Trial Outcomes & Findings for Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above (NCT NCT04732871)

NCT ID: NCT04732871

Last Updated: 2023-12-21

Results Overview

RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 1720 participants
• Primary outcome timeframe: At Day 1
• Results posted on: 2023-12-21

Participant Flow

The demography, immunogenicity, reactogenicity and safety data currently presented is reported only for the first 12 months of the study timeline. The follow-up data (up to 36 months) will be updated during final posting.

Out of 1720 participants enrolled in the study, 1653 participants received the study vaccination and were included in the Exposed Set.

Participant milestones

Measure	RSV_annual Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Overall Study STARTED	993	329	331
Overall Study COMPLETED	938	317	317
Overall Study NOT COMPLETED	55	12	14

Reasons for withdrawal

Measure	RSV_annual Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Overall Study Adverse event (AE) requiring expedited reporting	9	1	3
Overall Study Lost to Follow-up	7	4	3
Overall Study Consent withdrawal, not due to a serious adverse event (SAE)	26	7	6
Overall Study Migrated / moved from the study area	5	0	0
Overall Study Other	1	0	1
Overall Study Ongoing	6	0	1
Overall Study Unsolicited non-serious adverse event	1	0	0

Baseline Characteristics

Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

Baseline characteristics by cohort

Measure	RSV_annual n=993 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=329 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=331 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).	Total n=1653 Participants Total of all reporting groups
Age, Continuous	70.1 YEARS STANDARD_DEVIATION 6.6 • n=5 Participants	69.9 YEARS STANDARD_DEVIATION 6.7 • n=7 Participants	69.9 YEARS STANDARD_DEVIATION 6.7 • n=5 Participants	70.0 YEARS STANDARD_DEVIATION 6.6 • n=4 Participants
Sex: Female, Male Female	542 Participants n=5 Participants	182 Participants n=7 Participants	180 Participants n=5 Participants	904 Participants n=4 Participants
Sex: Female, Male Male	451 Participants n=5 Participants	147 Participants n=7 Participants	151 Participants n=5 Participants	749 Participants n=4 Participants
Race/Ethnicity, Customized American Indian Or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Asian	296 Participants n=5 Participants	102 Participants n=7 Participants	98 Participants n=5 Participants	496 Participants n=4 Participants
Race/Ethnicity, Customized Black Or African American	19 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	33 Participants n=4 Participants
Race/Ethnicity, Customized Other - Unspecified	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White	676 Participants n=5 Participants	219 Participants n=7 Participants	226 Participants n=5 Participants	1121 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Day 1

Population: Analysis was performed on the per-protocol (PP)-humoral immunity (HI) set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Day 1 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.

RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Outcome measures

Measure	RSV_annual n=342 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=321 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=319 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1	832.4 Titers (ED60) Interval 763.4 to 907.7	864.9 Titers (ED60) Interval 790.6 to 946.1	896.8 Titers (ED60) Interval 815.9 to 985.8

PRIMARY outcome

Timeframe: At Day 31

Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Day 31 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.

RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.

Outcome measures

Measure	RSV_annual n=328 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=300 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=309 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31	8827.2 Titers (ED60) Interval 7905.0 to 9857.0	8906.6 Titers (ED60) Interval 7972.3 to 9950.3	9585.6 Titers (ED60) Interval 8448.8 to 10875.5

PRIMARY outcome

Timeframe: At Month 6

Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Month 6 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.

RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.

Outcome measures

Measure	RSV_annual n=319 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=294 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=311 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6	3465.2 Titers (ED60) Interval 3140.9 to 3823.0	3600.1 Titers (ED60) Interval 3242.2 to 3997.5	4223.1 Titers (ED60) Interval 3795.3 to 4699.0

PRIMARY outcome

Timeframe: At Month 12

Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Month 12 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.

RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.

Outcome measures

Measure	RSV_annual n=284 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=291 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=296 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12	2529.9 Titers (ED60) Interval 2274.5 to 2814.0	2695.7 Titers (ED60) Interval 2421.4 to 3001.0	2800.1 Titers (ED60) Interval 2501.6 to 3134.3

PRIMARY outcome

Timeframe: At Day 1

Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Day 1 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.

RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

Outcome measures

Measure	RSV_annual n=342 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=321 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=320 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1	1138.7 Titers (ED60) Interval 1046.2 to 1239.3	1325.9 Titers (ED60) Interval 1206.9 to 1456.6	1258.7 Titers (ED60) Interval 1142.0 to 1387.4

PRIMARY outcome

Timeframe: At Day 31

Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Day 31 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.

RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

Outcome measures

Measure	RSV_annual n=328 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=300 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=309 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31	9219.7 Titers (ED60) Interval 8368.7 to 10157.3	9955.2 Titers (ED60) Interval 9002.1 to 11009.3	9756.1 Titers (ED60) Interval 8785.4 to 10834.0

PRIMARY outcome

Timeframe: At Month 6

Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Month 6 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.

RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

Outcome measures

Measure	RSV_annual n=319 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=294 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=311 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6	3886.4 Titers (ED60) Interval 3563.5 to 4238.6	4484.6 Titers (ED60) Interval 4063.8 to 4949.0	4570.6 Titers (ED60) Interval 4152.0 to 5031.4

PRIMARY outcome

Timeframe: At Month 12

Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Month 12 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.

RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

Outcome measures

Measure	RSV_annual n=284 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=291 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=296 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 12	2671.4 Titers (ED60) Interval 2433.3 to 2932.9	3015.4 Titers (ED60) Interval 2737.9 to 3321.0	2977.1 Titers (ED60) Interval 2669.6 to 3320.0

SECONDARY outcome

Timeframe: At Day 1

Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Day 1 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.

Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by enzyme-linked immunosorbent assay (ELISA). The corresponding antibody GMC was expressed in Elisa Laboratory Units/milliliter (ELU/mL).

Outcome measures

Measure	RSV_annual n=342 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=320 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=320 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Humoral Immune Response in Terms of RSVPreF3 Immunoglobulin G (IgG) Antibody Geometric Mean Concentrations (GMCs) at Day 1	7334.7 ELU/mL Interval 6868.3 to 7832.8	7437.1 ELU/mL Interval 6948.6 to 7959.9	7759 ELU/mL Interval 7212.5 to 8346.8

SECONDARY outcome

Timeframe: At Day 31

Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Day 31 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.

Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Outcome measures

Measure	RSV_annual n=328 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=300 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=309 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Day 31	86929.7 ELU/mL Interval 80662.7 to 93683.6	92664.7 ELU/mL Interval 86050.1 to 99787.8	94249.4 ELU/mL Interval 87660.7 to 101333.3

SECONDARY outcome

Timeframe: At Month 6

Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Month 6 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.

Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Outcome measures

Measure	RSV_annual n=319 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=294 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=311 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 6	33855.9 ELU/mL Interval 31405.3 to 36497.7	35193.5 ELU/mL Interval 32623.6 to 37965.9	36525.7 ELU/mL Interval 33938.0 to 39310.7

SECONDARY outcome

Timeframe: At Month 12

Population: Analysis was performed on the PP-HI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of humoral immunity at Month 12 and for whom immunogenicity results were available for the specified assay, minus participants with protocol deviations that lead to exclusion.

Serological assays for the determination of IgG antibodies against RSV PreF3 are performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Outcome measures

Measure	RSV_annual n=284 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=291 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=296 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 12	24733.5 ELU/mL Interval 22994.3 to 26604.2	26484.1 ELU/mL Interval 24651.7 to 28452.8	27360.3 ELU/mL Interval 25476.7 to 29383.0

SECONDARY outcome

Timeframe: At Month 18

Month 18 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 24

Month 24 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 30

Month 30 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 36

Month 36 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 13

Month 13 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 25

Month 25 data will be disclosed during final posting. RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 18

Month 18 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 24

Month 24 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 30

Month 30 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 36

Month 36 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 13

Month 13 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 25

Month 25 data will be disclosed during final posting. RSV-B neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 18

Month 18 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 24

Month 24 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 30

Month 30 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 36

Month 36 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 13

Month 13 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 25

Month 25 data will be disclosed during final posting. Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by ELISA. The corresponding antibody GMC was expressed in ELU/mL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Day 1

Population: Analysis was performed on the PP-CMI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of CMI at Day 1, minus participants with protocol deviations that lead to exclusion.

Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Measure	RSV_annual n=287 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=93 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=95 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Cell-Mediated Immunity (CMI) Response in Terms of Frequency of RSVPreF3-specific Cluster of Differentiation CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1	202 CD4 atl2_7m/ million of CD4+ cells Interval 83.0 to 376.0	143 CD4 atl2_7m/ million of CD4+ cells Interval 26.0 to 294.0	171 CD4 atl2_7m/ million of CD4+ cells Interval 65.0 to 385.0

SECONDARY outcome

Timeframe: At Day 1

Population: Analysis was performed on the PP-CMI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of CMI at Day 1, minus participants with protocol deviations that lead to exclusion.

Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Measure	RSV_annual n=287 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=93 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=95 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 1	33 CD8 atl2_7m/ million of CD8+ cells Interval 1.0 to 110.0	32 CD8 atl2_7m/ million of CD8+ cells Interval 1.0 to 103.0	2 CD8 atl2_7m/ million of CD8+ cells Interval 1.0 to 107.0

SECONDARY outcome

Timeframe: At Day 31

Population: Analysis was performed on the PP-CMI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of CMI at Day 31, minus participants with protocol deviations that lead to exclusion.

Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Measure	RSV_annual n=245 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=81 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=84 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31	1310 CD4 atl2_7m/ million of CD4+ cells Interval 813.0 to 2155.0	1292.5 CD4 atl2_7m/ million of CD4+ cells Interval 820.5 to 2254.0	1570 CD4 atl2_7m/ million of CD4+ cells Interval 876.0 to 1971.0

SECONDARY outcome

Timeframe: At Day 31

Population: Analysis was performed on the PP-CMI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of CMI at Day 31, minus participants with protocol deviations that lead to exclusion.

Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Measure	RSV_annual n=245 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=81 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=84 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Day 31	26 CD8 atl2_7m/ million of CD8+ cells Interval 1.0 to 129.0	58 CD8 atl2_7m/ million of CD8+ cells Interval 1.0 to 143.0	5 CD8 atl2_7m/ million of CD8+ cells Interval 1.0 to 101.0

SECONDARY outcome

Timeframe: At Month 6

Population: Analysis was performed on the PP-CMI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of CMI at Month 6, minus participants with protocol deviations that lead to exclusion.

Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Measure	RSV_annual n=263 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=87 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=86 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6	662 CD4 atl2_7m/ million of CD4+ cells Interval 428.0 to 1026.0	644 CD4 atl2_7m/ million of CD4+ cells Interval 442.0 to 1100.0	695 CD4 atl2_7m/ million of CD4+ cells Interval 427.0 to 1131.0

SECONDARY outcome

Timeframe: At Month 6

Population: Analysis was performed on the PP-CMI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of CMI at Month 6, minus participants with protocol deviations that lead to exclusion.

Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Measure	RSV_annual n=248 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=88 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=85 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 6	38 CD8 atl2_7m/ million of CD8+ cells Interval 1.0 to 113.0	24.5 CD8 atl2_7m/ million of CD8+ cells Interval 1.0 to 103.5	26 CD8 atl2_7m/ million of CD8+ cells Interval 1.0 to 87.0

SECONDARY outcome

Timeframe: At Month 12

Population: Analysis was performed on the PP-CMI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of CMI at Month 12, minus participants with protocol deviations that lead to exclusion.

Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Measure	RSV_annual n=257 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=94 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=92 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
CMI Response in Terms of Frequency of RSVPreF3-specific CD4 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12	564 CD4 atl2_7m/ million of CD4+ cells Interval 348.0 to 898.0	525 CD4 atl2_7m/ million of CD4+ cells Interval 345.0 to 818.0	671 CD4 atl2_7m/ million of CD4+ cells Interval 374.5 to 1072.5

SECONDARY outcome

Timeframe: At Month 12

Population: Analysis was performed on the PP-CMI set, which included participants from the RSV\_annual Group, the RSV\_flexible revaccination Group and the RSV\_1dose Group who had blood samples collected for testing of CMI at Month 12, minus participants with protocol deviations that lead to exclusion.

Among markers expressed were IL2, IL13, IL17, CD40L, 41BB, TNF α and IFN γ, in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Measure	RSV_annual n=257 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=94 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=92 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
CMI Response in Terms of Frequency of RSVPreF3-specific CD8 atl2_7m T Cells Expressing at Least 2 Activation Markers at Month 12	1 CD8 atl2_7m/ million of CD8+ cells Interval 1.0 to 81.0	18 CD8 atl2_7m/ million of CD8+ cells Interval 1.0 to 108.0	22 CD8 atl2_7m/ million of CD8+ cells Interval 1.0 to 104.0

SECONDARY outcome

Timeframe: At Month 18

Month 18 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 18

Month 18 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 24

Month 24 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 24

Month 24 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 30

Month 30 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 30

Month 30 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 36

Month 36 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 36

Month 36 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 13

Month 13 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 13

Month 13 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 25

Month 25 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Month 25

Month 25 data will be disclosed during final posting. Among markers expressed were interleukin-2/13/17 (IL2, IL13, IL17), cluster of 40 ligand (CD40L), 41BB, tumor necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the 4-day follow up period after first vaccination (vaccine administered on Day 1)

Population: The analysis was performed on the Exposed Set (ES), which included all participants who received at least 1 dose of the study intervention and for whom solicited administration-site data was available for the specific duration.

The solicited administration-site events were erythema, pain and swelling at the injection site.

Outcome measures

Measure	RSV_annual n=989 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=328 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=329 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1 Erythema	99 Participants	38 Participants	22 Participants
Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1 Pain	595 Participants	201 Participants	200 Participants
Number of Participants With at Least One Solicited Administration-site Event Following Vaccination at Day 1 Swelling	75 Participants	33 Participants	16 Participants

SECONDARY outcome

Timeframe: During the 4-day follow up period after vaccination (vaccine administered at Month 12)

Month 12 to Month 18 data will be disclosed during final posting. The solicited administration-site events were erythema, pain and swelling at the injection site.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the 4-day follow up period after vaccination (vaccine administered at Month 24)

Month 24 data will be disclosed during final posting. The solicited administration-site events were erythema, pain and swelling at the injection site.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the 4-day follow up period after vaccination (vaccine administered on Day 1)

Population: The analysis was performed on the ES, which included all participants who received at least 1 dose of the study intervention and for whom solicited systemic data was available for the specific duration.

The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0 degree Celsius [°C]), headache and myalgia.

Outcome measures

Measure	RSV_annual n=989 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=328 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=329 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 Myalgia	336 Participants	107 Participants	109 Participants
Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 Arthralgia	157 Participants	49 Participants	49 Participants
Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 Fatigue	307 Participants	100 Participants	110 Participants
Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 Fever	13 Participants	5 Participants	7 Participants
Number of Participants With at Least One Solicited Systemic Event Following Vaccination at Day 1 Headache	187 Participants	70 Participants	79 Participants

SECONDARY outcome

Timeframe: During the 4-day follow up period after vaccination (vaccine administered at Month 12)

Month 12 to Month 18 data will be disclosed during final posting. The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0°C), headache and myalgia.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the 4-day follow up period after vaccination (vaccine administered at Month 24)

Month 24 data will be disclosed during final posting. The solicited systemic events included arthralgia, fatigue, fever (defined as temperature equal to or above 38.0 degree Celsius (°C)), headache and myalgia.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the 30-day follow up period after vaccination (vaccine administered on Day 1)

Population: The analysis was performed on the ES, which included all participants who received at least 1 dose of the study intervention and for whom safety data was available for 30 days following vaccination at Day 1.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	RSV_annual n=993 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=329 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=331 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Number of Participants With Any Unsolicited Adverse Events (AEs) Following Vaccination at Day 1	125 Participants	45 Participants	55 Participants

SECONDARY outcome

Timeframe: During the 4-day follow up period after vaccination (vaccine administered at Month 12)

Month 12 to Month 18 data will be disclosed during final posting. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the 4-day follow up period after vaccination (vaccine administered at Month 24)

Month 24 data will be disclosed during final posting. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of study intervention, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study, and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6)

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

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study participant.

Outcome measures

Measure	RSV_annual n=993 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=329 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=331 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Number of Participants With Serious Adverse Events (SAE) Following Vaccination at Day 1	36 Participants	16 Participants	15 Participants

SECONDARY outcome

Timeframe: During the 4-day follow up period after vaccination (vaccine administered at Month 12)

Month 12 to Month 18 data will be disclosed during final posting. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the 4-day follow up period after vaccination (vaccine administered at Month 24)

Month 24 data will be disclosed during final posting. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to 6 months post-Dose 1 (Month 6)

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

pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Outcome measures

Measure	RSV_annual n=993 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=329 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=331 Participants Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Number of Participants Reporting Any Potential Immune-mediated Disease (pIMD) Following Vaccination at Day 1	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 4-day follow up period after vaccination (vaccine administered at Month 12)

Month 12 to Month 18 data will be disclosed during final posting. pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the 4-day follow up period after vaccination (vaccine administered at Month 24)

Month 24 data will be disclosed during final posting. pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first vaccination (Day 1) up to study end (Month 36)

A fatal SAE is any untoward medical occurrence that results in death. A related SAE is an SAE considered to be causally related to the study intervention. A related pIMD is a pIMD considered to be causally related to the study intervention.

The study is ongoing at the time of the results posting. Results for Months 18 up to study end (Month 36) will be updated during final posting.

Outcome measures

Outcome data not reported

Adverse Events

RSV_annual

Serious events: 46 serious events

Other events: 744 other events

Deaths: 3 deaths

RSV_flexible Revaccination

Serious events: 16 serious events

Other events: 251 other events

Deaths: 1 deaths

RSV_1dose

Serious events: 19 serious events

Other events: 253 other events

Deaths: 3 deaths

Serious adverse events

Measure	RSV_annual n=993 participants at risk Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=329 participants at risk Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=331 participants at risk Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Cardiac disorders Coronary artery disease	0.30% 3/993 • Number of events 3 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Cardiac disorders Atrial fibrillation	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.61% 2/329 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.60% 2/331 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Cardiac disorders Acute myocardial infarction	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Cardiac disorders Cardiac failure	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Cardiac disorders Myocardial infarction	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Cardiac disorders Cardiac arrest	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Cardiac disorders Angina pectoris	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Cardiac disorders Right ventricular failure	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Cardiac disorders Sinus arrest	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extranodal marginal zone B-cell lymphoma (BALT type)	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Iris neoplasm	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations COVID-19	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations COVID-19 pneumonia	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Cellulitis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Urinary tract infection	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Colonic abscess	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Helicobacter gastritis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Post procedural infection	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Craniofacial injury	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Hip fracture	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Multiple fractures	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Radius fracture	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Rib fracture	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Thermal burn	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Wound dehiscence	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Cerebrovascular accident	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Syncope	0.30% 3/993 • Number of events 3 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Cerebrospinal fluid leakage	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Guillain-Barre syndrome	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Loss of consciousness	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Parkinson's disease	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Polyneuropathy in malignant disease	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Osteoarthritis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Chondrolysis	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Osteochondrosis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Sacroiliac joint dysfunction	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Spinal stenosis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Diabetic gastroparesis	0.10% 1/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Gastric ulcer	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Small intestinal obstruction	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Vascular disorders Arteriosclerosis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Vascular disorders Hypertensive crisis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Vascular disorders Thrombosis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Death	0.70% 7/993 • Number of events 7 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	1.2% 4/329 • Number of events 4 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	1.5% 5/331 • Number of events 5 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Pyrexia	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Sudden cardiac death	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Blood and lymphatic system disorders Anaemia	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Blood and lymphatic system disorders Nephrogenic anaemia	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Blood and lymphatic system disorders Pancytopenia	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Hepatobiliary disorders Cholelithiasis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Metabolism and nutrition disorders Hypokalaemia	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Investigations Anticoagulation drug level above therapeutic	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Investigations International normalised ratio increased	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Product Issues Device malfunction	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Reproductive system and breast disorders Ovarian cyst	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Skin and subcutaneous tissue disorders Dermal cyst	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)

Other adverse events

Measure	RSV_annual n=993 participants at risk Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and were followed up until the study end (Month 36).	RSV_flexible Revaccination n=329 participants at risk Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and 1 revaccination dose at 24 months post-Dose 1 and were followed up until the study end (Month 36).	RSV_1dose n=331 participants at risk Participants received one dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until the study end (Month 36).
Infections and infestations Herpes simplex	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Kidney infection	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Onychomycosis	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Paronychia	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Periodontitis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Pneumonia	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Pneumonia aspiration	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Sinusitis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Arthralgia	16.3% 162/993 • Number of events 167 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	15.2% 50/329 • Number of events 51 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	15.1% 50/331 • Number of events 51 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Back pain	0.60% 6/993 • Number of events 6 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Myalgia	33.9% 337/993 • Number of events 339 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	32.8% 108/329 • Number of events 111 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	33.2% 110/331 • Number of events 110 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Pain in extremity	0.40% 4/993 • Number of events 4 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Neck pain	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.60% 2/331 • Number of events 4 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Tendon pain	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Muscle spasms	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Headache	19.3% 192/993 • Number of events 198 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	21.9% 72/329 • Number of events 77 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	24.5% 81/331 • Number of events 87 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Joint swelling	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Dizziness	0.40% 4/993 • Number of events 4 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.60% 2/331 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Muscle tightness	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Hypoaesthesia	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.60% 2/331 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Paraesthesia	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Chills	0.60% 6/993 • Number of events 6 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.91% 3/329 • Number of events 3 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Injection site pruritus	0.81% 8/993 • Number of events 8 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.61% 2/329 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Fatigue	30.9% 307/993 • Number of events 308 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	30.7% 101/329 • Number of events 101 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	33.2% 110/331 • Number of events 113 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Asthenia	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.61% 2/329 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Chest pain	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.60% 2/331 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Injection site bruising	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Pain	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Pyrexia	1.4% 14/993 • Number of events 14 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	1.8% 6/329 • Number of events 6 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	2.4% 8/331 • Number of events 8 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Vaccination site pain	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Administration site pain	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Injection site pain	59.9% 595/993 • Number of events 596 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	61.1% 201/329 • Number of events 201 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	60.4% 200/331 • Number of events 201 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Oedema peripheral	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Peripheral swelling	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Axillary pain	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Feeling abnormal	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Ill-defined disorder	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Injection site haematoma	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Injection site haemorrhage	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Injection site hypoaesthesia	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Injection site induration	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Injection site scar	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Injection site swelling	7.8% 77/993 • Number of events 77 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	10.0% 33/329 • Number of events 33 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	5.1% 17/331 • Number of events 17 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Injection site warmth	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Swelling face	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Vaccination site erythema	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Nasopharyngitis	0.40% 4/993 • Number of events 4 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Herpes zoster	0.30% 3/993 • Number of events 3 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	1.2% 4/331 • Number of events 4 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Urinary tract infection	0.40% 4/993 • Number of events 4 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Upper respiratory tract infection	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Gastroenteritis viral	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Cystitis	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Oral herpes	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Rhinitis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Bronchitis	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Conjunctivitis	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Infections and infestations Bacterial infection	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Balance disorder	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Cognitive disorder	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Hypertonia	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Migraine	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Neuralgia	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Presyncope	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Sciatica	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Sinus headache	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Syncope	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Transient ischaemic attack	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Nervous system disorders Tremor	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Diarrhoea	0.40% 4/993 • Number of events 4 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Nausea	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Abdominal pain upper	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Constipation	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Toothache	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Abdominal pain	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Dysphagia	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Gastritis	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Lip blister	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Mouth ulceration	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Oral pain	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Gastrointestinal disorders Vomiting	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Cough	0.50% 5/993 • Number of events 5 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.91% 3/329 • Number of events 3 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.60% 2/331 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Productive cough	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Dysphonia	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Fall	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Foot fracture	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Ligament sprain	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Limb injury	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Tooth fracture	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Animal bite	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Ankle fracture	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Arthropod bite	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Bursa injury	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Contusion	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Hand fracture	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Muscle contusion	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Skin and subcutaneous tissue disorders Pruritus	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.91% 3/329 • Number of events 3 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Skin and subcutaneous tissue disorders Erythema	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Skin and subcutaneous tissue disorders Rash	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.61% 2/329 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Skin and subcutaneous tissue disorders Dermal cyst	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Skin and subcutaneous tissue disorders Dermatitis	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Skin and subcutaneous tissue disorders Granuloma annulare	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Skin and subcutaneous tissue disorders Rosacea	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Skin and subcutaneous tissue disorders Solar dermatitis	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Skin and subcutaneous tissue disorders Urticaria	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Metabolism and nutrition disorders Hypercholesterolaemia	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Metabolism and nutrition disorders Gout	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Metabolism and nutrition disorders Dehydration	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Vascular disorders Hypertension	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Vascular disorders Aortic aneurysm	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Vascular disorders Flushing	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Vascular disorders Hypotension	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Vascular disorders Orthostatic hypotension	0.10% 1/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Renal and urinary disorders Chronic kidney disease	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Renal and urinary disorders Dysuria	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Renal and urinary disorders Pollakiuria	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Renal and urinary disorders Urinary retention	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Ear and labyrinth disorders Ear pain	0.20% 2/993 • Number of events 2 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Ear and labyrinth disorders Ear discomfort	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Ear and labyrinth disorders Vertigo	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Cardiac disorders Angina pectoris	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Cardiac disorders Palpitations	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Eye disorders Eye haemorrhage	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Eye disorders Lacrimation increased	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/329 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Investigations Heart rate increased	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Investigations Liver function test increased	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Psychiatric disorders Agitation	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Psychiatric disorders Insomnia	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Endocrine disorders Goitre	0.00% 0/993 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.30% 1/331 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Endocrine disorders Hypothyroidism	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Immune system disorders Seasonal allergy	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.10% 1/993 • Number of events 1 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/329 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	0.00% 0/331 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)
General disorders Injection site erythema	10.0% 99/993 • Number of events 99 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	11.6% 38/329 • Number of events 38 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)	6.9% 23/331 • Number of events 23 • Serious Adverse Events (SAEs) were collected from Day 1 to Month 12. Non-serious adverse (Other Adverse events) events were collected within 30 days following first vaccination (vaccine administered at Day 1)

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

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

Restriction type: OTHER