY outcome

Timeframe: During the 30-day follow-up period (i.e. day of vaccination and 29 subsequent days) after Dose 1 and after Dose 2 of NTHi-Mcat vaccine

Population: Analysis was performed on the Unsolicited safety set which included all subjects who receive at least 1 dose of the study treatment and who have unsolicited safety data

An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. The percentage of subjects with at least one unsolicited AE, regardless of intensity or relationship to vaccination, during the 30-day follow-up period after any NTHi-Mcat vaccine dose are reported for each group. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event

Outcome measures

Outcome measures
Measure	Sh_NTHi-Mcat_1 Group n=134 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	NTHi-Mcat Group n=134 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Sh_NTHi-Mcat_6 Group n=122 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group n=135 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Percentage of Subjects With Any Unsolicited AE Dose 1	13.4 Percentage of subjects Interval 8.2 to 20.4	14.9 Percentage of subjects Interval 9.4 to 22.1	11.5 Percentage of subjects Interval 6.4 to 18.5	18.5 Percentage of subjects Interval 12.4 to 26.1	—
Percentage of Subjects With Any Unsolicited AE Dose 2	15 Percentage of subjects Interval 9.4 to 22.3	15.3 Percentage of subjects Interval 9.6 to 22.6	8.5 Percentage of subjects Interval 4.1 to 15.0	10.9 Percentage of subjects Interval 6.1 to 17.5	—

SECONDARY outcome

Timeframe: From Day 1 up to and including Day 331 (Epoch 001)

Population: Analysis was performed on the Exposed Set (ES) which included all subjects who received at least 1 dose of the study treatment.

The percentage of subjects with at least one SAE, regardless of intensity or relationship to vaccination, from Day 1 up to and including Day 331, were reported for each group An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject or was a congenital anomaly/birth defect in the offspring of a study subject. AE(s) considered as SAE(s) also include invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, as per the medical or scientific judgement of the physician

Outcome measures

Outcome measures
Measure	Sh_NTHi-Mcat_1 Group n=134 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	NTHi-Mcat Group n=134 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Sh_NTHi-Mcat_6 Group n=122 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group n=135 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group n=16 Participants Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Percentage of Subjects With Any Serious Adverse Event (SAE) During Epoch 001	4.5 Percentage of subjects Interval 1.7 to 9.5	3.7 Percentage of subjects Interval 1.2 to 8.5	2.5 Percentage of subjects Interval 0.5 to 7.0	1.5 Percentage of subjects Interval 0.2 to 5.2	6.3 Percentage of subjects Interval 0.2 to 30.2

SECONDARY outcome

Timeframe: From Day 1 up to and including Day 331 (Epoch 001)

Population: Analysis was performed on the ES which included all subjects who received at least 1 dose of the study treatment.

pIMD's are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

Outcome measures

Outcome measures
Measure	Sh_NTHi-Mcat_1 Group n=134 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	NTHi-Mcat Group n=134 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Sh_NTHi-Mcat_6 Group n=122 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group n=135 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group n=16 Participants Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Percentage of Subjects With Any Potential Immune-mediated Diseases (pIMD's) During Epoch 001	0 Percentage of subjects Interval 0.0 to 2.7	1.5 Percentage of subjects Interval 0.2 to 5.3	0.8 Percentage of subjects Interval 0.0 to 4.5	0 Percentage of subjects Interval 0.0 to 2.7	12.5 Percentage of subjects Interval 1.6 to 38.3

SECONDARY outcome

Timeframe: From Day 332 up to and including Day 661 (Epoch 002)

Population: Analysis was performed on the ES which included all subjects who received at least 1 dose of the study treatment.

The percentage of subjects with at least one SAE, regardless of intensity or relationship to vaccination, from Day 332 up to and including Day 661, are reported for each group. An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, requires hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject or was a congenital anomaly/birth defect in the offspring of a study subject. AE(s) considered as SAE(s) also include invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, as per the medical or scientific judgement of the physician.

Outcome measures

Outcome measures
Measure	Sh_NTHi-Mcat_1 Group n=134 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	NTHi-Mcat Group n=134 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Sh_NTHi-Mcat_6 Group n=122 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group n=135 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group n=16 Participants Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Percentage of Subjects With Any SAE During Epoch 002	3.0 Percentage of subjects Interval 0.8 to 7.5	4.5 Percentage of subjects Interval 1.7 to 9.5	3.3 Percentage of subjects Interval 0.9 to 8.2	2.2 Percentage of subjects Interval 0.5 to 6.4	0.0 Percentage of subjects Interval 0.0 to 20.6

SECONDARY outcome

Timeframe: From Day 332 up to and including Day 661 (Epoch 002)

Population: Analysis was performed on the ES which included all subjects who received at least 1 dose of the study treatment.

pIMD's are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology

Outcome measures

Outcome measures
Measure	Sh_NTHi-Mcat_1 Group n=134 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	NTHi-Mcat Group n=134 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Sh_NTHi-Mcat_6 Group n=122 Participants Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group n=135 Participants Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group n=16 Participants Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Percentage of Subjects With Any pIMD's During Epoch 002	0.7 Percentage of subjects Interval 0.0 to 4.1	0.7 Percentage of subjects Interval 0.0 to 4.1	0.0 Percentage of subjects Interval 0.0 to 3.0	0.0 Percentage of subjects Interval 0.0 to 2.7	0.0 Percentage of subjects Interval 0.0 to 20.6

Adverse Events

Sh_NTHi-Mcat_1 Group

Serious events: 9 serious events

Other events: 118 other events

Deaths: 0 deaths

Sh_NTHi-Mcat_3 Group

Serious events: 11 serious events

Other events: 125 other events

Deaths: 1 deaths

Sh_NTHi-Mcat_6 Group

Serious events: 6 serious events

Other events: 107 other events

Deaths: 0 deaths

NTHi-Mcat Group

Serious events: 5 serious events

Other events: 125 other events

Deaths: 0 deaths

Shingrix-Only Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sh_NTHi-Mcat_1 Group n=134 participants at risk Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	Sh_NTHi-Mcat_3 Group n=134 participants at risk Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 3-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 151 and Day 211.	Sh_NTHi-Mcat_6 Group n=122 participants at risk Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group n=135 participants at risk Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group n=16 participants at risk Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Skin and subcutaneous tissue disorders Skin necrosis	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Appendicitis	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations COVID-19	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations COVID-19 pneumonia	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Pulmonary tuberculosis	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Urinary tract infection	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	6.2% 1/16 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	1.5% 2/134 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Cardiac disorders Acute myocardial infarction	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Cardiac disorders Atrial fibrillation	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	1.6% 2/122 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Injury, poisoning and procedural complications Peripheral artery restenosis	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Nervous system disorders Ruptured cerebral aneurysm	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenoma	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Cardiac disorders Arteriosclerosis coronary artery	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Cardiac disorders Cardiac failure	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Cardiac disorders Stress cardiomyopathy	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Nervous system disorders Cerebral infarction	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Nervous system disorders Cognitive disorder	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Nervous system disorders Intracranial aneurysm	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Eye disorders Macular hole	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Eye disorders Retinal detachment	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Vascular disorders Embolism venous	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Vascular disorders Giant cell arteritis	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Gastrointestinal disorders Abdominal hernia	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Renal and urinary disorders Calculus urinary	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/16 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.

Other adverse events

Other adverse events
Measure	Sh_NTHi-Mcat_1 Group n=134 participants at risk Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61, and following a 1-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 91, and Day 151.	Sh_NTHi-Mcat_3 Group n=134 participants at risk Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 3-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 151 and Day 211.	Sh_NTHi-Mcat_6 Group n=122 participants at risk Subjects enrolled in this group received 2 doses of GSK Biologicals' Shingrix vaccine at Day 1 and Day 61 and, following a 6-month gap, subjects received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart at Day 241 and Day 301.	NTHi-Mcat Group n=135 participants at risk Subjects enrolled in this group received 2 doses of GSK Biological's NTHi-Mcat investigational vaccine 2 months apart, at Day 1 and Day 61.	Shingrix-Only Group n=16 participants at risk Subjects belonging to this group were originally randomized to either Sh\_NTHi-Mcat\_1 Group, Sh\_NTHi-Mcat\_3 Group or Sh\_NTHi-Mcat\_6 Group, they received at least 1, maximum 2 doses of GSK Biologicals Shingrix vaccine at Day 1 and Day 61, but didnt receive any dose of NTHi Mcat investigational vaccine. Only safety data were collected for these subjects.
Cardiac disorders Extrasystoles	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Ear and labyrinth disorders Ear pain	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Ear and labyrinth disorders Ear pruritus	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Ear and labyrinth disorders Vertigo	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Endocrine disorders Basedow's disease	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Eye disorders Blepharospasm	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Eye disorders Chalazion	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Eye disorders Eye pain	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Eye disorders Eyelid ptosis	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Eye disorders Swelling of eyelid	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Gastrointestinal disorders Abdominal pain upper	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Gastrointestinal disorders Constipation	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Gastrointestinal disorders Diarrhoea	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Gastrointestinal disorders Dyspepsia	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Gastrointestinal disorders Gastritis	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	2.2% 3/134 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Gastrointestinal disorders Gastrointestinal disorder	25.4% 34/134 • Number of events 39 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	23.9% 32/134 • Number of events 38 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	21.3% 26/122 • Number of events 34 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	19.3% 26/135 • Number of events 30 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Gastrointestinal disorders Nausea	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Gastrointestinal disorders Tooth disorder	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Gastrointestinal disorders Toothache	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	1.6% 2/122 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
General disorders Asthenia	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
General disorders Chest discomfort	0.75% 1/134 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
General disorders Chest pain	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	1.6% 2/122 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
General disorders Chills	29.9% 40/134 • Number of events 50 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	30.6% 41/134 • Number of events 50 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	32.8% 40/122 • Number of events 47 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	19.3% 26/135 • Number of events 31 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
General disorders Discomfort	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
General disorders Fatigue	47.0% 63/134 • Number of events 88 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	58.2% 78/134 • Number of events 114 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	55.7% 68/122 • Number of events 99 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	48.1% 65/135 • Number of events 95 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
General disorders Feeling hot	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
General disorders Hangover	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
General disorders Influenza like illness	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
General disorders Injection site erythema	15.7% 21/134 • Number of events 25 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	20.1% 27/134 • Number of events 38 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	23.0% 28/122 • Number of events 34 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	17.8% 24/135 • Number of events 32 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
General disorders Injection site movement impairment	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
General disorders Injection site pain	78.4% 105/134 • Number of events 173 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	83.6% 112/134 • Number of events 192 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	80.3% 98/122 • Number of events 157 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	83.0% 112/135 • Number of events 182 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
General disorders Injection site pruritus	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
General disorders Injection site swelling	9.0% 12/134 • Number of events 15 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	14.2% 19/134 • Number of events 25 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	10.7% 13/122 • Number of events 15 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	11.1% 15/135 • Number of events 17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
General disorders Malaise	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
General disorders Pyrexia	11.9% 16/134 • Number of events 17 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	9.0% 12/134 • Number of events 13 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	10.7% 13/122 • Number of events 13 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	10.4% 14/135 • Number of events 15 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Immune system disorders Seasonal allergy	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Bacterial vaginosis	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Bronchitis	2.2% 3/134 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Cystitis	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Dengue fever	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Gastroenteritis	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Genital herpes	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Herpes simplex	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Influenza	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Nasopharyngitis	2.2% 3/134 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	2.2% 3/134 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	1.6% 2/122 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Oral herpes	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Otitis media	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Pulpitis dental	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Respiratory tract infection	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Rhinitis	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	2.2% 3/135 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Schistosomiasis cutaneous	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Tonsillitis	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	1.5% 2/135 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Tooth abscess	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Upper respiratory tract infection	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Urinary tract infection	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Viral infection	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	2.2% 3/135 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Injury, poisoning and procedural complications Fall	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Injury, poisoning and procedural complications Head injury	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Injury, poisoning and procedural complications Lower limb fracture	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Injury, poisoning and procedural complications Procedural pain	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Injury, poisoning and procedural complications Thermal burn	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Investigations Weight increased	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Metabolism and nutrition disorders Metabolic syndrome	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Musculoskeletal and connective tissue disorders Arthralgia	1.5% 2/134 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	2.2% 3/134 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Musculoskeletal and connective tissue disorders Back pain	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	2.2% 3/135 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Musculoskeletal and connective tissue disorders Muscle contracture	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Musculoskeletal and connective tissue disorders Myalgia	35.8% 48/134 • Number of events 73 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	47.8% 64/134 • Number of events 80 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	45.9% 56/122 • Number of events 76 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	49.6% 67/135 • Number of events 87 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	2.2% 3/134 • Number of events 4 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Nervous system disorders Balance disorder	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Nervous system disorders Dizziness	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Nervous system disorders Headache	41.8% 56/134 • Number of events 78 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	49.3% 66/134 • Number of events 92 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	36.1% 44/122 • Number of events 59 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	31.1% 42/135 • Number of events 56 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Nervous system disorders Somnolence	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Nervous system disorders Syncope	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Respiratory, thoracic and mediastinal disorders Catarrh	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Respiratory, thoracic and mediastinal disorders Cough	2.2% 3/134 • Number of events 3 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	1.5% 2/135 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Respiratory, thoracic and mediastinal disorders Productive cough	1.5% 2/134 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Skin and subcutaneous tissue disorders Eczema	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Skin and subcutaneous tissue disorders Erythema	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	1.5% 2/135 • Number of events 2 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Skin and subcutaneous tissue disorders Rash	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.74% 1/135 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Surgical and medical procedures Dental implantation	0.75% 1/134 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/122 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.
Vascular disorders Hypertension	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/134 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.82% 1/122 • Number of events 1 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	0.00% 0/135 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.	— 0/0 • Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 661. Other Adverse events were not collected for Shingrix-Only Group.

Additional Information

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GlaxoSmithKline

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Email: [email protected]

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.
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