Trial Outcomes & Findings for A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 60 Years and Above (NCT NCT04841577)

NCT ID: NCT04841577

Last Updated: 2024-09-03

Results Overview

The serum neutralization assay is a functional assay that measures the ability of serum antibodies to neutralize RSV-A entry and replication in a host cell line. The serum neutralizing antibody titer is expressed in ED60 (Estimated Dilution 60) and corresponds to the inverse of the interpolated serum dilution that yields a 60% reduction of the signal compared to a control without serum.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 976 participants
• Primary outcome timeframe: At 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)
• Results posted on: 2024-09-03

Participant Flow

Out of 976 participants enrolled in the study, 86 participants were not assigned to any study group and 5 participants did not receive any study treatment. 885 participants were vaccinated and included in the Exposed Set.

Participant milestones

Measure	Co-Ad Group Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
Overall Study STARTED	442	443
Overall Study COMPLETED	429	417
Overall Study NOT COMPLETED	13	26

Reasons for withdrawal

Measure	Co-Ad Group Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
Overall Study Adverse Event	5	10
Overall Study Lost to Follow-up	8	7
Overall Study CONSENT WITHDRAWAL, NOT DUE TO A (S)AE	0	8
Overall Study Other	0	1

Baseline Characteristics

A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 60 Years and Above

Baseline characteristics by cohort

Measure	Co-Ad Group n=442 Participants Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=443 Participants Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.	Total n=885 Participants Total of all reporting groups
Age, Continuous	68.4 Years STANDARD_DEVIATION 6.9 • n=5 Participants	68.6 Years STANDARD_DEVIATION 6.9 • n=7 Participants	68.5 Years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	228 Participants n=5 Participants	228 Participants n=7 Participants	456 Participants n=5 Participants
Sex: Female, Male Male	214 Participants n=5 Participants	215 Participants n=7 Participants	429 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Black Or African American	72 Participants n=5 Participants	70 Participants n=7 Participants	142 Participants n=5 Participants
Race/Ethnicity, Customized Maori	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Mixed Race	218 Participants n=5 Participants	227 Participants n=7 Participants	445 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian Or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Other, Not Specified	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White	137 Participants n=5 Participants	135 Participants n=7 Participants	272 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)

Population: The analysis was performed on the Per Protocol set (PPS) which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.

The serum neutralization assay is a functional assay that measures the ability of serum antibodies to neutralize RSV-A entry and replication in a host cell line. The serum neutralizing antibody titer is expressed in ED60 (Estimated Dilution 60) and corresponds to the inverse of the interpolated serum dilution that yields a 60% reduction of the signal compared to a control without serum.

Outcome measures

Measure	Co-Ad Group n=427 Participants Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=398 Participants Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
RSV-A Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMTs)	10060.5 Titers (ED 60) Interval 9126.0 to 11090.7	12255 Titers (ED 60) Interval 11160.4 to 13456.9

PRIMARY outcome

Timeframe: 1 month after the FLU vaccine dose (at Day 31)

Population: The analysis was performed on the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.

HI antibody titers were assessed for each of the Flu vaccine strains, namely Flu A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). The serum HI antibody titers are expressed in 1/Dilution (DIL) where DIL corresponds to the highest dilution that shows complete HI.

Outcome measures

Measure	Co-Ad Group n=427 Participants Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=411 Participants Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
Hemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs Flu A/Hong Kong/2671/2019 H3N2	295.2 Titers (1/DIL) Interval 263.6 to 330.6	346.8 Titers (1/DIL) Interval 306.6 to 392.3
Hemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs Flu A/Victoria/2570/2019 H1N1	267.1 Titers (1/DIL) Interval 235.6 to 302.8	325.4 Titers (1/DIL) Interval 282.5 to 374.9
Hemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs Flu B/Phuket/3073/2013 Yamagata	28.9 Titers (1/DIL) Interval 26.0 to 32.1	34.8 Titers (1/DIL) Interval 31.1 to 39.0
Hemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs Flu B/Washington/02/2019 Victoria	41.6 Titers (1/DIL) Interval 37.1 to 46.6	47.9 Titers (1/DIL) Interval 41.9 to 54.8

SECONDARY outcome

Timeframe: 1 month after the FLU vaccine dose (at Day 31)

Population: The analysis was performed on the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.

SCR for HI antibody response was defined as the percentage of vaccinees who have either a HI pre-dose titer < 1:10 and a post-dose titer >= 1:40 or a pre-dose titer >= 1:10 and at least a four-fold increase in post-dose titer. HI antibody titers were assessed for each of the Flu vaccine strains, namely Flu A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria).

Outcome measures

Measure	Co-Ad Group n=427 Participants Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=411 Participants Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
Secondary: HI Seroconversion Status for Each of the Flu Vaccine Strains Expressed as Seroconversion Rate (SCR) Flu B/Phuket/3073/2013 Yamagata	28.8 Percentage of participants Interval 24.6 to 33.4	32.8 Percentage of participants Interval 28.3 to 37.6
Secondary: HI Seroconversion Status for Each of the Flu Vaccine Strains Expressed as Seroconversion Rate (SCR) Flu B/Washington/02/2019 Victoria	35.6 Percentage of participants Interval 31.1 to 40.3	36 Percentage of participants Interval 31.4 to 40.9
Secondary: HI Seroconversion Status for Each of the Flu Vaccine Strains Expressed as Seroconversion Rate (SCR) Flu A/Hong Kong/2671/2019 H3N2	54.3 Percentage of participants Interval 49.5 to 59.1	56.9 Percentage of participants Interval 52.0 to 61.8
Secondary: HI Seroconversion Status for Each of the Flu Vaccine Strains Expressed as Seroconversion Rate (SCR) Flu A/Victoria/2570/2019 H1N1	78.9 Percentage of participants Interval 74.7 to 82.7	83.5 Percentage of participants Interval 79.5 to 86.9

SECONDARY outcome

Timeframe: 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)

Population: The analysis was performed on the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.

MGI was defined as the geometric mean of the within participant ratios of the post dose titer over the pre-dose titer.

Outcome measures

Measure	Co-Ad Group n=427 Participants Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=398 Participants Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
RSV-A Neutralization Antibody Titers Expressed as Mean Geometric Increase (MGI)	9.61 Ratio Interval 8.7 to 10.61	12.95 Ratio Interval 11.75 to 14.28

SECONDARY outcome

Timeframe: 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)

Population: The analysis was performed on the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.

The serum neutralization assay is a functional assay that measures the ability of serum antibodies to neutralize RSV-B entry and replication in a host cell line. The serum neutralizing antibody titer is expressed in ED60 (Estimated Dilution 60) and corresponds to the inverse of the interpolated serum dilution that yields a 60% reduction of the signal compared to a control without serum.

Outcome measures

Measure	Co-Ad Group n=212 Participants Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=206 Participants Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
RSV-B Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMT)	10518.6 Titers (ED 60) Interval 9302.0 to 11894.3	14349.7 Titers (ED 60) Interval 12640.6 to 16289.9

SECONDARY outcome

Timeframe: 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)

Population: The analysis was performed on a subset of the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.

MGI was defined as the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.

Outcome measures

Measure	Co-Ad Group n=212 Participants Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=206 Participants Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
RSV-B Neutralization Antibody Titers Expressed as MGI	7.67 Ratio Interval 6.76 to 8.72	9.28 Ratio Interval 8.06 to 10.69

SECONDARY outcome

Timeframe: At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31)

Population: The analysis was performed on the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.

HI antibody titers were assessed for each of the Flu vaccine strains, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). The serum HI antibody titers are expressed in 1/DIL where DIL corresponds to the highest dilution that shows complete HI.

Outcome measures

Measure	Co-Ad Group n=435 Participants Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=437 Participants Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs Flu B/Washington/02/2019 Victoria, Day 1	12.2 Titers (1/DIL) Interval 11.1 to 13.4	13.5 Titers (1/DIL) Interval 12.2 to 15.1
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs Flu B/Washington/02/2019 Victoria, Day 31	41.6 Titers (1/DIL) Interval 37.1 to 46.6	47.9 Titers (1/DIL) Interval 41.9 to 54.8
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs Flu A/Hong Kong/2671/2019 H3N2, Day 1	61.4 Titers (1/DIL) Interval 53.8 to 69.9	63.3 Titers (1/DIL) Interval 55.7 to 71.9
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs Flu A/Hong Kong/2671/2019 H3N2, Day 31	295.2 Titers (1/DIL) Interval 263.6 to 330.6	346.8 Titers (1/DIL) Interval 306.6 to 392.3
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs Flu A/Victoria/2570/2019 H1N1, Day 1	20 Titers (1/DIL) Interval 18.0 to 22.3	19.9 Titers (1/DIL) Interval 17.8 to 22.2
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs Flu A/Victoria/2570/2019 H1N1, Day 31	267.1 Titers (1/DIL) Interval 235.6 to 302.8	325.4 Titers (1/DIL) Interval 282.5 to 374.9
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs Flu B/Phuket/3073/2013 Yamagata, Day 1	10.4 Titers (1/DIL) Interval 9.5 to 11.3	10.8 Titers (1/DIL) Interval 9.9 to 11.7
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as GMTs Flu B/Phuket/3073/2013 Yamagata, Day 31	28.9 Titers (1/DIL) Interval 26.0 to 32.1	34.8 Titers (1/DIL) Interval 31.1 to 39.0

SECONDARY outcome

Timeframe: At baseline (at Day 1) and 1 month after the FLU vaccine dose (at Day 31)

Population: The analysis was performed on the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.

SPR for HI antibody response was defined as percentage of vaccinees with a serum HI titer >= 1:40 that usually is accepted as indicating protection. HI antibody titers were assessed for each of the Flu vaccine strains, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria).

Outcome measures

Measure	Co-Ad Group n=435 Participants Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=437 Participants Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR) Flu B/Phuket/3073/2013 Yamagata, Day 31	47.8 Percentage of participants Interval 43.0 to 52.6	54.3 Percentage of participants Interval 49.3 to 59.2
HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR) Flu A/Hong Kong/2671/2019 H3N2, Day 1	70.8 Percentage of participants Interval 66.3 to 75.0	70.3 Percentage of participants Interval 65.7 to 74.5
HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR) Flu A/Hong Kong/2671/2019 H3N2, Day 31	97.4 Percentage of participants Interval 95.4 to 98.7	97.1 Percentage of participants Interval 95.0 to 98.5
HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR) Flu A/Victoria/2570/2019 H1N1, Day 1	35.4 Percentage of participants Interval 30.9 to 40.1	34.6 Percentage of participants Interval 30.1 to 39.2
HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR) Flu A/Victoria/2570/2019 H1N1, Day 31	94.6 Percentage of participants Interval 92.0 to 96.6	93.4 Percentage of participants Interval 90.6 to 95.6
HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR) Flu B/Phuket/3073/2013 Yamagata, Day 1	14.3 Percentage of participants Interval 11.1 to 17.9	14.9 Percentage of participants Interval 11.7 to 18.6
HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR) Flu B/Washington/02/2019 Victoria, Day 1	20 Percentage of participants Interval 16.3 to 24.1	23.6 Percentage of participants Interval 19.7 to 27.8
HI Seroprotection Status for Each of the FLU Vaccine Strains Expressed as Seroprotection Rate (SPR) Flu B/Washington/02/2019 Victoria, Day 31	59.3 Percentage of participants Interval 54.4 to 64.0	61.3 Percentage of participants Interval 56.4 to 66.0

SECONDARY outcome

Timeframe: 1 month after the FLU vaccine dose (at Day 31)

Population: The analysis was performed on the PPS which consisted of all eligible participants who received at least 1 study intervention as per protocol, had immunogenicity results pre-post-dose for at least 1 antigen, complied with blood draw intervals and contribution of participants to PPS at specific timepoint will be defined by timepoint, without intercurrent medical conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.

MGI was defined as the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer. HI antibody were assessed for each of the FLUvaccine strain, namely A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria).

Outcome measures

Measure	Co-Ad Group n=427 Participants Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=410 Participants Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as MGI Flu A/Hong Kong/2671/2019 H3N2	4.81 Ratio Interval 4.22 to 5.48	5.50 Ratio Interval 4.81 to 6.29
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as MGI Flu A/Victoria/2570/2019 H1N1	13.36 Ratio Interval 11.58 to 15.42	16.25 Ratio Interval 14.08 to 18.76
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as MGI Flu B/Phuket/3073/2013 Yamagata HI	2.82 Ratio Interval 2.55 to 3.12	3.22 Ratio Interval 2.9 to 3.58
HI Antibody Titers for Each of the FLU Vaccine Strains Expressed as MGI Flu B/Washington/02/2019 Victoria	3.43 Ratio Interval 3.06 to 3.85	3.60 Ratio Interval 3.18 to 4.08

SECONDARY outcome

Timeframe: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination

Population: The analysis was performed on the Exposed set, which included All participants who received a study intervention. Analysis per group is based on the study intervention administered. RSV vaccine was administered at day 1 for the control group and at day 31 for the Co-Ad group.

Solicited administration site adverse events(AEs) assessed were erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade.

Outcome measures

Measure	Co-Ad Group n=438 Participants Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=438 Participants Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
Percentage of Participants With Solicited Administration Site Events Erythema against Flu Dose given at Day 1	1.1 Percentage of participants Interval 0.4 to 2.6	0.5 Percentage of participants Interval 0.1 to 1.6
Percentage of Participants With Solicited Administration Site Events Erythema against RSV Dose given at Day 1	4.1 Percentage of participants Interval 2.5 to 6.4	—
Percentage of Participants With Solicited Administration Site Events Erythema against RSV Dose given at Day 31	—	2.1 Percentage of participants Interval 1.0 to 4.0
Percentage of Participants With Solicited Administration Site Events Pain against Flu Dose given at Day 1	28.3 Percentage of participants Interval 24.1 to 32.8	20.5 Percentage of participants Interval 16.9 to 24.6
Percentage of Participants With Solicited Administration Site Events Pain against RSV Dose given at Day 1	47.9 Percentage of participants Interval 43.2 to 52.7	—
Percentage of Participants With Solicited Administration Site Events Pain against RSV Dose give at Day 31	—	39.1 Percentage of participants Interval 34.4 to 44.0
Percentage of Participants With Solicited Administration Site Events Swelling against Flu Dose given at Day 1	1.4 Percentage of participants Interval 0.5 to 3.0	0.7 Percentage of participants Interval 0.1 to 2.0
Percentage of Participants With Solicited Administration Site Events Swelling against RSV Dose given at Day 1	3.2 Percentage of participants Interval 1.8 to 5.3	—
Percentage of Participants With Solicited Administration Site Events Swelling against RSV Dose given at Day 31	—	1 Percentage of participants Interval 0.3 to 2.4

SECONDARY outcome

Timeframe: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination

Population: The analysis was performed on the Exposed set, which included All participants who received a study intervention. Analysis per group is based on the study intervention administered. The Co-Ad group only received vaccination at Day 1.

Solicited systemic events assessed were arthralgia, fatigue, fever [defined as temperature equal to or above (>=) 38 degrees Celsius (C)/100.4 degrees Fahrenheit (F)], headache and myalgia. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.

Outcome measures

Measure	Co-Ad Group n=438 Participants Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=438 Participants Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
Percentage of Participants With Solicited Systemic Events Headache, Dosing at Day 1	21.7 Percentage of participants Interval 17.9 to 25.8	12.8 Percentage of participants Interval 9.8 to 16.3
Percentage of Participants With Solicited Systemic Events Arthralgia, Dosing at Day 1	16.2 Percentage of participants Interval 12.9 to 20.0	4.8 Percentage of participants Interval 3.0 to 7.2
Percentage of Participants With Solicited Systemic Events Arthralgia, Dosing at Day 31	—	11.2 Percentage of participants Interval 8.4 to 14.6
Percentage of Participants With Solicited Systemic Events Fatigue, Dosing at Day 1	22.4 Percentage of participants Interval 18.6 to 26.6	12.8 Percentage of participants Interval 9.8 to 16.3
Percentage of Participants With Solicited Systemic Events Fatigue, Dosing at Day 31	—	17.9 Percentage of participants Interval 14.3 to 21.9
Percentage of Participants With Solicited Systemic Events Fever, Dosing at Day 1	2.5 Percentage of participants Interval 1.3 to 4.4	0.7 Percentage of participants Interval 0.1 to 2.0
Percentage of Participants With Solicited Systemic Events Fever, Dosing at Day 31	—	1 Percentage of participants Interval 0.3 to 2.4
Percentage of Participants With Solicited Systemic Events Headache, Dosing at Day 31	—	16.2 Percentage of participants Interval 12.8 to 20.1
Percentage of Participants With Solicited Systemic Events Myalgia, Dosing at Day 1	22.1 Percentage of participants Interval 18.3 to 26.3	9.4 Percentage of participants Interval 6.8 to 12.5
Percentage of Participants With Solicited Systemic Events Myalgia, Dosing at Day 31	—	19.6 Percentage of participants Interval 15.9 to 23.7

SECONDARY outcome

Timeframe: Within 30 days (the day of vaccination and 29 subsequent days) after each vaccination

Population: The analysis was performed on the Exposed set, which included All participants who received a study intervention. Analysis per group is based on the study intervention administered.

An unsolicited AEs is any AE reported in addition to those solicited during the clinical study and that was not included in a list of solicited events using a Participant Diary. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Unsolicited AEs include serious, non-serious AEs and potential immune-mediated diseases (pIMDs). Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	Co-Ad Group n=442 Participants Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=443 Participants Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
Percentage of Participants Reporting at Least One Unsolicited Adverse Event	18.8 Percentage of participants Interval 15.2 to 22.7	23.7 Percentage of participants Interval 19.8 to 27.9

SECONDARY outcome

Timeframe: From Day 1 up to study end (6 months after last vaccination)

Population: The analysis was performed on the Exposed set, which included All participants who received a study intervention. Analysis per group is based on the study intervention administered.

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, is a congenital anomaly/birth defect in the offspring of a study participant. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.

Outcome measures

Measure	Co-Ad Group n=442 Participants Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=443 Participants Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
Percentage of Participants Reporting at Least One Serious Adverse Event (SAE)	3.4 Percentage of Participants Interval 1.9 to 5.5	4.5 Percentage of Participants Interval 2.8 to 6.9

SECONDARY outcome

Timeframe: From Day 1 up to study end (6 months after last vaccination)

Population: The analysis was performed on the Exposed set, which included All participants who received a study intervention. Analysis per group is based on the study intervention administered.

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	Co-Ad Group n=442 Participants Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=443 Participants Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMD)	1.1 Percentage of participants Interval 0.4 to 2.6	0.2 Percentage of participants Interval 0.0 to 1.3

Adverse Events

Co-Ad Group

Serious events: 15 serious events

Other events: 290 other events

Deaths: 4 deaths

Control Group

Serious events: 20 serious events

Other events: 276 other events

Deaths: 8 deaths

Serious adverse events

Measure	Co-Ad Group n=442 participants at risk Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=443 participants at risk Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
Blood and lymphatic system disorders Anaemia	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Cardiac disorders Cardiac failure congestive	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Eye disorders Eye pain	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Gastrointestinal disorders Food poisoning	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Death	0.90% 4/442 • Number of events 4 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	1.8% 8/443 • Number of events 8 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Diverticulitis	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations COVID-19	0.45% 2/442 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.68% 3/443 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations COVID-19 pneumonia	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Suspected COVID-19	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.68% 3/443 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Wound infection	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Urinary tract infection	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Subdural haematoma	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Metabolism and nutrition disorders Hyponatraemia	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Musculoskeletal and connective tissue disorders Back pain	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma stage I	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Nervous system disorders Cerebral haemorrhage	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Nervous system disorders Dementia	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Nervous system disorders Acute disseminated encephalomyelitis	0.45% 2/442 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Nervous system disorders Syncope	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).

Other adverse events

Measure	Co-Ad Group n=442 participants at risk Participants received 1 dose of RSV\_PreF3 Older Adult (OA) investigational vaccine and 1 dose of FLU-QIV at Day 1 and were followed up until the study end.	Control Group n=443 participants at risk Participants received 1 dose of FLU-QIV at Day 1 and 1 dose of RSV\_PreF3 OA investigational vaccine at Day 31 and were followed up until the study end.
General disorders Injection site pain	53.4% 236/442 • Number of events 236 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	43.3% 192/443 • Number of events 254 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Fatigue	22.6% 100/442 • Number of events 102 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	23.9% 106/443 • Number of events 133 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Injection site erythema	4.8% 21/442 • Number of events 21 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	2.5% 11/443 • Number of events 11 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Injection site swelling	3.6% 16/442 • Number of events 16 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	1.8% 8/443 • Number of events 8 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Pyrexia	3.2% 14/442 • Number of events 14 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	1.4% 6/443 • Number of events 7 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Injection site bruising	0.68% 3/442 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Injection site pruritus	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.68% 3/443 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Pain	0.68% 3/442 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Influenza like illness	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.45% 2/443 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Administration site swelling	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Asthenia	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Chest pain	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Chills	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Feeling cold	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Injection site discolouration	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Malaise	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Peripheral swelling	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Thirst	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Vaccination site bruising	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
General disorders Vaccination site pain	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Musculoskeletal and connective tissue disorders Myalgia	22.2% 98/442 • Number of events 101 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	22.6% 100/443 • Number of events 125 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Musculoskeletal and connective tissue disorders Arthralgia	16.5% 73/442 • Number of events 73 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	13.5% 60/443 • Number of events 73 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Musculoskeletal and connective tissue disorders Back pain	0.68% 3/442 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.68% 3/443 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Musculoskeletal and connective tissue disorders Pain in extremity	0.45% 2/442 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.68% 3/443 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Musculoskeletal and connective tissue disorders Neck pain	0.68% 3/442 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.45% 2/443 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Musculoskeletal and connective tissue disorders Muscle spasms	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Musculoskeletal and connective tissue disorders Muscular weakness	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Nervous system disorders Headache	22.4% 99/442 • Number of events 112 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	23.3% 103/443 • Number of events 134 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Nervous system disorders Dizziness	0.45% 2/442 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Nervous system disorders Tremor	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.45% 2/443 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Nervous system disorders Hypokinesia	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Nervous system disorders Migraine	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Nervous system disorders Paraesthesia	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Upper respiratory tract infection	0.90% 4/442 • Number of events 4 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	2.3% 10/443 • Number of events 11 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations COVID-19	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	1.1% 5/443 • Number of events 5 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Viral upper respiratory tract infection	0.45% 2/442 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.45% 2/443 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Influenza	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.45% 2/443 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Nasopharyngitis	0.45% 2/442 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Respiratory tract infection viral	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.45% 2/443 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Sinusitis	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.45% 2/443 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Tooth abscess	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.45% 2/443 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Lower respiratory tract infection	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.45% 2/443 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Nail infection	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Respiratory tract infection	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Tooth infection	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.45% 2/443 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Urinary tract infection	0.45% 2/442 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Bronchitis	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Cystitis	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Gastroenteritis	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Gastroenteritis viral	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Gingivitis	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Helicobacter infection	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Oral herpes	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Paronychia	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Pharyngitis	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Postoperative wound infection	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Rhinitis	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Skin candida	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Infections and infestations Suspected COVID-19	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Cough	2.0% 9/442 • Number of events 9 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.68% 3/443 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.68% 3/442 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.45% 2/442 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.45% 2/443 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.68% 3/442 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.45% 2/443 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.23% 1/442 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.45% 2/443 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Productive cough	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Sinonasal obstruction	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Gastrointestinal disorders Diarrhoea	0.45% 2/442 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.68% 3/443 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Gastrointestinal disorders Nausea	0.68% 3/442 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Gastrointestinal disorders Toothache	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.68% 3/443 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Gastrointestinal disorders Vomiting	0.45% 2/442 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.45% 2/443 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.68% 3/443 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Gastrointestinal disorders Abdominal pain lower	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Gastrointestinal disorders Constipation	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Gastrointestinal disorders Dental caries	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Gastrointestinal disorders Oral pain	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Gastrointestinal disorders Proctalgia	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Fall	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.68% 3/443 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.68% 3/443 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Limb injury	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Procedural pain	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Animal bite	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Contusion	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Foot fracture	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Muscle strain	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Procedural complication	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Skin laceration	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Spinal column injury	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Tendon injury	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Skin and subcutaneous tissue disorders Urticaria	0.23% 1/442 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Skin and subcutaneous tissue disorders Dermatosis	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Skin and subcutaneous tissue disorders Erythema	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Skin and subcutaneous tissue disorders Rash	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Skin and subcutaneous tissue disorders Skin lesion	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Vascular disorders Hypertension	0.45% 2/442 • Number of events 2 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	1.8% 8/443 • Number of events 8 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Vascular disorders Hot flush	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Metabolism and nutrition disorders Decreased appetite	0.68% 3/442 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Metabolism and nutrition disorders Gout	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Cardiac disorders Palpitations	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Cardiac disorders Bradycardia	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.45% 2/442 • Number of events 3 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Psychiatric disorders Anxiety	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Psychiatric disorders Insomnia	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Ear and labyrinth disorders Meniere's disease	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Endocrine disorders Hypothyroidism	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Eye disorders Lacrimation increased	0.00% 0/442 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.23% 1/443 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Investigations Faecal volume increased	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.23% 1/442 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).	0.00% 0/443 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Study end (6 months after last vaccination)).

Additional Information

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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